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Do the side effects of pre-hospital spinal immobilisation outweigh the potential benefits? A critical literature review.

Appendices.

Contents

Notes.............................................................................................................................................2

Appendix 1: Grey literature search results............................................................................................3

Appendix 2: Manual reference search results.......................................................................................5

Appendix 3: Primary database search results........................................................................................9

Ovid MedLine....................................................................................................................................9

Ovid EMBASE.....................................................................................................................................9

Cochrane Library..............................................................................................................................10

Pubmed...........................................................................................................................................10

Appendix 4: Sample completed questionnaire....................................................................................12

Part A: SIGN levels of evidence........................................................................................................12

Part B: CASP and Crombie checklists................................................................................................12

Total.................................................................................................................................................14

Appendix 5: Critical review results......................................................................................................15

Categories:.......................................................................................................................................15

Systematic reviews, critical analyses and meta-analyses.................................................................16

Systematic reviews, critical analyses and meta-analyses: Summary of results................................27

Effects of backboards......................................................................................................................29

Effects of backboards: Summary of results......................................................................................35

Effects of cervical collars..................................................................................................................36

Effects of cervical collars: Summary of results.................................................................................38

Selective Immobilisation..................................................................................................................39

Selective Immobilisation: Summary of results.................................................................................41

Extrication........................................................................................................................................43

Extrication: Summary of results.......................................................................................................46

Other aspects of immobilisation......................................................................................................47

Other aspects of immobilisation: Summary of results.....................................................................50

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Notes

It is acknowledged that “immobilisation” is the British spelling, and “immobilization” the American spelling. Both, however, are grouped under the Medical Subject Heading (MeSH) term “immobilization” and so articles with both British and American spelling were included in the search results.

Search terms were grouped under MeSH headings unless otherwise stated (e.g. “[keyword]”), to allow for a more comprehensive search.

Relevant titles were then saved and scanned by abstract. Those titles that were deemed relevant by abstract were saved onto reference managing software, where duplicates were removed.

Where available, the search function of journal websites were used to quickly find relevant articles.

After the first literature search was complete, the included journals were manually searched for relevant titles via the contents pages. This was completed on journals from the past 5 years i.e. back to January 2010.

If additional relevant records are found from the manual search of journals, these will be examined by abstract and full text to assess their eligibility for inclusion.

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Appendix 1: Grey literature search results

The following is a description of the steps taken to investigate potential sources of

unpublished literature in order to reduce the potential for selection bias in the

dissertation, as well as ensuring a comprehensive search is carried out. Any articles

found that were relevant by title and abstract were then examined by full text .

Potential source of

unpublished literature

No. of

relevant titles

Relevant articles to be examined

by full text

London Ambulance guidelines

clinical updates 2009 - present

1 None

Scottish ambulance service -

research papers

0 None

Northwest England ambulance

service – research papers

0 None

East of England ambulance –

research papers

0 None

South Central ambulance –

research papers

0 None

South East Coast Ambulance

Services – research papers

0 None

South western ambulance

services – research papers

0 None

West Midlands Ambulance

services – research papers

0 None

Yorkshire Ambulance services –

research papers

0 None

JRCALC website 1 None

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College of paramedics website 0 None

BASICS website UK 1 None

Fire service guidelines – firefit

steering group UK

1 None

SAMU France 1 None

Lojigma international, Mr Brian

Carlin and Dr John Ferris

1 A comparison of a new extrication device

(Belbin 2009)

U.S Military Medical research

articles

0 None

King’s College London Military

Medical research

1 None

Royal Air Force Centre for

Defense Medicine

0 None

Mountain rescue England and

Wales

1 None

Pre-hospital emergency care

council Ireland

2 None

AMBEX (conferences) 1 None

Review of spinal injuries unit in

Scotland (Conference)

1 None

American Spinal Injury

Association (ASIA) conferences

3 None

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Appendix 2: Manual reference search results

The Manual reference search was conducted as part of the secondary literature search.

The reference lists of articles were searched for relevant titles that were then followed

up. Reference lists examined included those from sources used in the introduction as

well as articles already deemed suitable for the critical review. The articles to be

examined by full text were then documented . The quality of the article was appraised to

determine whether it could be included in the critical review.

Sources where reference lists were examined.

