peel/halton 2010 cme sheldon cheskes, md ccfp(em) fcfp medical director sunnybrook – osler centre...
TRANSCRIPT
Peel/Halton 2010 CME
Sheldon Cheskes, MD CCFP(EM) FCFPMedical Director
Sunnybrook – Osler Centre for Prehospital CareLi Ka Shing Knowledge Institute, St. Michael’s Hospital
Co Principal Investigator, Resuscitation Outcomes Consortium, Toronto Regional Rescuenet
Resuscitation Outcomes Consortium (ROC)
What Studies Are Coming Down The Pike?
Previous Trials
ROC Epistry: Cardiac Arrest Data Base ROC PRIMED: Early Vs Late Analysis and
use of ITD ROC HS: Hypertonic Saline in TBI and
Hypovolemic Shock
EMS Providers Views
Enjoy taking part in randomized controlled trials “Lots of work” “Pain in the @@#%” Challenges of randomization, documentation,
and CPR process capture
Overwhelming View
Despite findings of previous ROC RCT “Thirst for a positive trial”
What's Next For ROC EMS Agencies
Cardiac Trials ROC CCC ROC Amiodarone
Trauma Trials ROC Lactate ROC Hypotensive Resuscitation
Upcoming Trial Overview
Science Methodology EMS Challenges
ROC CCC
Trial of Continuous Compressions vs Standard CPR in patient’s with out-
of-hospital cardiac arrest
ROC CCC Science Greater coronary perfusion pressure
associated with greater ROSC in animal and human studies
Interruptions in chest compression reduce CPP
Observational studies suggest at least as effective as standard CPR
Observational trials instituted multiple changes? Impact of CCC
ROC CCC Science
Insertion of advanced airway associated with interruption in CPR
CCF (hands on time) increased in sites using CCC model
Increased CCF associated with increased survival from VF/VT
ROC CCC Methodology
EMS arrival at patient (>18, non –traumatic cardiac arrest, lack of exclusion criteria) with randomization to:
Control group3 cycles of 2 minutes of standard
(30:2) CPRanalysis after each 2 minute CPR
cyclestandard site ventilatory treatment
ROC CCC Methodology
Randomization Group:3 cycles of 2 minutes of CPR using
continuous compressions with no stops for ventilation
Analysis after each 2 minute CPR cycle
ROC CCC Methodology
Ventilation Strategy In Randomization Group: Sites will choose between two ventilation
strategies
Positive pressure ventilation 10 ventilations/minute via BVM with no
CPR interruptions for ventilations
Passive ventilation Oral airway with oxygen via non re-
breather at 15 l/min
ROC CCC MethodologyBoth Groups:
IV or IO with epinephrine or vasopressin given within 5 minutes of ALS arrival
After advanced airway inserted ventilation rate at 10/minute compression rate at 100/minute (current standard) until ROSC or termination of resuscitation
ROC CCC EMS Challenges Maximize CPR process files*** Randomization: cluster and frequency of
cross over ALS medics not intubating for first five
minutes Supraglottic airways: advanced or not? Bagging while doing compressions in
unprotected airway
ROC Amiodarone
Amiodarone (pm101), lidocaine or neither for out-of-hospital cardiac
arrest due to ventricular fibrillation or tachycardia
ROC Amiodarone Science
Little evidence that anti-arrythmics have any impact on survival from OHCA
Given lack of evidence question is not just which anti-arrythmic should be used but should any be used?
Since no evidence of improvement in survival to discharge inclusion of placebo arm is required
ROC Amiodarone Science Three staged model of cardiac arrest Antiarrythmics necessary to correct
electrical abnormalities Previous trials of antiarrythmics delayed
administration until well into metabolic phase
Optimal approach would be administration during electrical or circulatory phase
ROC Amiodarone Science
ALIVE: amiodarone recipients more likely to survive to hospital
ARREST: similar results to ALIVE Neither trial designed or powered to evaluate
survival to discharge Occurred in era of “poor CPR” (stacked shocks,
shock pauses of greater length, pulse checks) Late amiodarone! (given 21-25 after call
received, given 10 minutes after IV established)
ROC Amiodarone ScienceAmiodarone the drug
Amio insoluble in water, polysorbate 80 used as diluent
Makes amio difficult to deliver, drawn up from glass ampules then diluted before use
Tends to foam due to diluent Incompatible with solutions other then
D5W Diluent (as opposed to drug) causes
hypotension and phlebitis
ROC Amiodarone Science
Captisol-enabled amiodarone (pm101) New FDA approved formulation using
diluent (captisol) Diluent clear, hemo and electro inert Compatible with solutions other then D5W does not absorb in plastic pre filled syringe IV push immediately after IV established
ROC Amiodarone Methodology
Confirmed non traumatic cardiac arrest BLS CPR, analysis, shock and IV/IO
established After 1st shock**, CPR established,
vasopressor flush, study drug x 2 flush while ongoing CPR
2nd analysis if shockable> shock, CPR, advanced airway, vasopressor
3rd analysis if shockable> shock, CPR, study drug x1
ROC Amiodarone Methodology
Study Drug Kit Contents
ROC Amiodarone MethodologyRationale for lack of Rescue arm for
persistent VF/VT
Further open label doses may risk toxicity Require un-blinding in field (difficult) Neither study drug class 1 recommendation No preclusion to other treatments (EPI,
MAG, B Blocker, etc) Cross-over makes analysis more difficult
ROC Amiodarone EMS Challenges
Timing of Amiodarone delivery (voice, defib, guess!)
