INDIVIDUALS ASSOCIATED WITH RESEARCH/TEACHING OF THIS PROTOCOL:

PROJECT PARTICIPANTS

1. Name Keith Brown FFAFP (US), FRSTMH (UK), CTM (UK)Degree/Title MD, Chief Medical OfficerAddress 2505 Crown Road, Norfolk, Nebraska, 68701Email drbrown@gorgroup.com

Experience: Co-owner of Global Operational Resources Group. Inc. He also serves an Assistant Professor at the University Of Nebraska School of Medicine (US) and as a board member/Trustee on The Millennium Health Foundation (UK) and Belize Institute for Tropical and Wilderness Medicine.Prior to entering medical school Dr. Brown served 10 years in the United States Air Force and as a civilian law enforcement officer, firefighter and paramedic. He has extensive technical rescue, tactical and specialist qualifications in addition to his medical qualifications in family, tropical and travel medicine.Active in teaching all over the world. Dr. Brown is a frequent speaker at conferences as well as remote, expedition and tactical medicine programs. He has extensive experience in the use of tissue training platforms in high-fidelity and field exercises, and is IACUC Basic and Advantage certified by the USDA.

Role in Study: The Doctor will write and/or guide the development of lesson plans and materials pertinent to the study. The Medical Doctor or his representative will supervise and instruct any and all clinical medical surgical procedures performed on the animals:In this protocol, the Doctor will:Conduct an immediate assessment of each animal involved in the study it needed.Administer or supervise all animal anesthesiaMay conduct and or supervise the surgical procedures as they are performed.Administer euthanasia to the animals or pronounce death upon termination of the study.

Role in Study: Serve as Director of the medical training program. Duties involve direct instruction and supervision of all of the participants (students, instructors and the veterinarians) in the medical training program. Additional duties include lesson preparation, presentation and supervision of lecturers. Serve as the liaison between Global Operational Resources Group and the IACUC.

2. Name Dale Ferguson Degree/Title PhD. Microbiology/IACUC ChairmanAddress 3803 Carnation Lane, Paron, Arkansas 72122E-mail dandbferguson@msn.com

Experience: 34 years of academic experience at the University of Arkansas at Little Rock. In addition to teaching classes in microbiology, medical microbiology and immunology, served as chairperson of IACUC for approximately 20 years. Experience includes Director of Basic Animal Services unit at the University of Arkansas at Little Rock for approximately 10 years. The facility was USDA, APHIS and AAALAC certified. Professional experience involves consulting for a number of private companies working in veterinary related activities involving both large and small animals.

Role in Study:Serve as IACUC chairmanGuide procedural and administrative action of both the IACUC and use of this protocol.Reports to company president all IACUC findings and observations made during working at the training facility.Co-direct instruction and supervision of participants and instructors during all animal interactions. Assist veterinarian in administrating initial anesthesia as well as monitor animal anesthesia.

3. Name Cliff Peck IVDegree/Title Dr. veterinary medicine/Attending VeterinarianAddress 2606 Ferndale Cutoff Road, Little Rock, Arkansas 72223E-mail

Experience during the course of his academic studies Dr. Peck worked with the Louisiana State penal system swine farms. His duties included establishing procedures and policies to ensure the general health if the herd. At designated times individual animals were removed, sacrificed and necropsied to perform a battery of test to evaluate the overall health of the herd.Previous experience as Chief Consulting Veterinarian for a live tissue program in Little Rock Arkansas utilising both porcine and caprine models

Role in Study:In this protocol, the attending veterinarian will:Sit as a member of IACUC Establish all policies and procedures involved with animal use and animal husbandry within this protocol.Establish a program of veterinary care (if applicable) and fill out APHIS forms (APHIS 7002) accordingly.Establish an animal use/care SOP.If the attending vet works at the training facility he will:Conduct an immediate assessment of each animal involved in the study.Administer or supervise all animal anesthesia.May conduct and or supervise the surgical procedures as they are performed.Administer euthanasia to the animals or pronounce death upon termination of the study.

4. Name Samantha RayDegree/Title: Consultant veterinarianAddress 130 Summit Valley Circle, Maumelle, AR 72113 E-mail: ryan_and_sami@yahoo.com

Experience: Dr. Ray is a graduate of Louisiana State University veterinary school. Since graduation she has been employed at an emergency veterinary clinic in Little Rock, AR. In addition, she is employed half-time at the Doubletree Veterinary Clinic in Little Rock, AR. This clinic would be described as having a mixed practice, including both small and large animals. Although Dr. Ray’s specializes in small animals, she has experience working with swine and caprine.

Role in Study:Dr. Ray will serve as the consulting veterinarian for Global Operations Resources Group Inc. As such she will assume the duties of the attending veterinarian in his absence. In addition, Dr. Ray will serve as a member of the IACUC, She, in consulting with the attending veterinarian, will develop the animal care and use program. She will also assist the attending veterinarian in establishing a program of veterinary care for animals involved in protocols that came before the IACUC.Conduct an immediate assessment of each animal involved in the study.Administer or supervise all animal anesthesia.May conduct and or supervise the surgical procedures as they are performed.Administer euthanasia to the animals or pronounce death upon termination of the study.

I. Non-Technical Synopsis

This protocol develops abilities of both medically trained and untrained personnel caring for battlefield casualties or any type of catastrophic point of injury event. This projects goal is to develop skills and techniques to deliver the most comprehensive care possible under simulated combat conditions using animal models to simulate human injuries.

Combat injury types and distribution are well documented. Battlefield medicine is conducted under extremely non-ideal conditions. Tactical situations often force contradictory choices between good medicine and good tactics “ Good medicine is often bad tactics and bad tactics can get everyone killed” This protocol supports training for these hard decisions. Training to find the balance between medicine and tactics increases everyone’s survivability-both the patient and the care giver.

In addition to training for care under fire in the field, another goal of this project is to develop more definitive treatment skills that the provider can utilize to further stabilize their patient. While this care may be delivered in a clinic, it can also be delivered in more austere conditions.

All medical training, whether it be tactical or clinical in nature will be supervised by medically qualified individuals.

A veterinarian or designated representative will ensure anesthetization of the animal before any procedure. The animal will remain anesthetized for the duration of training. No animal will be recovered or withdrawn from anesthesia once any wounding has taken place. A veterinarian or designated representative shall pronounce death or administer euthanasia to the animal upon conclusion of training.

II. BACKGROUND

II.1. Background: Realistic combat medical training is irreplaceable. The use of a live tissue model facilitates the participants achieving a very high level of proficiency in patient management under stressful conditions. More specifically the participants learn to rapidly assess then manage a variety of realistically create combat wound simulation in a real time environment with immediate feedback on the efficacy of their treatment options. This experience both mental and sensory is not able to be duplicated by the use of manikins or other training aids and cannot be duplicated except in actual battlefield conditions.

II.2. Literature Search for Duplication: This protocol provides below, written assurances that the proposed activities do not unnecessarily duplicate previous or ongoing experiments. It describes methods and sources (journals, abstracts, etc) to support this assurance. It includes the dates the searches were performed, years included in the search, and keywords used.

The goals stated in this protocol are individual and experiential and must be learned and retained through intense repetitive practical, hands-on experience involving direct contact with a live animal. In addition, these skills are highly perishable and must be conducted periodically to maintain a high degree of expertise.

II.2.1 Literature Source(s) Searched:

Biosys - http://www.dtic.mil/biosys/org/md.html - Biomedical links to military branches: US Army Medical Research and Material Command.Crisp – http://crisp.cit.nih.gov/ - Links to branches of the National Institutes of Health, Center for Information Technology, Center for Scientific Review and Center for Research Resources.Brd – http://brd.dtic.mil/ - Links to the Department Of Defence Biomedical research database.Scirus – http://www.sciarus.com/srsapp - Links to Science Direct, Biomed Central and Medicine.

II.2.2 Date of Search:May 20, 2008, February 13, 2007

II.2.3 Period of Search:

1998 – Present (2008)

II.2.4 Key Words and Search Strategy:Multiple key word searches were conducted to answer the questions:Is the conduct of the ATLS animal laboratory justified?Is the use of animals in surgical training justified?Is the use of animals in Combat trauma training justified?Are there available alternatives to use of animals in ATLS practicums, combat trauma training or clinical trauma medical/surgical training?

Search 1 – Date: 5-20-08Key Search Words:Combat Casualty Care (training)Advanced Trauma Life Support (training)Live tissue TrainingLive tissue Training Alternatives Combat Casualty Care AlternativesCombat casualty training Alternatives

II.2.5 Result of Search:

Justification:“The Department of Defence (DOD) use of animals in research, development

and in education and training programs is critical to sustained technological superiority in military operations in defense of out national interests. Many of these programs directly contribute to Force Health Protection, allowing our forces to operate in and survive the numerous and various hazards they face around the world”

“The DOD must develop the material and technological means to provide critical and immediate battlefield injury care to service men and women”

Ref: DOD animal care and use program 2001

Review of the DOD animal use protocols for the past decade demonstrates the involvement of the military in the use of animals in their education and training programs. The listing includes Advanced Trauma Life Support training, Graduate Medical Education, Animal-Handling Techniques and Special Forces Medical Training.