Where source is used: intro/critical review/other*

Number of references

Number relevant by title

Number of relevant titles already examined

Articles relevant by abstract to be examined by full text

Connor et al, 2013

Introduction 22 15 13 Clearing the cervical spine in conscious trauma patients (Blackham, Benger 2009) Validity of a set of clinical criteria to rule out injury to the cervical spine in patients with blunt trauma. National Emergency X-Radiography Utilization Study Group. (Hoffman 2000)

Hauswald, 2013

Introduction 23 12 7 The cause of neurologic deterioration after acute cervical spinal cord injury. (Harrop 2001) Effect of cervical hard collar on intracranial pressure after

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head injury (Mobbs 2002)

Hauswald 2002

Introduction 44 21 17 Effect of spinal immobilization devices on pulmonary function in the healthy, nonsmoking man (Bauer 1988)

Oteir 2014 Critical review

45 16 10 Comparison of the Ferno Scoop Stretcher with the long backboard for spinal immobilization. (Krell) Prehospital stabilization of the cervical spine for penetrating injuries of the neck - is it necessary? (Barkana 2000)

Kwan et al 2007

Critical review

36 18 12 The efficacy and comfort of full body vacuum splints for cervical spine immobilisation (Hamilton 1996)

Ahn, Singh 2011

Critical review

58 30 25 Comparison of a long spinal board and vacuum mattress for spinal immobilisation. (Luscombe 2003) Spinal immobilization on a flat backboard: does it result in neutral position of the cervical spine? (Schriger 1991)

Fehlings Critical 15 5 5 None

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2011 review

Abram 2010 Critical review

32 19 13 None

Cordell 1995 Critical review

18 6 4 None

Chan 1994 Critical review

8 6 6 None

Oomens 2013

Critical review

36 6 5 None

Hemmes 2014

Critical review

32 11 10 None

Edlich 2011 Critical review

18 5 3 None

Johnson 1996

Critical review

14 7 7 None

Davies 1991 Critical review

18 14 13 None

Kolb 1999 Critical review

11 6 5 Cervical collars: a potential risk to the head-injured patient. (Ferguson 1993)

Dodd 1995 Critical review

10 3 2 None

Hunt 2001 Critical review

12 8 8 None

Vailaincourt 2009

Critical review

20 8 8 None

Hauswald 1998

Critical review

27 9 9 None

Kwan 2005 Critical review

45 33 29 Validity of a set of clinical criteria to rule out injury to the cervical spine in patients with blunt trauma. National Emergency X-Radiography Utilization Study Group.

Abram 2010 Critical review

32 19 13 Skin necrosis caused by a semi-rigid

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cervical collar in a ventilated patient with multiple injuries (Hewitt 1994)

Blackham 2009

Critical review

85 11 10 None


42 11 10 Prehospital spine immobilization for penetrating trauma--review and recommendations from the Prehospital Trauma Life Support Executive Committee. (Stuke 2011)

Ham 2014 Critical review

34 9 9 None

Stuke 2011 Critical review

36 11 10 None

Anderson Critical review

34 6 6 None

Berg 2010 Critical review

24 8 6 None

Mahshidfar 2013

Critical review

18 13 13 None

Del Rossi 2013

Critical review

13 7 5 None

Main 1996 Critical review

11 4 4 None

Domeier 2005

Critical review

30 11 10 None

Stroh 2001 Critical review

49 19 18 None

Hoffman 2000

Critical review

40 9 6 None

Belbin 2009 Critical review

9 1 1 None

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Ben Galim 2010

Critical review

45 4 3 None

Hauswald 1998

Critical review

27 9 9 None

Mazolewski 1994

Critical review

20 11 10 None

Ay 2011 Critical review

18 6 5 None

Bruijins 2013

Critical review

25 5 8 None

Del Rossi 2008

Critical review

40 10 9 None


26 5 5 None

Hood 2015 Critical review

45 11 10 None

Dixon 2014 Critical review

13 7 7 None

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Appendix 3: Primary database search results

Ovid MedLine

Search terms Results Filters Results after filters

Relevant by title

spinal immobilization [keyword]

129 English/Human 129 79

immobilization AND spinal cord injuries


Spinal cord injuries/therapy AND emergency medical services


Spinal injury/therapy AND emergency medical services


Immobilization/exp AND spinal cord injuries


Immobilization AND emergency medical services


Records identified via MedLine: 818 Records after filters: 761 Relevant by title (duplicates not yet removed) 489

Ovid EMBASE


Relevant by title

Spinal immobilization [keyword]