Tracking study kits, (remember ITDs!) Randomization Focus on early administration (new
approach to delivery) Local REB > will they allow a placebo
arm?
ROC Lactate
Prehospital lactate for the identification of shock in trauma
ROC Lactate Science
Recent prospective out-of-hospital research suggest HR and hypotension poor predictors of need for intervention in trauma
Hypotension late finding Delayed identification of hypo-perfusion
results in delayed definitive care
ROC Lactate Science Lactate biomarker of organ oxygen
supply/demand mismatch Elevated in sepsis, MI, trauma Historically only measured in hospital Now available point of care (POC) testing
of lactate level in prehospital care To date lactate testing predicts severity of
hemorrhage, mortality and need for ICU admission
ROC Lactate Science
Can POC testing be used as a triage tool?
Can we predict patients who will need resuscitative care that would not have been predicted otherwise?
ROC Lactate Methodology
Prospective observational study to identify patients suffering from hypo-perfusion secondary to trauma
Included patients meet local TT guidelines: BP < 100, Transported to level 1 or 2 trauma center Died in field or en route
Exclusions >isolated penetrating head injury
ROC Lactate Methodology
Patient identified, IV established, 50 micro liter (drop of blood) applied to POC lactate meter (similar to glucometer)
EMS blinded to result until reach ER No change in EMS treatment based on
POC testing Second lactate to be drawn in ER
ROC Lactate Methodology
ROC Lactate Meter
ROC Lactate EMS Challenges Pure ALS trial Need for trauma center transport Accurate documentation of lactate time of
draw Will medics un-blind and alter treatment? POC calibration POC tracking Blood sample after IV as opposed to
before
ROC Hypotensive Resuscitation
Field trial of hypotensive resuscitation vs. Standard resuscitation in patients with hemorrhagic shock after trauma-a pilot
study
ROC Hypotensive Resuscitation Science
Traditional treatment of trauma patients> aggressive fluid resuscitation to restore circulating volume, SBP
Increasing animal and human studies showing detrimental effects of massive fluid resus prior to hemorrhage control
Associated with cardiac dysfunction, abdominal compartment syndrome, ARDS, hypothermia and coagulopathy
ROC Hypotensive Resuscitation Science
Three RCTS, two observational studies suggest harm of aggressive fluid resuscitation as opposed to no prehospital fluids until hospital arrival
No study shows clear superiority of aggressive fluid resus vs hypotensive resuscitation yet aggressive fluid resus cornerstone of ATLS and PTLS teaching
RCT required to better answer the question
ROC Hypotensive Resuscitation Methodology
Patient with shock after trauma randomized to either standard or hypotensive Resusc arm
Inclusion: blunt or penetrating trauma, age> 15 or 50 kg, SBP < 90, absence of severe head injury or GCS >8
Exclusions (many)> fluid started by non ROC agency, ongoing CPR
ROC Hypotensive Resuscitation Methodology
Complete randomization (as opposed to a priori) Participating agencies carry pre randomized,
sealed, numbered containers Patient randomized and entered once container
opened Containers with 1000 cc or 250 cc iv normal
saline bags EMS will not know randomization until container
opened
ROC Hypotensive Resuscitation Methodology
• Tote bag to hold two Hypotensive Resusc fluid boxes
• Two cardboard boxes per tote will disguise/blind different size of IV fluid bags
ROC Hypotensive Resuscitation Methodology
Once container opened if 1000 cc bag randomized to control arm:
IV fluid given as rapidly as possible until ER arrival
If prehospital volume of 2 liters reached fluid stopped if
SBP >110
ROC Hypotensive Resuscitation Methodology
If container opened and 250 cc bag randomized to experimental group:
IV hung and if radial pulse or SBP > 70 TKVO fluids
no radial pulse or SBP < 70 begin 250 cc infusion until radial pulse returns or SBP 70
EMS agencies given option of using radial pulse or SBP as means of BP monitoring
ROC Hypotensive Resuscitation Methodology
ALS trial Significant in-hospital component Bong Canister technique Hypotensive resuscitation in severe head
injury? Tracking of treatment canisters
Other Studies At Various Levels
ROC Hypothermia (PreHospital Hypothermia)
ROC RESUCE (Estrogen Use In Trauma)
EMS Challenges For All ROC Trials
Competing non ROC research Training and training cycles REB approvals Multiple studies…which one do we choose? SMC requirements for continued participation Paramedic research burnout Long down time between recent HS and PRIMED
Questions?