Ref: DOD Animal Care and Use Program 1998 – 2003

“Mostly military health care providers do not willingly become familiar with chemical warfare. This was painfully obvious during Operations Desert Shields/Desert Storm when it soon became apparent that many health care providers knew a little about the effects of chemical agent or the medical defense against them.”Ref: Medical Management of Chemical Casualties Handbook, 1999.

In the biological casualties handbook the text notes the difference between specific therapies and prophylactic regiments for some of the diseases mentioned. The reasons stated are due, in part, to the differences presented when the biological agent presented in weapon form may vary from the endemic form of the disease. “For ethnic reasons, human challenge studies can only be done with a limited number of these agents. Therefore, treatment of prophylaxis regiments may be derived from in vitro data, animal models and limited human data”Ref: Medical Management of Biological Casualties Handbook, 2001 edition.

The need to maintain up to date information concerning both chemicals and biological agents is absolutely necessary. Modification of a chemical agent by addition of radicals may alter the biological manifestations of the newly derived product. As noted above, information from human subjects is limited. Biological agents, with their mutagenic properties, also produce special problems to a susceptible human population. As noted above, information from human subjects is limited. We must be ever diligent to research and investigate the effects of these agents. Therefore, we must use animal models to ascertain some of this critical information. Without doing so we cannot hope to maintain our fighting force in the most optimal conditions.

Trauma training among nonsurgical physicians in the military is highly variable in amount and quality. However, all developed military physicians, regardless of speciality, are expected to provide combat casualty care. The goal was to assess the effectiveness of an intense modular trauma refresher course for nonsurgical physicians deploying to a combat zone. Modules consisted of didactic session, simulation with interactive human surgical simulators, case presentations and triage scenarios from Iraq/Afghanistan with associated skill stations and live tissue surgical procedure laboratory. All military physicians must be prepared to manage combat casualties. This hybrid training model may be an effective method to prepare nonsurgeons to deal with battle injuries. This course significantly improved the knowledge and confidence among primary care physicians.Ref: (2007) Training Physicians for Combat Casualty Care on the Modern Battlefield, J.Surg.Educ 199-203

Selected References:

1. (2001) Clinical Medical Studies in Support of Graduate Medical Education Using Animal Models. Laboratory Animals Training Animal Care ATLS

2. (2002) Advanced Combat Trauma Intervention Training. Laboratory Animals ATLS combat trauma.

3. (2001) Advanced Combat Trauma Intervention Training. Laboratory Animals ATLS combat trauma.

4. (2002) Advanced/Combat Trauma Management Training using Animal Models (Domestic Goat – Capra hircus. Pig – Sus Scrofa and Sheep – Ovis aries) Laboratory Animals in vitro Procedure Alternatives ATLS Life Support Combat Military Trauma Injury Train Teach Educate Instruct Model Method Technique.

Alternatives to Live Tissue:

1. Block, E.F.J. Et.al. Use of a human patient simulator for the advanced trauma life support course. Am. Surg. 68. 648,2002. A highly anticipated and rewarding component of the ATLS program is the surgical skill station Logistic, societal and economic issues have results in development of human patient simulators. These investigations studied the simulator and its acceptance by participants in the ATLS program.

2. Calkins, MD and Robinson. TD, Combat Trauma Airway Management: endotrachael intubation verses laryngeal mask airway verses combitube use by Navy SEAL and Reconnaissance combat corpsman. J. Trauma. 48. 2000. Airway management takes precedence regardless of what type of life support is taking place. The gold standard for airway control and ventilation in the hands of the experienced paramedic remains unarguably the endotrachael tube. Unfortunately, laryngoscopy and endotrachael intubation require a skilled provider who performs this procedure on a frequent basis. A comparison of the techniques were evaluated regardless of the airway device, refresher training must take place frequently.

3. Garrett. H. A Human Cadaveric Circulation Model, J. Vas. Surg. 33 1128-1130. 2002. An apparatus and method for microsurgical training using cadaveric anatomy with filling of the vascular system by fluids under pressure to simulate the appearance and function of live surgery. An opition is to fill the spinal canal with clear fluid to simulate cerebrospinal fluid.

4. Gilbert, MK, Et. Al. A computer based trauma simulator for teaching trauma management skills. Am. J. Surg. 179. 223. 2000. The management of multiple injured trauma patients is a skill requiring broad knowledge, sound judgment and leadership capabilities. This study evaluated the effectiveness of computer based trauma simulator as a teaching tool for medical students. The simulator presentations were compared to seminar teaching groups. A significant benefit is associated with clinically based trauma management courses.

5. (2002) Military Uses Pigs in Trauma Training. Humane Society December 20, 2006. The Humane Society encourages the use of alternatives to live tissue, including sophisticated medical simulators of the human body. These simulators provide the opportunity to gain familiarity and comfort with medical procedures though unlimited repletion, anatomical and physiological realism given the differences between human and animal anatomy. One of the available alternatives is the Trauma Man System, a simulator of the human body used for surgical training that includes the simulated tissue structures and bodily fluids. In 2001 the American College of Surgeons Committee on Trauma Approved the use of Trauma Man for Advanced Trauma Life Support Courses.

6. Kaufmann, C. Trauma Training: virtual reality application. Stud. Health Technol. Inform, 81. 236, 2001. Training medics, medical students, nurses and residents to perform trauma care skills presents many obstacles. Training of

such personnel should be approached in a variety of ways, including virtual reality.

7. Kaufmann, C Zakaluzny, S, Lui, A. First steps in eliminating the need for animals and cadavers in Advanced Trauma Life Support. Medical Image Computing and Computer – Assisted Intervention – Miccai 2000. 1935:618. 2000. The ATLS course is designed to provide for optimal initial resuscitation of the seriously injured patient. The surgical skills component of this course requires the use of cadavers or anesthesized animals. Significant anatomical differences and ethical issues limit the utility if animals.

8. Kuhn. K. Mew Methods for Microsurgical Training. Physicians Committee for Responsible Medicine Magazine. XI Microsurgery involves the repairing of tiny vessels and nerves under an operating microscope. Standard - microsurgery training involves practicing on live, anesthetized rats. Simulators eliminate ethical complications and allows students to practice again and again until the highest level of proficiency is reached.

9. Lee. SK. Et.al. Trauma assessment training with a patient simulator. A prospective, randomized study. Journal of Trauma – Injury Infection and Critical Care. 55:651, 2003. Patient simulators are computer-controlled mannequins that may increase realism during trauma training by providing real-time changes in vital signs and physical findings during trauma scenarios. Investigators hypothesized that trauma assessment training on a patient simulator would be as effective as training with a more traditional moulage patient/actor.

10. Marshall. R.L. Et.al. Use of a patient simulator in the development of residential trauma management skills. J. Trauma. 51. 17. 2001. Computerized human patient simulators have been used to improve diagnostic and therapeutic decision making. This study investigated the impact of simulator ATLS on the development of trauma management skills and self-confidence in interns.

11. Neequaye, S. Et.al. Endovascular skills training and assessment. J Vas. Surg. 46. 1055-1064, 2007. Available alternatives to training on patients include synthetic models, anesthesized animals, human cadavers and virtual reality simulation. Virtual reality is a useful tool enabling objective demonstration of improved skills performance both in simulated performance and in vivo performance.

12. Ritter, EM, Bowyer, MW. Simulation for trauma and combat casualty care Minimally invasive Therapy and Allied Technologies. 14:224, 2005. Simulation applicants ranging form simple physical models to complex, computer-based virual reality systems have either been developed or are being developed to help support and improve trauma care training. Simulator are available for training in the treatment of disorders of the airway, difficulty with breathing and problems dealing with circulation as well as various non-life-threatening but disabling injuries.

13. Scott, B. et. al. Methods and Apparatus for Autonomous Casualty Simulation. Method and apparatus to provide simulation of a human casualty. In one embodiment an autonomous casualty simulator includes processing module having a scenario progression controller and a physiological modelling system to receive sensor input and to control effectors. The autonomous casualty simulator can be contained in a normal human mannequin form.

14. Spitzer, VM, Scherzinger, AL. Virtual Anatomy: An anatomist’s playground. Clinical Anatomy. 19:192. 2006. Authors feel virtual anatomy presents significant advantages over the reality of a cadaver and it provides different views and perspectives, portability and the ability of learning the living body rather than a corpse.

15. Wayne, DB. Et.al. Mastery learning of advanced cardiac life support skills by internal medicine residents using simulation technology and deliberate practice. Journal of Internal Medicine. 21:251, 2006. Ivestigators used a medical simulator to assess skills of residents in ACLS Scenarios.

16. Veterinary Clinics of North America. ‘Food and Animal Practice’ Anesthesia Update Nov. 1996

Selected Citations From Search February 13, 2007 (Animal models, skills, training and techniques)

1. Abu-Zidan. FM. Et.al. Establishment of a teaching model for sonographic diagnosis of trauma. J. Trauma.56. 99. 2004. This study served to establish the pig as a clinically relevant animal model for teaching and training.

2. Aiam. HB. Et.al. Learning and memory is preserved after included asanguineous hyperkalemic hypothermic arrest in a swine model of traumatic exsanguination. Surgery. 132. 278, 2002.

3. Ali. J. Et.al. Swine and dynamic ultrasound models for trauma ultrasound testing of surgical residents. J. Surg. Res. 76. 17, 1998.

4. Ali. J. Et.al. Comparison of performance 2 years after the old and new ATLS courses. J. Surg. Res. 97. 71, 2001. Inclusion of interative type method is much better than noninteractive teaching method.