Spine/ AND immobilization/


Spine injury AND emergency health services


Spine injury AND treatment outcomes AND emergency health services


Spine AND immobilization AND

3 English/Human 3 1

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treatment outcomesSpinal cord injury AND emergency health services


Protective devices AND adverse effects AND spine

0 English/Human 0 0

Spinal cord injury AND emergency medical services AND treatment outcomes


Records identified via EMBASE: 1005 Records after filters: 1000 Relevant by title (duplicates not removed) 320

Cochrane Library


Relevant by title

Spinal immobilization [keyword]


Spinal injuries AND emergency medical services


Spinal cord injuries AND emergency medical cervices

4 English/Human 4 1

Immobilization AND spine 48 English/Human 44 14Immobilization AND emergency medical services


Records identified via Cochrane library: 153 Records after filters: 143 Relevant by title (duplicates not removed): 50

Pubmed


Relevant by title

[therapy/broad] spinal immobilization


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Systematic [st] AND spinal immobilization


Spinal injuries/therapy [majr] AND emergency medical services


Spinal cord injuries/therapy [majr] AND emergency medical services


(immobilization/adverse effects OR immobilization/therapy) AND spinal injuries


Spinal injuries/diagnosis/prevention and control AND protective devices


Immobilisation [majr] AND spine AND practise guidelines


Spinal cord injuries AND emergency treatment


Immobilization AND restraint, physical


Records identified via Pubmed: 1798 Records after filters: 1423 Relevant by title (duplicates not removed) 545

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Appendix 4: Sample completed questionnaire

Name of study Out of hospital spinal immobilisation: its effect on neurologic injury

Author Hauswald et al

Year of publication 1998

Part A: SIGN levels of evidence.[Directions] Determine the type of study design using the “SIGN study design classification flow chart”. Points are awarded according to the most suitable description available contained in the following table.

SIGN level of evidence Assigned score (points)

High quality meta analysis, systematic review of randomised control trials (RCT), or RCT with a low risk of bias.

(10)

Well conducted meta analysis, systematic review, or RCT with a low risk of bias.

(8)

Well conducted case control or cohort studies with a low risk of confounding bias and a moderate probability that the relationship is causal. (6)

Non analytic studies (4)

Expert opinion (2)

Part B: CASP and Crombie checklists.[Directions] Answer the ten questions appropriate to the study type of the article. Answers are scored according to the following table:

Answer Assigned score (points)

Yes (1)

No (0)

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Maybe/Don’t know (0.5)

Total for a maximum of 10.

Systematic review/Meta analysis

Randomised control trial

Case Control/Observational

Cohortstudies

Non Analytic/survey/expert opinion

Qualitative

study

Score(Points)

1) Did the review address a clearly defined question?

Did the trial address a clearly focused issue?

Did the study address a clearly focused issue?

Did the study address a clearly focused issue?

Did the study address a clearly focused question?

Was there a clear statement of aims of the research?

1

2) Did authors look for the right types of papers?

Was the assignment of patients to treatment randomised?

Did the authors use an appropriate method to answer the question?

Was the cohort recruited in an acceptable way?

Is the design appropriate to stated objectives?

Is a qualitative methodology appropriate?

1

3) Were all important relevant studies included?

Were all patients who entered the trial accounted for in the conclusion?

Were the cases recruited in an acceptable way?

Was exposure accurately measured to minimise bias?

Were samples obtained in an acceptable manner?

Was the research design appropriate to address aims of the research?

0.5

4) Did the review’s author do enough to assess study quality?

Were patients, health workers and study personnel blinded?

Were the controls collected in an acceptable way?

Was outcome accurately measured to minimise bias?

Was bias sought out and accounted for?

Was recruitment strategy appropriate to aims of the research?

0.5

5) If the results of the review were combined, was it reasonable

Were the groups similar at the start of the trial?

Was exposure accurately measured to minimise bias?

Have authors taken confounding factors into

Is there a suggestion of haste?

Was data collected in a way that addressed the research

1

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to do so? account? issue?

6) Are the overall results of the review clear?

Aside from experimental intervention were the groups treated equally?

Have authors taken confounding factors into account?

Was the follow up of subjects complete and after long enough?

Have authors taken confounding factors into account?

Has the relationship between researcher and participant been adequately considered?

1

7) Are the results precise?

Was the estimate of treatment effect precise?

Is there a strong association between exposure and outcome? (Odds ratio)

Is there a strong association between exposure and outcome?

Is there evidence to suggest that the results were not serendipitous?