5. Berg, DA, Et.al. Successful collaborative model for trauma skills training of surgical and emergency medicine residents in a laboratory setting. Curr. Surg. 62. 657. 2005. Emergency, medicine attendings used human volunteers.

Trauma surgery attendings used a porcine model to teach emergency medicine residents tracheostomy, peripheral venous cutdown, diagnostic peritoneal lavage and thoracotomy.

6. Boyer, MW, Liu, AV Bonar, JP. Validation of SimPL- a simulator of diagnostic peritoneal lavage training. Stud. Health Technol Inform. 111.64 2005. These investigations use porcine as an animal model.

7. Calkins, MD, Intraosseous infusion devices: a comparison for potential use in special operations. J. Trauma. 48. 1068. 2000. Study conducted to determine which intraoxxeous device was easy to learn to use, easy to use once the skill was obtained and appropriate for the Special Operations environment.

8. Cloonan. CC. “Don’t just do something, stand there!” to teach or not to teach, that is the question – intravenous fluid resuscitation training for Combat Lifesavers. J. Trauma. 54. S20. 2003. Philosophical article on teaching military personnel administration of intravenous fluids.

9. Gaarder, C. Advanced surgical trauma care training with a live procine model. Injury 36.718. 2005. Evaluated the benefit of a compulsory operative trauma care course for general surgeons in Norway utilizing a live procine model. The operative trauma care animal session increased the participants perceived competence significantly. It use seems justified for education in trauma related lifesaving surgical precedures.

10. Hohlrieder. M. Et.al Guided insertion of the ProSeal laryngeal mask airway is superior to conventional tracheal inturbation by first-month anesthesia residents after brief manikin-only training. Anesth. Analg. 103.458.2006. Investigators concluded practice on patients was remarkably better than brief training than brief manikin only training.

11. Jacobs, LM, Lorenzo, C, Brautigam, RT. Definitive surgical trauma care live porcine session: a technique for training in trauma surgery. Conn Med. 65. 265. 2001, An operative animal surgery section employing swine to teach penetrating injuries to internal organs, circulatory system and urinary tract.

12. Maharaj, CH, Et.al. Learning and performance of tracheal intubation by novice personnel: a comparison of the Airtaq and Macintosh laryngoscope. Anesthesia.61. 671. 2006. Direct laryngoscopic tracheal intubation is taught to many health care professionals as it is a potentially lifesaving procedure.

13. Moses. G. Military medical modelling and simulation in the 21st century. Stud. Health Technol. Inform. 81. 322. 2001. Military medical personnel have almost no chance during peacetime to practice battlefield trauma care skills. As a result, physicians, both within and outside the Department of Defence believe that military medical personnel are not prepared to provide trauma care to the severely injured soldiers in wartime. The need for adequate training is tremendous!

14. Olinger. A. Et.al. Effectiveness of hands-on training course for laparosocopic spine surgery in a porcine model. Surg. Endosc. 13. 118, 1999

15. Pepe. PE. Copass. MK. Joyce. TH. Prehospital endotracheal intubation: rationale for training emergency medical personnel. Ann Emerg. Med. 14. 1085, 1985. Endotrachael intubation by emergency medical services personnel in the prehospital setting decreases morbidity and helps to improve the outcome of critically ill patients, especially those with cardiac or respiratory arrest, multiple injuries or severe head trauma.

16. Stuhmiller, J.H. Biological response to blast overpressure, a summary of modelling. Toxicology. 121. 91. 1997. A soldier in training is exposed to a variety of blast sources that can adversely affect his auditory and nonauditory systems. Use of modelling, simulation and data analysis to determine the nature of injury in animal models, capture that understanding in physiologically correct mathematical models and extend the findings to objective criteria that can be used to set exposure limits.

Selected Citations From Search February 13, 2007 (Alternatives)

1. Block, E.F. J. Et.al Use of a human patient simulator for the advanced trauma life support course. Am. Surg. 68. 648,2002. A highly anticipated and rewarding component of the ATLS program is the surgical skill station Logistic, societal and economic issues have results in development of human patient simulators. These investigators studied the simulator and its acceptance by participants in the ATLS program.

2. Gilbert, MK. Et. Al. A computer based trauma simulator for teaching trauma management skills. Am. J. Surg. 179. 223, 2000. The management of multiple injured trauma patients is a skill requiring broad knowledge, sound judgement and leadership capabilities. This study evaluated the effectiveness of computer based trauma simulator as a teaching tool for medical students. The simulator presentations were compared to seminar teaching groups. A significant benefit is associated with clinically based trauma management courses.

3. Kaufmann, C. Trauma training: virtual reality applicants. Stud. Health Technol. Inform. 81. 236, 2001. Training medics, medical students, nurses and residents to perform trauma care skills presents many obstacles. Training of

such personnel should be approached in a variety of ways, including virtual reality.

4. Kaufmann, C. Zakaluzny. S. Liu, A. First steps in eliminating the need for animals and cadavers in Advanced Trauma Life Support, Medical Image Computing and Computer-assisted Intervention- Miccai 2000. 1935:618. 2000. The ATLS course is designed to provide for optimal initial resuscitation of the seriously injured patient. The surgical skills component of this course requires the use of cadavers or anesthesized animals. Significantly anatomical differences and ethical issues limit the utility of animals.

5. Lee, SK. Et.al. Trauma assessment training with a patient simulator: A prospective, randomized study. Journal of Trauma-injury Infection and Critical Care, 55:651, 2003. Patient simulators are computer – controlled mannequins that may increase realism during trauma training by providing real-time changes in vital signs and physical findings during trauma scenarios. Investigations hypothesized that trauma assessment training on a patient simulator would be as effective as training with a more traditional moulage patient/actor.

6. Marshall, R.L. Et.al Use of a patients simulator in the development of resident trauma management skills. J. Trauma. 51. 17. 2001. Computerized human patient simulators have been used to improve diagnostic and therapeutic decision making. This study investigated the impact of simulator and ATLS on the development of trauma management skills and self-confidence in interns.

7. Ritter, EM. Bowyer, MW. Simulation for trauma and combat casualty care. Minimally Invasive Therapy and Allied Technologies. 14:224, 2005. Simulation applicants ranging from simple physical models to complex, computer – based virual reality systems have either been developed or are being developed to help support and improve trauma care training. Simulator are available for training in the treatment of disorders of the airway, difficulty wit breathing and problems dealing with circulation as well as various non-life-threatening but disabling injuries.

8. Spitzer. VM, Scherzinger, AL, Virtual Anatomy: An anatomist’s playground, Clinical Anatomy. 19:192, 2006. Authors feel virtual anatomy presents significant advantages over the reality of a cadaver and it provides different views and perspectives, portability and the ability of learning the living body rather than a corpse.

9. Wayne, DB. Et.al. Mastery learning of advantaged cardiac life support skills by internal medicine residents using simulation technology and deliberate practice. Journal of Internal Medicine. 21:251, 2006. Investigators used a medical simulator to assess skills of residents in ACLS scenarios.

10. Veterinary Clinics of North America. “Food and Animal Practice” Anesthesia Update Nov. 1996.

III. OBJECTIVE\HYPOTHESIS: This protocol develops the abilities of both medically trained and untrained

personnel caring for battlefield casualties or any type of catastrophic point of injury event. This project’s goal is to develop skills and techniques to deliver the most comprehensive care possible under simulated combat conditions whether it is tactical medicine in field conditions or more clinical emergency medicine using animal models to simulate human injuries.

IV. MILITARY RELEVANCE Realistic combat medical training is irreplaceable. The use of a live tissue model

facilities the participants achieving a very high level of proficiency in patient management under stressful conditions. More specifically, the participants learn to rapidly assess then manage a variety of realistically created combat wound simulations in a real time environment with immediate feedback on the efficacy of their treatment options.

V. MATERIALS AND METHODS V.1. Experimental Design and General Procedures:

The goal of this project is to facilitate participants achieving a high level of proficiency in properly managing casualties with battlefield injuries. Specific tasks will involve:

Rapid, accurate assessment of patients

Properly prioritize injuries for resuscitation

Demonstrate understanding and proficiency in proper procedures, their indications and contraindications, complications and alternatives

Demonstrate proficiency in pain management

Demonstrate proficiency in protection of casualties

Demonstrate rational use of antibiotics

Casualty evacuation

V.1.1. Experiment 1:This protocol has only one group of animals. Animals are scheduled for “on

demand” delivery. This precludes any holding of animals outside their normal area. Animals will enter stage three surgical anesthesia with 24 hours of delivery and will be killed or undergo euthanasia before recovery. The ideal is at no time should any animal feel pain. Any animal utilized in painful procedures in this protocol will have close monitoring of anesthesia to ensure anesthesia levels are maintained at the most effective levels possible. Animals shall have major, non-survival surgical procedures simulating battlefield injuries for which they will receive treatment, followed by euthanasia.

V.2. Data Analysis:

This animal use protocol requires no statistical data analysis

V.3. Laboratory Animals Required and Justification:

V.3.1 Non-animal Alternatives Considered:The goals stated in this protocol are individual and experiential and must be

learned and retained through intense, repetitive practical, hands-on experience involving direct contact with a live animal. In addition, these skills are highly perishable and must be conducted periodically to maintain a high degree of expertise.

During our last three literature searches we found no article that advanced an acceptable alternative to an animal for all of the procedures this protocol supports. Several articles reported on the use of cadavers, inanimate models such as the TruamaMan, and computers. The following are a few of the pertinent publications cited.

(a) Successful coliaborative model for trauma skills training of surgical and emergency medicine residents in a laboratory setting. (Berg.DA.et.al. Curr Surg. 2005, Nov-Dec)

(b) Simulation for trauma and combat casualty care. (Ritter, EM, Bowyer, MW. Minimally invasive therapy and allied technologies. 2005 Sept.) We believe that ATLS training is similar enough to training of veterinary students the cite the following. “The use of models and other alternatives methods should supplement, not replace, the use of live animals in the teaching curriculum” (Comparison of surgical skills of veterinary students trained using models or live animals. [Greenfield CL, Johnston AL, Schaeffer DJ, Hungerford LL: J Am Vet Med Assoc, 1995 Jun 15] ) Physicians specializing in trauma after completing a course consisting of CD-ROM and a live porcine animal laboratory concluded the following: “the operative animal session had the greatest educational benefit”. (Definitive surgical trauma care live porcine session: a technique for training in trauma surgery. (Jacobs LM, Lorenzo C, Brautigam RT; Conn Med, 2001 May)

Could the proposed study be conducted without the use of animals?

This study necessitates the use of animals. No artificial media provides an acceptable substitute. Tissue substitute materials do not provide the required tactile feedback necessary for skill-refining reinforcement training. Neither do they provide the realistic sensory feedback which delivers immediate realistic feedback to the practitioner. How will the students really know if his dressings stopped the hemorrhage or if he successfully opened the airway? Using manikins necessitates that the instructor “decide” when many procedures are complete. The student will immediately know when his lifesaving interventions are complete and can move on with his assessment or to another injured “patient”. During the clinical trauma management training this protocol supports, many of the procedures would destroy the raining aid such as amputations, tongue and liver lacerations, ad teeth removal. The use of live animals is the best means possible to produce multidimensional instruction.Non-animal alternatives considered include human role-players. This option is included in training for the benefit of intelligent, verbal feedback, patient-provider dialogue and casualty actions exceeding those of an unconscious patient. Not all injured patients are completely unresponsive as are these animal patient models. Indeed, true battlefield casualties are very verbal, animated, combative or excited in any manner or degree of physical disability. Alternatives to these protocol procedures lose variables of the tactical situation.Measures which maximize both animal use and benefit shall include, but not be limited to, the following measures:Training will integrate non-animal models, actors, mannequins and other media.Project Director will ensure participants recognize these animals are a vital resource to obtain proficiency in caring for battlefield casualties. Accordingly, participants’ actions will continually reflect the appropriate respect and care of battlefield casualties.To accurately reproduce simulated combat wounds, staff or participants may use traditional battlefield implements to wound the anesthetized animals.The effort and experience of manipulating live tissue should not be discarded.

Discerning the effort and resistance living tissue presents, staff my direct participants in the administering of wounds to anesthetized animals.No animal will be utilized in any fashion before anesthetization and all training is performed under the direct control of an instructor.

V.3.2 Animal Model and SpeciesConsideration for a lower species has been given and two species have been deemed acceptable for this protocol. Porcine (no particular strain) serve as an acceptable model for the following reasons.

Internal anatomy more closely resembles human than other available vertebrates

Resiliency of an individual maximizes use and benefit of each animal Less emotional then other vertebrates species.

Caprines (no particular strain) serve an acceptable model for the following reasons:

Ease of handling and transport, hardiness Thinner subcutaneous fat layer than the swine model Easier airway training model Size allows for instrumentation with human devices (catheters, monitoring

systems, etc.)V.3.3 Laboratory Animals No laboratory animals are to be used in this protocol

V.3.3.1. Genus & Species:See V.3.2

V.3.3.2. Strain/Stock:See V.3.2.

V.3.3.3. Source/VendorAnimals may be purchased from multiple vendor’s, however all animals will be purchased only from Class B licensed dealers. The preferred dealer for this protocol will be:Bill NicholsLic# 65-B-0115State premise ID MS 909If Mr Nichols is unable to provide his services, Global Operational Resources Group will seeks such services from another reputable class B dealer.

V.3.3.4. Age: Not applicable to this protocol

V.3.3.4. Weight:Porcine 100-150 pounds Caprine 80-90 pounds

V.3.3.6. Sex:Not applicable this protocol

V.3.3.7 Special Considerations:These animals will be delivered on demand and may be maintained NPO for a maximum of 24 hours pre-utilization. This means “nothing by mouth”, except water. This is normal pre-operative action for purposes of avoiding detrimental side effects of anesthesia such as aspirating vomit. Animals will depart from the central animal staging site to any training area only after anesthetization to minimize animal disturbance.

V.3.4. Number of Animals Required (by Species): A. Porcine (no specific strain)

ProjectYear

Animals Numbers

ApproximateWgt

Number used Simultaneously

Comments:

#1 @60 100-150 lbs 10-12 Variance depends on number of participants

#2 @75 100-150 lbs 10-12#3 @125 100-150 lbs 10-12

B. Caprine (no specific strain)

ProjectYear

Animals Numbers

ApproximateWgt

Number used Simultaneously

Comments:

#1 @50 60-90 lbs 8-10 Variance depends on number of participants

#2 @70 60-90 lbs 8-10#3 @80 60-90 lbs 8-10

V.3.5. Refinement, Reductions, Replacement (3 Rs):This animal use protocol is based on a student to animal ratio. For example in a class using a mix of porcine and caprine models, the animal use will be approximately eleven animals per twenty four students. This number is reduced when there are fewer students.

V.3.5.1. Refinement:Continual effort toward a more refined animal use is important to the administrators of this protocol. Animal husbandry such as in care and housing will be continually assessed and improved if possible. The anesthetic drug used in this project have been carefully chosen, but will be modified if newer improved drugs became available.

V.3.5.2. Reduction:A reduction in the animal use associates with this project occurs in three main areas: purchasing high quality animal from reputable class B vendors which prevents early animal depth, refinement of the anesthetic regiments which prevents sudden unexpected animal depth and insuring the instructors are trained sufficiently to maximize the life of the animal model.

V.3.5.3. Replacement:Every effort will be made to replace some, if not all, of the animal models in the future as new technology is developed to aid in the training of trauma management.

V.4. Technical Methods:

Field treatment of simulated combat injuries:General animal use method and justification:Small group instruction using Porcine modelsThe general plan is to have one instructor per six students. This may vary up to eight students depending on the class size. Each group of six will utilize two animals. Two additional animals per four groups are used for replacement purposes in case of an early animal training death. Additionally, one animal is used for the blast demonstration. If possible the blast animal will be a surviving animal from the trauma management training. The total number of animals will depend on the number of groups which varies from class to class.

Other instruction (additional Caprine models)All other instruction uses the small group instruction template to protect animal use.If the client desires more airway training, two additional animals are used per group. Generally, if two additional caprines are added to the group, one porcine is removed. This results in a total of three animals used per group of up to eight students. All surviving animals (not used in the training and teaching) will either be fed, watered and transported back to the class B vendor’s farm or sold to livestock growers.This will occur the day of training.

Specific animal use justification for field treatment:In general, tactical field live tissue training augments Tactical Combat Casualty Care or supports other tactical courses. Regardless of the class being taught, the students are divided into small groups of six or eight men. During a typical training evolution, the students generally perform the trauma management practice in groups of two with the remaining four to six members of the group observing their treatments. It takes approximately ten minutes to perform one training evolution, therefore each animal will train six evolutions in one hour. In a typical four to five hour block, each group makes twenty to thirty training evolutions depending on the skill level of the operators. Hemorrage control is the focus of the first hour. The wounding is distal to proximal to maximize animal use. By the end of this first hour, most wounding sites on the leg that will produce substantial bleeding are used up. Training will then shift to the airway, breathing, abdominal injuries and amputations. As trainers, we try to produce a mixture of injuries that will challenge and teach the client at the same time – usually attempting to have a mix of life threatening injuries along with non-life threatening injuries. For example, a non-life threatening laceration to the chest simulating a shrapnel injury along with a femoral artery laceration or a partial amputation may be used.

By experience, we have determined that the average porcine or caprine live tissue model has been used to its maximum benefit within one to one and a half hours. Most often, however, the animal expires due to blood loss or airway compromise during time frame. If the animal continues to live beyond the usual time frame, every effort is made to keep training on that animal most often by technique training such as chest tube insertions, airway training, or IV cutdowns. Once the first animal expires, it is

necropsied for addition anatomy training. Training then begins on the second animal following the same program as the first animal with the exception that the operator will begin with several different injury types simultaneously during their training evolutions instead of just focusing on hemorrhage control as with the first animal.

If the clients are advanced medically trained professionals such as Physician Assistants, or paramedics they may request extra airway training. Two caprines then usually replace one of the porcine role models. The caprines are prepped by shearing and used in virtually the same manner as the porcine model, except for much more intravenous therapy and airway training along with the hemorrhage control. These advanced medical providers are capable of running two training evolutions simultaneously – two groups of two men training at one time in each group.