Have ethical issues been taken into consideration?

1

8) Can results be applied to the local population?

Can results be applied to the local population?

Are the results precise?

Are the results precise?

Is there evidence to suggest results were not generalised?

Was data analysis sufficiently rigorous?

0.5

9) Were all important outcomes considered?

Were all clinically important outcomes considered?




Is there a clear statement of findings?

1

10)

Are benefits worth the harms and costs?

Are benefits worth harms and costs?

Do results fit with other available evidence?



Is the research valuable?

0.5

Total (points /10) 8

Total

[Directions] COMBINE SCORES FROM PARTS A and B

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APPRAISAL TOTAL (POINTS /20) 14

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Appendix 5: Critical review results

The following table illustrates the results of the critical review:

Results; Experiment results of the study and conclusions of the article. Rating/20; Result of critical appraisal via customised checklist (see Appendix 1 and

Methodology) Comments; any additional concerns or noteworthy remarks about the article. Agreement with Consensus Statement: determines the degree of correlation between the

results of the study being appraised to the Consensus Statement released in 2013

Categories:

1. Systematic reviews, critical analyses and meta analyses: Oteir 2015 to Kwan 20052. Effects of back-boards: Hemmes 2014 to Cordell 19933. Effects of cervical collars: Mobbs 2002 to Davies 19934. Selective Immobilisation: Vallaincourt 2009 to Hoffman 20005. Extrication: Dixon 2014 to Belbin 20096. Other aspects of immobilisation: Bruijns, Gully 2013 to Mazolewski 1994

Systematic reviews, critical analyses and meta-analyses.

REFERENCE

JOURNAL

TITLE

DESIGN

NO. OF

ARTICLES

PURPOSE RESULTS COMMENTS AGREEMEN

T WITH CONSENSU

S STATEMEN

T

RATING/20

OTEIR ET AL 2015

INJURY

Systematic

review

8 1. To answer the question: “In adult patients attended by EMS following suspected cervical spinal cord injury, does

1. Cervical spinal immobilization is harmful when used with penetrating neck trauma.

2. Cervical spinal

Did not investigate the efficacy of cervical immobilization technique by personnel, or

Agrees with consensus statement with

17.5

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SHOULD SUSPECTED CERVICAL SPINAL CORD INJURY BE IMMOBILISED?: A SYSTEMATIC REVIEW

the application of a cervical collar improve patient outcome versus no collar at all?”

2. To identify mechanisms of injury that do not require cervical spinal immobilization.

3. To identify patient subgroups who may benefit from the practice.

immobilization remains controversial with blunt trauma.

3. Recommends further trials to help identify mechanisms of injury and to identify benefitting patient subgroups.

consequences of ill-fitting collars. Did not investigate the efficacy of Manual In-Line Stabilisation as an alternative to the collar. Excluded studies based on healthy volunteers. Though these are not as strong sources of evidence than trials carried out on real patients, they may still have held valuable information. Newcastle-Ottawa Scale used to score papers in the study, a 9 star system with limited options leading to higher scores than other methods of appraisal would suggest. Heterogeneity in study outcomes leading to an inability to combine some results.

regards to avoiding cervical spinal immobilization in penetrating trauma patients, and encouraging further research into the efficacy of cervical spine immobilization. Also agrees that there are patient groups that receive immobilization that do not require it, and encourage a more selective practice by identifying these patient groups.

HOOD, CONSIDINE 2015

AUSTRALASIAN EMERGENCY NURSING JOURNAL

SPINAL IMMOBILISATION IN PRE-HOSPITAL AND

Systematic

review

47

To examine the available evidence in order to answer the question, “In victims with suspected spinal injury, does the use spinal immobilisation during pre-hospital or emergency care (in-line-manual-stabilisation, head blocks, spinal boards and cervical collars), compared with no immobilisation, affect neurological outcome or other outcomes (prevention of movement, spinal positioning/alignment, comfort or pain, and complications)?”

15 studies were supportive of phSI, 13 studies were neutral and 19 were against the practice. No published high level studies assessing the efficacy of phSI, or showed improved neurological outcomes with its use. Most of the available data is extrapolated from, for example, healthy volunteers. phSI may lower spinal movement, but the clinical significance of this remains uncertain. phSI is associated with harmful

Does not hand search selected journals. The search for unpublished is mentioned but not documented in detail. Extent of grey literature search is thus unknown. Backwards and forwards searching strategies mentioned but not explained. Quality scoring system used differentiates studies into “Good/fair/poor”. Only three available categories of quality available to describe the article. Used numerous high quality databases, varied search terms and used detailed

Agreement that the efficacy of phSI is undetermined and there is a requirement for further research on determining its efficacy using a prospective trial.