The client will typically train on the following skills utilizing the live tissue model.1. Hemorrhage control (porcine/caprine)

2-5 lacerations per leg to include axillary and femoral injury1 laceration to the lateral neck – external jugular Hemostatic agent application

2. Airway control and maintainance (caprine)Insertion of Bermann or Nasopharyngeal airwaysOrotracheal intubation/blind Nasotracheal intubation Surgical cricothyroidotomy 1st through Cricothyroid membrane Subsequent airways simulated through tracheal rings

3. Breathing control and maintenance (porcine/caprine)Needle decompression Chest tube insertion

4. Circulation (intravenous therapy porcine/caprine)External jugular accessPeripheral IV accessSurgical cutdownInter-osseous access5. Abdominal trauma

Non bleeding intestinal evisceration 6. Amputations/partial amputations7. Vitals (porcine/caprine)

Heart rate and respirations8. Patient movement to cover (porcine/caprine)

The following injuries and procedures are consistent with statistical battlefield occurrences. The board recognizes the unpredictable nature of battlefield injuries and accordingly approves the following types of battlefield injuries be administrated to animals for purposes of training in casualty care:

Minor hemorhage, including superficial bleeding.Major hemorrhage, arterial and/or venous bleeding.Airway Obstruction or compromise PneumothoraxFracturesGunshot woundsBlasts, either simulated or induced

Burns Impaled objectsEviscerationsAmputations Shock

This list represents the only approved wounds for this protocol. No other injuries are authorized without prior IACUC approval. These procedures will be performed on wounds administered to animals only after animals are anesthetized. The following is a brief description of the above mentioned injuries:

Hemorrhage ControlHemorrhage on the battlefield is a common cause of preventable death which is often amendable to control with proper intervention. The ability to discriminate between life-threatening injuries needing immediate intervention and less urgent injuries is a critical skill. The art of this discrimination as well as its treatment is a perishable skill. Skilful medical care must quickly and correctly identify these and treat accordingly.

Minor hemorrhage, Including superficial bleeding.Lacerations will be made, not involving major vessels, on the extremities, trunk, abdomen or head or any combination consistent with battlefield injury. Minor lacerations do not merit advanced level training in themselves, but serve as verification of a participant’s ability to discriminate between immediately life-threatening and non-lethal injuries, thereby refining a participant’s ability to render proper and timely treatment.

Any limitation of an animal’s injury merely to life-threatening injuries alone, disallows maximization of the animal’s potential in a manner inconsistent with the spirit of the AWA. Minor lacerations may be addressed in proper priority as they are identified.

Major hemorrhage, arterial bleeding.Lacerations will be made to extremities, trunk, abdomen or head or any other combination consistent with battlefield injury. These will be produced with any suitable sharp instrument. Hemorrhage control will be accomplished by any combination of effective measures. Some common measures include tourniquets, bandages, dressings, effective use of arterial pressure points, hemostatic agents or a variety of improvised methods.

Airway ObstructionAirway obstruction may be from foreign body, such as a surgical glove, or obstructed physiologically from a displaced tongue. Teeth or other tissue or due to gunshot wound. The airway will be assessed, cleared if necessary and secured as is appropriate. Securing an airway may involve airway adjuncts, invasive procedures such as endotracheal intubation or surgical procedures such as cricothyroidotomy.

PneumothoraxChest injuries are quickly lethal when progressed to a tension pneumothorax. Vigilant observation and aggressive intervention of chest injuries are vital to patient survivability. Chest and chest wall injury will be effected via and combination of

laceration, gunshot, blast or other similar battlefield mechanism. Participants may initiate prompt decompression of pneumothorax via needle decompression, thoracotomy or other effective technique. External dressing of chest wounds should be occlusive in nature.

FracturesGiven the predominance of extremity injury, fractures occur with similar frequency. These may be closed but are more commonly open fractures which may include considerable bleeding from associated major blood vessels. Fractures may be induced in a manner consistent with battlefield injuries. Fractures will be produced mechanically with a blunt metallic object striking a long bone held suspended between two 4x4 or similar wood blocks. Fractures will be appropriately addressed after more serious life threats.

Gunshot woundsDirect fire weapons pose a definite threat on the battlefield. Recognizing the wound presentation of different calibre weapons and mounting an aggressive response to them is of paramount importance. Gunshot wounds will create wounds consistent with types and patterns of battlefield injury and shall be performed in a safe manner ensuring no participants are in the line of fire.

BlastsBlasts are a common and catastrophic feature on the modern battlefield. Blast injuries may be applied via shotgun (shrapnel simulation). Grenade, commercial or improvised explosive device to create wounds consistent with battlefield injuries. Blast injuries may result in burns, lacerations, punctures and amputations or any combination or degree of these. Blast injuries will generally be demonstrated once per class utilizing a fuel air mixture of oxygen and acetylene in a 5 gallon plastic container ignited by a squib placed on the animal’s thorax, and bleb formation on the lungs. If possible this demonstration of blast injuries and the types of injuries associated with blasts (primary, secondary, etc.) is to be done on an animal which has already been used for training to reduce our animal use numbers.

BurnsBurns are a frequent associated injury in combat, training and other routine activities of daily living. Participants must recognize the presence, degree and extent of burns as well as the patient’s physiological response to therapy. Live animals provide unmatchable modelling of these dynamics. Burns are to be produced with a portable brazing torch in a controlled environment to an animal which is in the surgical plane of anesthesia, or will be demonstrated following the blast demonstration.

Impaled objectsRecognizing the presence and associating complications of these sometimes dramatic and emotional injuries enables participants to gain confidence and proficiency in implementing proper treatment of these injuries. Objects such as sticks or metal projectiles will be simulated by first cutting a channel for the object with a scalpel or similarly sharp instrument and then placing the object within the laceration.

Eviscerations

Recognizing the presence and associated complications of these sometimes dramatic and emotional injuries enables participants to gain confidence and proficiency in implementing proper treatment of these injuries. Evisceration injuries will be produced by making a 3-5 inch laceration on the patient’s abdomen and exposing some of the intestines. Depending on the skill of the provider, a nick in a mesenteric vein or artery may be applicable for treatment options.

The following topics are approved for use or demonstration due to their benefits in teaching anatomy and physiology as relates to caring for battlefield injuries.

ShockRecognizing and discerning the signs of this dynamic physiologic response is a crucial skill for any healthcare provider. Monitoring vital signs and other indicators provides confidence in both the participant’s abilities and in proper medical procedure. In the course of the small group instruction, the instructor will discuss shock and the treatment of shock as the animals condition and vital signs change over time.

Treatment of simulated combat injuries in the clinic:General animal use method and justification:

Clinical treatment of battlefield injuries becomes increasingly important on the modern battlefield. It is central the current Tactical Combat Casualty Care course within the section of Tactical field care. This is care administered when out of direct combat or harm. Many skills used in this phase of training to further stabilize the casualty for transport are clinic in nature. Furthermore, many medical personnel are required to work in a clinical setting to maintain proficiency, therefore improving or maintaining clinical trauma management skills is of paramount importance for many levels of medical practitioners.

Generally speaking, the animals will be anesthetized by or under the supervision of a veterinarian consulting with the training. Each group will receive one (or two animals depending on the training desired). The training will be conducted in an area with suitable lights and tables to support the animal model.

Specific animal use justification for clinical teaching/training:This training may or may not follow care under fore training. If it follows the above mentioned training every effort will be used to utilize the same patients from the tactical field training. The veterinarian or his representative will insure all animals are properly anesthetized at all times. This clinical training may be taught as a standalone course to provide invaluable emergency medical treatment sustainment training for advanced medical practitioners.

This training is conducted in a small group environment with one instructor per four to eight men. Each group will utilize one porcine or caprine model. If the client or student wishes more airway training, an additional caprine may be added. This will result in two animals per up to eight men.

The training will progress for up to eight hours and will encompass the following skills and tasks which will always be performed under the supervision of medically

qualified personnel. The following list serves to identify common procedures in an emergency clinical setting – not all procedures will be performed (depending on equipment availability) and they may be altered by the medical professionals supervising the course.

Lab Part 1 – Initial Procedures:

1. Spray the larynx generously with lidocaine. Perform a needle cricothyroidotomy and retrograde intubation of the subject OR perform a surgical cricothyroidotomy and place an ETT (endotracheal tube). GENTLY hyperventilate the subject with room air. Remove the ETT and repeat until all students have achieved successful retrograde intubation. Leave the last ETT in place and secure.

2. GENTLY ventilate your patient at least 1 min every 5, or anytime to the SaO2 (O2 saturation) is below 90%.

3. (Optional) Place an improvised CVP (central venous pressure) line & record data with your vitals.

4. Examine your patient & obtain baseline vital signs. Monitor BP (blood pressure), Pulse, respirations, rectal temp, fluids in, urine output and periodically SaO2. Check these every 15 min when stable and nearly continuously when not. Record on your log sheet.

5. Place a nasogastic tube and urinary catheter – use a collection bag on the later & document urine with vitals.

6. (Optional) Place an I/O (intra osseous) line in the limb or your choice & hang a bag of IV (intra venous) fluid. Pressure infuse if needed to maintain a TKO (to keep open) line. Do not infuse large amounts of fluid. Depending on the subjects size you may be able to use the humerus or femur. This will be the student IV line along with any others that may be placed in the course of the exercise.

7. Conduct a digital rectal and anoscope exam. Obtain some stool, place in a syringe and dilute with saline, inject into your I/O line to stimulate a sepsis response. Place a rectal decompression tube.

8. Occlude the ETT and monitor & record the vitals until the subject is tachycardic and hypoxic. This is a test for the level of anesthesthia as well as providing base line shock vitals for you subject.

9. Lab Part 2 – Orthapedics &Soft Tissue Procedures:10. Identify a major joint space, aspirate synovial fluid, remove the syringe and

add 1 ml of water to the syringe. Inject the joint.11. (Optional) Identify the distal humerus or femur. Place a Steinman pin &

establish a traction system. Take down the traction but leave the pin in place.12. Identify the ‘Wrist’ & ‘Ankle’ of the subject. Identify a large tendon through

palpation or incision, partially lacerate & suture the tendon. Then completely lacerate & suture the tendon. Then apply a tourniquet and perform a standard disarticulation amputation & conduct a multilevel stump closure with drain. Give careful attention to bleeding control.

13. Conduct a mid shaft amputation with bone debridement, multilevel stump closure with drain. Give careful attention to bleeding control. Don’t amputate your I/O.

14. Perform a fasciotomy on your limb. Control bleeding.

15. Practice suturing if you like on the thinner inner skin of the axillia & groin. Depending on the skin thickness of your subject you may be able to perform flaps, grafts, and similar procedures.

16. Lab part 3 – Abdominal, EENT (eye, ear, nose throat) & Dental procedures:

17. Palpate the liver, spleen and pubic symphasis.18. If a significant amount of urine has collected from the catheter, elevate the bag

and fill the bladder. If not, put 250 ml of water in the collection bag and fill the bladder. Account for any urine/water removed in your urine output log. Perform a suprapubic tap procedure.

19. Conduct a peritoneal lavage procedure.20. Working as a team, make a damage control laparotomy incision. Identify the

liver, stomach, spleen, pancreas, small & large intestine. Conduct a damage control survey of the 6 quadrants & gutters. Run the bowel from the top to bottom.

21. Place an intraperitioneal drain in the quadrant of your choice.22. Taking turns, a) make a small (2cm) laceration to the liver, pack it and

oversew the packing using improvised liver pledgets; b) identify and ligate the splenic vessels – remove the ligation when done, unless you tear a vessel, I n which case leave in place; c) lacerate the small intestine & repair, repeat with the large intestine.

23. Ligate the large intestine on either side of your repair. Convert this to a simple loop colostomy. Convert this to a double colostomy if you have time.

24. Working as a team, close the abdominal cavity with the improvised method of your choice.

25. Simultaneously with the above, while waiting your turn for space and procedures, a) sew and remove the sutures from an eyelid, and sew the eyelids together & remove: b) make a small injury to the comea, stain, and examine: c) place stay sutures and sew tongue lacerations: d) conduct any dental procedures especially drilling that the chief instructor OKs: e) sew auricular hematoma pledgets.

26. Lab part 4 – Shock Physiology & Resusitation:27. Perform a venous cut down and place a large bone (14 or 16 ga catheter if

possible) and attached to a blood collecting bag or empty IV bag with Heparin added.

28. Induce a tension pneumothorax on the right side by injecting air in 100 ml increments, checking the vitals after each injection. Stop when the subject is tachycardic & hypoxic.

29. Relieve the tension by needle decompression. Gently hyperventilate the subject until it reyurns.

30. Repeat the above until everyone on the team who desires to has performed the needle decompression.

31. As a team, lacerate a temoral artery. Observe the typical arterial spurt. Take turns applying deep packing & dorect pressure.

32. Apply Celox or Quick clot (you will be assigned one or the other) to the bleeding & observe the effect. Wash out the wound until rebleeding occurs. Clamp the artery & ligate. Deep pack & dress the wound. Repeat vital signs immediately.

33. If the subject is tachycardic and hypotensive, or the CVP is <5, bolus with 250 ml of Normal Saline through your I/O line & observe. If not, aloe

approximately 250ml of blood to drain into the blood collection bag and recheck. Repeat until the subject is in moderate shock and then give 250 ml Normal Saline bolus & observe. Repeat until the subject returns to baseline.

34. Drain 250 ml units of blood into the collection bag until the subject is again in moderate shock. Mix 250 ml of 7% hypertonic saline, bolus and observe. Repeat until the subject returns to baseline.

35. Drain 250 ml units of blood into the collection bag until the subject is again in moderate shock. Mix 400mg of Dopamine in 250 ml of Normal Saline and piggy back onto your I/O line. Start at 5 mcg/kg/min and titrate by 5 every 10 minute until the subject is normotensive or your reach 15 mcg/kg/min. Observe the result. Stop the drip and observe the results.

36. Drain 250 ml units of blood into the collection bag until the subject is again in moderate shock. Administer the collected blood to the patient & observe/

37. Lab Part 5 – Thoracic Procedures:38. Make a 2 cm intercostal incision on the right side. Observe the effect. Place a

‘sucking chest wound’ type dressing over the wound and observe the effect. Inject 100 ml of air and observe the effect.

39. Place a chest tube on the right side & observe. Apply suction to the chest tube and observe. Repeat on the left side and observe. As the subject decompensates you will have to begin continuous ventilation with the BVM (bag valve mask).

40. Remove the chest tubes and allow the other students to place theirs.41. Perform a thoracotomy on the left side and observe the lung function with

ventilation. You may need to release a rib or two from the sternum. Puncture the lung and observe the effect.

42. Perform a thoracotomy on the left side and observe the heart function. Again you may need to release a rib or two. Identify the pericardium, lift with pick-ups and inject water until the sack is tense. Observe the effect of the tamponade.

43. Window the pericardium and observe the effect of the release of the tamponade.

44. Take turns puncturing the heart with an ice pick and over-sewing a pledget onto the myocardium wound.

45. Lab Part 6 – Concluding Procedures.46. Organectomies, arterial bleeds, and additional skin surgery are valid examples

of approved concluding procedures. All students will consult the Medical Doctor prior to performing any unscheduled training.

47. Remove the ETT and take turns placing a surgical cricothyroidotomy (or tracheostomy as you move down the airway)

48. If your subject is still viable, call the veterinarian or their designated representative to euthanize the animal according to the procedure outlined in this protocol.

49. Working as a team, enucleate both eyes, sequester the optic nerves and suture the lids.

50. Working as a team, place cranial burr holes. Strike the burr holes with a hammer to produce a depressed open fracture. Practice removal of bone fragments and elevation of depressed segments.

Animal injuries shall be introduced in a manner maximizing the benefit wrought from the animal. Maximize learning from each animal shall be obtained before animal undergoes euthanasia.

Participants will consider animals as battlefield casualties and treat accordingly. Nothing in this protocol should be interpreted as limiting the benefit of the animal as long as the action does not result in any stress or pain to the animal, or does not violate the protocol restriction nor violate the spirit of the Animal Welfare Act. The IACUC finds no benefit or value in animal executions. Each animal use will be maximized.This protocol strives to ensure animals fell no pain. Any painful procedures will be closely monitored for maximum effective anesthesia. No procedure will be administrated to any animal prior to anesthetization except for preparatory procedures such as shearing.

V.4.1 Pain / Distress AssessmentsProjects Directors must consider alternatives to procedures that may cause more than momentary or slight pain or distress.

The law defines “pain procedure” as any procedure that would reasonably be expected to cause more than slight or momentary pain or distress in a human being to which that procedure was applied “accordingly, although this protocol describes and endorses surgical procedures, this protocol intends no painful experiences. The animals will receive an initial sedative injection to initiate anesthesia. Anesthesia shall then be maintained continuously through euthanasia.

V.4.1.1. APHIS Form 7023 Information:

A. Procedures on most invertebrates or on live tissue isolates. Examples include the use to tissue culture or tissues obtained at necropsy.

B. Procedures which cause little or no discomfort or stress. Examples include domestic flocks or herds being maintained in actual commercial production; the short-term restraint of animals for purposes of observation or physical examination, blood sampling or injection of materials that do not cause adverse reactions.

C. Procedures which cause minor stress or pain of short duration. Examples include cannulation or catheterization of blood vessels or body cavities under anesthesia, minor surgical procedures such as biopsies, short periods of restraint beyond that for simple observation but consistent with minimal distress.

D. Procedures which cause moderate to severe distress or discomfort. Possible examples include major surgical procedures under general anesthesia, with subsequent recovery: prolonged (several hours) periods of physical restraint, induction of anatomical and physiological abnormalities that will result in pain or distress.

Note: Procedures used in category D studies should not cause prolonged or severe clinical distress as may be exhibited by vocalization, withdrawal or bulbar reflex. This protocol does not intent recovery from anesthesia.

E. Procedures which cause severe pain near, at, or above the pain tolerance threshold of unanesthetized conscious animals: Possible examples include surgical procedures, exposure to stimuli that markedly impair physiological systems and which can cause death, severe pain or extreme distress on unanesthetized animals.

V.4.1.1.1. Number of Animals:

Species #1 (Swine) Species #2 (Caprine)V.4.1.1.1.1. Column C: n/a n/aV.4.1.1.1.2. Column D: All planned for this All planned for this

column columnV.4.1.1.1.3. Column E: n/a n/a

V.4.1.2. Pain Relief/PreventionSee section V.4.1.2.1

V.4.1.2.1. Anesthesia/Analgesia/Tranquillization:List: The attending veterinarian recommends the following agents for anesthetizing members of the species noted. The following is a list of anesthetic agents and their concentration. In some instances it may be necessary to alter the drug and/or dosage to insure the desired anesthetization.

Porcine Anesthesia regime #1Ketamine (ketaset) (40 mg/ml)Xylazine (Rompun) (20 mg/ml)Pentobarbitol (390 mg/ml)Morphine (15mg/ml)Butorphanol (10mg/ml)Diazepam (10mg/ml)Draw one 30 ml syringe with Ketamine 5 mg/kg, Xylazine 2 mg/kg. Butorphanol 0.2 mg/kg, Diazepam 1 mg/kg, Atropine 0.04 mg/kg. For a 50 kg subject this would = 2.5 ml Ketamine. 1 ml Xylazine, 5 ml Butorphanol, Diazepam 10 ml, Atropine 5 ml. Inject DEEP IM (intra muscular) ¼ of the syringe in each 4 flank muscles to minimize the discomfort of a large volume of medication in a single site and enhance rapid onset. Wait 15 minutes for sufficient anesthesia and place a jugular line or peripheral IV access/cutdown. Anesthesia will be maintained via IV access at the ear, jugular or other IV site. Cannulate the central ear vein on the back of the ear with 24 ga 1.5* jelco (or butterfly) or larger & stitch in place. If you cannot achieve an IV here your instructor/vet will assist you with various cut-down sites. Run the line at TKO (to keep open).Maintain the surgical plane with a bolus via slow IVP (intra venous push) Ketamine 0.5 mg/kg, Xylazine 0.25 mg/kg. Diazepam 1 mg/kg. Repeat as needed to maintain surgical anesthesia. If IV access is lost, utilize the initial IM injection cocktail PRN to maintain sufficient patient anesthesia/analgesia to continue the training.

It will be titrated to maintain a sufficient anesthetic plane to produce wounds per this protocol with no patient movement/pain as evidenced by muscle/jaw laxity.

Pain will be managed with Morphine (15 mg/ml) titrated for effect administrated IV or Butorphanol 0.2 mg/kg IV/IM PRN (as needed) or every4 hoursPentobarbitol (390 mg/ml) may be used to maintain anesthesia and will be administrated IV PR.Diazepam 5 mg IV every 30 min PRN for muscle relaxationAtropine 0.04 mg/kg IV/IM may be used for bradycardias or hyper salivation.

Caprine Anesthesia regime #1

Ketamine (Ketaset) (40 mg/ml)Xylazine (Rompun) (1mg/ml)Diazepam (Valium) (1 mg/ml)Acepromazine (2mg/ml)

Morphine (15 mg/ml)

The Ketamine, xylazine, diazepam and acepromazine are mixed as a cocktail and administered IV at the rate of 1 ml per 50 KG of animal weight. The drugs are mixed 2:1:1:1 with the Ketamine at 2 times the volume of the other drugs in the cocktail. This is administered IV and will be titrated to maintain a sufficient anesthetic plane.

CAUTION, KNOW THE CONCENTRATION OF YOUR XYLAZINE: If the concentration of xylazine (Rompun) is stronger (i.e. 100 mg/ml) then the total amount of xylazine will remain the same, yet the volume will decrease.

V.4.1.2.2. Pre – and –Post procedural (not surgery) Provisions:All animals are to be kept NPO for 24 hours before any surgical anesthesia. The animals are to kept in housing suitable to their species and will not be housed more than 24 hours.

V.4.1.2.3. ParalyticsNo paralytics are to be used in this project.

V.4.1.3. Literature Search for Alternatives to Painful or Distress Procedures:

V.4.1.3.1. Sources Searched:See section 11.2.3

V.4.1.3.2. Date of Search:13FEB2007 20MAY2008

V.4.1.3.3. Period of Search:1998 to present (2007)

V.4.1.3.4. Key Words of Search:Multiple key word searches were conducted to answer the questions:Is the conduct of the ATLS animal laboratory justified?Is the use of animals in surgical training justified?

Are there any available alternatives to the use of animals in ATLS practicums or surgical training?

V.4.1.3.5. Results of Search:See section 11.2.5

V.4.1.4. Unalleviated Painful or Distressful Procedure Justification:Not applicable to this project

V.4.2. Prolonged Restraint:No prolonged restraint will be used or authorized.

V.4.3. Surgery:Major Survival Surgery – Any surgical intervention that penetrates and exposes a body cavity, any procedure that has the potential for inducing permanent physical or physiologic impairment, and/or any procedure associated with orthopedicsor extensive tissue dissection or transaction.

Minor Survival Surgery – Any surgical intervention that does not expose a body cavity and causes little or no physical impairment. Examples include laparoscopy, wound suturing, peripheral vessel cannulation, percutaneous biopsy, routine farm-animal procedures such as dehorning, castration, prolapse repair and most procedures done on an “outpatient” basis in veterinary clinical practice.

Multiple Survival Surgery – Animal recovers from initial surgery (major and/or minor) and is subsequently reanesthetized for one or more survival surgical procedures (major and/or minor) related to this study. NOTE. No animal may be used in more than one MAJOR operative procedure from which it is allowed to recover. Unless, 1) justified for scientific reasons, 2) required as routine veterinary procedure or to protect the health or well-being of the animal, or 3) other special corcumstances as determined by the Administrator, APHIS, USDA (Animal and plant Health Inspection Service, United State Department of Agriculture).Note: This protocol includes no recovery after anesthesia as well as no Survival Surgery. Animals will not be recovered from any procedure once anesthetized.

V.4.3.1. Pre – surgical Provisions:All animals are to be kept NPO for 24 hours before any surgical anesthesia. The animals are to be kept in housing suitable to their species. All animals will be scheduled to be delivered “on demand” and will not be housed more than 24 hours on the project site.The animals will be inspected by the veterinarian upon arrival to the training area to determine the animal’s suitably for the program. Conditions which preclude use include but are not limited to the following: disease, sickness, pregnancy, size (see V.3.4) Once training begins, the veterinarian or designated representative will anesthetize and begin the documentation process for each animal.

V.4.3.2. Procedure:See section V.4

V.4.3.3. Post – surgical Provisions:

This protocol includes no recovery after anesthesia as well as no Survival Surgery. Animals will not be recovered from any procedure once anesthetized.

V.4.3.4. Location:The primary training facilities are located at Olive training center in Arkansas, the PEAK in Montana and Hawthorne Army Depot in Nevada. Given the protocol requirements, any site inspected and approved by the IACUC may be utilized. Training will begin at the center animal staging site (identified by the program director) and progress throughout the training facility.

NOTE: Animals may NOT be held in a facility overnight without IACUC approval. In cases where overnight housing may be approved, a written supplement to the Animal Care and use Protocol must be developed following all applicable USDA Animal Welfare Act and animal Welfare Regulations.

V.4.3.5. Surgeons:This protocol requires no surgeon. However, if clinical trauma management skills are being trained, appropriate medical professionals (Medical Doctor or Doctor of Osteopathy) will direct and supervise the training. Otherwise, the veterinarian and his assistants, or representative will place all jugular catheters. Each instructor receives training in animal wounding per this protocol.

V.4.3.6. Multiple Major Survival Operative Procedures:There are no major multiple survival operative procedures in this protocol.

V.4.3.6.1. Procedures:See section V.4

V.4.3.6.2. Scientific Justifications:See section 11.2.5

V.4.4. Animal Manipulations:See section V.4

V.4.4.1. Injections:Agent

a. Ketamine (ketaset) Anesthesia/analgesia 100mg/ml IM/IVb. Xylazine (Rompun) Anesthesia/analgesia 20 mg/ml IM/IVc. Diazepam (Valium) Sedative 1 mg/ml IVd. Acepromazine Sedative 2 mg/ml IVe. Morphine Analgesia 15 mg/ml IM/IVf. Pentobarbitol Anesthesia/Euthanasia 390mg/ml IVg. Butorphanol Analgesia 10mg/ml IM/IV

Euthanasia, Pentobarbitol (390mg/ml) administered intravenously, at the rate os 1 ml/10 lbs body weight.

Regimen for the use of these agents – Se e section V.4.1.2.1.

Euthanasia technique

Pentobarbitol 390 mg/ml IV @ 1 ml/10 lbs body weight. Any variance from the recommendations for euthanasia contained in the 1993 AVMA Guidelines must be justified. Euthanasia will be carried out by veterinarian or their designated representative.

V.4.4.2. Biosamples:Not applicable to this project

V.4.4.3. Adjuvants:Not applicable to this project

V.4.4.4. Monoclonal Antibody (MAbs) Production:Not applicable to this project

V.4.4.5. Animals Identification:Given the short duration of the individual training evolution (less than 8 hours), the animals will either be numbered with an indelible marker, or have an ear tag placed into the ear.

V.4.4.6. Behaviour Studies;Not applicable to this project

V.4.4.7. Other Procedures:Not applicable to this project

V.4.4.8. Tissue Sharing:Not applicable to this project

V.4.5. Study Endpoint:This is a protocol supporting animal use in the conduct of trauma management training and is therefore theoretically without an endpoint. The protocol will be reviewed yearly by the IACUC committee to determine its continued viability for teaching, not only in content but with regard for the three R’s (refinement, reduction, replacement).

V.4.6. Euthanasia:See section V.4.4.1

V.5. Veterinary Care:All veterinary care will be administered by state licensed veterinarians. The attending veterinarian/consulting veterinarian will use APHIS form 7002 as a guideline for care administered to the animals used in this project.

V.5.1. Husbandry Considerations:All veterinary care will be administered by state licensed veterinarians. The attending veterinarian will set policy and guidelines and the consulting vet(s) will implement

said policies such as anesthesia regimens and euthanasia regimens at the training facilities.

V.5.1.1 Study Room:Not applicable to this project. See section V.4.3.4.

V.5.1.2. Special Husbandry Provisions:See section V.3.3.7.

Food Restriction: Yes ______ No______Fluid Restriction: Yes ______ No______

V.5.1.3. Exceptions:The animals used in this project may not be placed NPO 24 hours prior to use

V.5.2. Veterinary Medical Care:All veterinary care will be administered by state licensed veterinarians. The attending vet/consulting vet will use APHIS form 7002 as a guideline for care administered to the animals used in this project.

V.5.2.1. Routine Veterinary Medical Care:Animals used in this protocol are delivered the day of use. All veterinary care either routine or emergency will be carried out by the veterinarian.

V.5.2.2. Emergency Veterinary Medical Care:Animals used in this protocol are delivered the day of use. All veterinary care either routine or emergency will be carried out by the consulting veterinarian.

V.5.3. Environmental Enrichment:All animals used in this project are scheduled for delivery the day of use. All species will be maintained in housing suitable for their species with regards to heating/cooling and availability to water and food (if not NPO), and shade.V.5.3.1. Enrichment Strategy:All animals associated with this project will be kept as comfortable and undisturbed as possible, therefore at a minimum the following will be observed by project participants at all times:Manipulation will be minimizedAnimals shall not be unnecessarily moved between sites.Animals shall not be separated from the herd except to induce or after anesthetization.Animals shall not be collocated or within eyesight of carcasses.Animals shall not be unnecessarily exposed to disturbing noises.Animals shall not be within direct eyesight of procedures.Animals shall not be exposed to unnecessary human contact.Animals will not be species comingled.

V.5.3.2. Enrichment Restrictions:Not applicable this protocol

VI. STUDY PERSONNEL QUALIFICATIONS AN TRAINING

Federal law requires that personnel conducting procedures on the species proposed must be appropriately qualified and trained. Any persons conducting procedures will receive an in-brief before conducting interaction with animals as well as sustainment training to refine their use of animals. All IACUC members and protocols signers will receive bi-annual training developed/guided by the IACUC chair or suitable representative in responsible animal use. This training should, at a minimum include learning directed towards refining. Reducing and replacing the number of animals.

The project directors and attending veterinarian for this protocol must have experience in conducting this type of medical activity as well as knowledge of the species used.

See page 3 – Individuals associated with teaching and research or supervising this protocol.

VI. BIOHAZARDS/SAFETY VII.1. Will animals be exposed to vivo hazardous agents?

Yes______ No______2. Will animals be housed following exposure to hazardous agents?

Yes______ No______

A. HAZARDOUS CHEICALSSee attached MSDS sheets

( )Carcinogens, mutagens, teratogensList:_________________________________________________________________( )NeurotoxonsList__________________________________________________________________( ) Anesthetic Gases/VaporsList__________________________________________________________________( )Investigational drugs (those without FDA approval for human use)List__________________________________________________________________( )Other Chemical ToxinsList__________________________________________________________________

B. BIOLOGICAL HAZARDS (NONE)

( )Biological agents (viral, bacterial and fungal organisms or human/animal parasites) List__________________________________________________________________( )Biological Toxins or ProductsList__________________________________________________________________( ) Human Blood, Blood Products, Tissues, or Cell LinesList__________________________________________________________________( )Recombinant DNA (plasmids, genes, vectors)List__________________________________________________________________( )Transgenic Animals( )Animal productionPlease specify:

_____________________________________________________________________( )Animal production off-site or commercially Please specify_____________________________________________________________________( )Other BiohazardsList__________________________________________________________________

C. RADIATION HAZARDS (NONE)

( )Radioactive Material (radioisotopes or tracers)List__________________________________________________________________( )Radiation (inadiator, X-Ray Machines, Densitometry)List__________________________________________________________________Location Used_________________________________________________________( )Lasers List__________________________________________________________________Location Used_________________________________________________________

3. Will animals or animal tissue be exposed to controlled substances?Yes______ No______

See Section V.4.4.1.

VIII. ENCLOSURES:MSDA sheetsAnimal Use SOP

IX ASSURANCES:

ASSURANCES: The law specifically requires several written assurances from the Principal Investigator. Please read and sign the assurances as indicated.

As the Principal Investigator on this protocol, I acknowledge my responsibilities and provide assurances for the following;

A. Animal Use: The animals authorized for use in the protocol will be used only in the activities and in the manner described herein, unless a modification is specifically approved by the IACUC prior to its implementation.

B. Duplication of Effort. I have made every effort to ensure that this protocol is not unnecessary duplication of pervious experiments.

C. Statistical Assurance: I assure that I have consulted with a qualified individual who evaluated the experimental design with respect to the statistical analysis and that the minimum number of animals needed for scientific validity will be used.

D. Biohazard/Safety: I have taken into consideration and made the proper coordination regarding all applicable rules and regulations concerning radiation protection, bio-safety, hazardous materials and so forth, in the preparation of this protocol.

E. Training: I verify that the personnel performing the animal procedures/manipulations/observations described in this protocol are

technically competent and have properly trained to ensure that no unnecessary pain or distress will be caused to the animals as a result of the procedures/manipulations.

F. Responsibility: I acknowledge the inherent moral, athical and administrative obligations associated with the performance of this animals use protocol and I assure that all individuals associated with this project will demonstrate a concern for health, comfort, welfare and well being of the research animals. Additionally, I pledge to conduct this study in the spirit of the forth “R” namely “Responsibility” which Global Operational Resources Group has embraced for implementing animal use alternatives where feasible and conducting humane and lawful research or training.

G. Scientific Reviewer: This proposed animal use protocol has received approval peer scientific review and is consistent with good scientific research practice.

H. Painful Procedures: (A signature for this assurance is required by the Principal Investigator if the research being conducted has the potential to cause more than momentary or slight pain or distress even if an anesthetic or analgesic is used to relieve the pain and/or distress.)

I am conducting biomedical training which may potentially cause more than momentary or slight pain or distress to animals. This potential pain and/or distress WILL or WILL NOT (circle one or both, if applicable) be relieved with the use of anesthetics, analgesics, and/or tranquillizers. I have considered alternatives to such procedures; however, I have determined that alternative procedures are not available to accomplish the objectives of this proposed endeavour.

Daniel Elissalde, 18D, Director/Principal Investigator

Signature Date

X. PROTOCOLS ABSTACT:

A. Animal Protocol Number: GOR –Educational Protocol A

B. Animal Protocol Title: Field and Clinic Treatment of Simulated Combat Trauma

C. Principal Investigator: Daniel Elissalde 501-773-8776

D. Performing Organization: Global Operational Resources Group, Inc.

E. Funding: Not applicable

F. Objective and ApproachThis protocol develops the abilities of both medically trained and untrained

personnel caring for battlefield casualties or any type of catastrophic point of injury event. This project’s goal is to develop skills and techniques to deliver the

most comprehensive care possible under simulated combat conditions using animal models to simulate human injuries.

Combat injury types and distribution are well documented. Battlefield medicine is conducted under extremely non-ideal conditions. Tactical situations often force contradictory choices between good medicine and good tactics. “Good medicine is often bad tactics and bad tactics can get everyone killed”. This protocol supports training for these hard decisions. Training to find the balance between medicine and tactics increases the everyone’s survivability – both the patient and the care giver.

The administrators of this protocol have chosen both porcine and caprine models for the following reasons:Porcine (no particular strain) serve as an acceptable model for the following reasons:

Internal anatomy more closely resembles human than other available vertebrates

Resiliency of an individual maximizes use and benefit of each animal Less emotion than other vertebrate species

Caprines (no particular strain) serve as an acceptable model for the following reasons: Ease of handling and transport, hardiness Thinner subcutaneous fat layer than the swine model Easier airway training model Size allows for instrumentation with human devices (catheters,

monitoring systems, etc)

The following injuries and procedures are consistent with statistical battlefield occurrences. The board recognizes the unpredictable nature of battlefield injuries and accordingly approves the following types of battlefield injuries be administrated to animals for purposes of training in casualty care:

Minor hemorrhage, including superficial bleeding.Major hemorrhage, arterial and/or venous bleeding.Airway Obstruction or compromise.Pneumothorax Fractures Gunshot woundsBlasts, either simulated or inducedBurnsImpaled objectsEviscerationsAmputationsShock

See Section V.4 for more detailed methodology

This protocol is based on the 3 R’s (refine, reduce and replace). All team members who train with the animals will continually refines their practice and skills according to the tenets of this protocol. Accordingly the IACUC is committed to bi-annual training which focuses on the 3 R’s and will search for methods to reduce and or replace animal numbers at each training session.

G Indexing Terms (Descriptions):ATLSAnimalsPorcineSwineHogPigCaprineGoatMinor hemorrhage, including superficial bleedingMajor hemorrhage, arterial and/or venous bleedingAirway Obstruction or compromisePneumothoraxGunshot woundsBlasts, either simulated or inducedBurnsImpaled objectsEviscerations AmputationsShock Ketamine (Ketaset)ButorphanolXylazine (Rompun)Diazepam (Valium)AcepromazineMorphinePentobarbital