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EMERGENCY CARE: A SYSTEMATIC REVIEW OF THE LITERATURE

complications, and may mask pathology. phSI may delay definitive diagnosis and subsequent care. Prospective studies are required using real patients in a real clinical setting.

inclusion and exclusion criteria. Data presented in a readily comprehensible table format.

OTEIR ET AL 2014

PRE-HOSPITAL AND DISASTER MEDICINE

THE PREHOSPITAL MANAGEMENT OF SUSPECTED SPINAL CORD INJURY: AN UPDATE.

Systematic

review

37

Review the current literature on the epidemiology of traumatic spinal cord injury and the practice of pre-hospital spinal immobilisation

1) Pre-hospital spinal immobilization is not based on scientific evidence and may be overly conservative.

2) Little evidence supporting link between the practice and better patient neurological outcomes.

3) Calls for randomized control trials and large prospective studies to analyse benefits, harms and use of pre-hospital SI.

Overall results of the review not clear. Focused only on English studies between 2000 and 2012. Did not mention search for unpublished literature. Did not mention journal searches. Claimed that there was a “paucity” of evidence on benefits of phSI, however the sources of this paucity were not identified. Manually searched reference lists

Much agreement with consensus guidelines regarding the lack of evidence for spinal immobilization and the requirement for further research.

17

HAM ET AL 2014

JOURNAL OF TRAUMA AND ACUTE CARE SURGERY

PRESSURE ULCERS FROM SPINAL IMMOBILIZATION IN

Systematic

review

13

Gain insight into the incidence and severity of pressure ulcers in relevance to spinal immobilization in adult trauma patients, including risk factors and possible treatments.

Incidence of pressure ulcers related to spinal immobilization ranges between 6.8% and 38%, and occurs mainly on the occiput, chin, shoulders and clavicles. Possible interventions include collar refit, position change and skin assessment, however this would be difficult to achieve, given the care with which patients with suspected spinal cord injury are handled.

Broad aims that didn’t answer a specific question. Broad search that included all forms of evidence from all years. Only looked at quantitative studies. Used the Research Appraisal Checklist for nursing to assess the quality of all of their articles, but had to significantly adjust the checklist to suit the study. This lead to different papers being appraised in less objective ways, potentially leading to appraisal bias. Included healthy volunteers and were able to include studies of multiple languages. Used the Preferred

Agrees with consensus statement in defining the harms of full spinal immobilization.

16

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TRAUMA PATIENTS: A SYSTEMATIC REVIEW

Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. A seemingly evidence based protocol to carry out the review reliably. Evidence of minimizing bias in appraisal of articles by performing the review independently by two reviewers and dealing with disagreements by consensus.

SUNDSTROM ET AL 2014

JOURNAL OF NEUROTRAUMA

PREHOSPITAL USE OF CERVICAL COLLARS IN TRAUMA PATIENTS: A CRITICAL REVIEW

Critical Review

50

To discuss the pros and cons of collar use in trauma patients

The existing evidence for collar use is weak. There are many documented adverse effects of cervical collars. The routine use of cervical collars should be phased out. The use of pre-hospital spinal immobilization should not delay transport to definitive care.

Only used one database for the critical review. Therefore important articles may have been missed. Search was limited to English and Human studies. This may have led to relevant data being omitted from the study. Received a grant from the Western Norway Regional Health Authority, which may have influenced the results of the study. Did not cite some authors because of space limitations. The method of critical appraisal of the articles was not documented. Appraisal may have been subjective, introducing potential bias Numerous authors were used in the search and critical review of the articles, limiting bias. Borderline articles were included, helping to minimize missing data. Experts in the field were contacted, incorporating their knowledge and expertise. Reference lists were searched, making the literature search more comprehensive.

Agrees with consensus statement against the use of cervical collars.

17.5

AHN, SINGH 2011

Systematic

review

44

To answer the following questions:

1) What is the optimal type and duration of pre-hospital spinal

1) Immobilisation for patients with SCI should include head immobilization, backboard and

Authors did not demonstrate the methodology behind appraising the quality of articles included in the systematic

The consensus agreement would

17.

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JOURNAL OF NEUROTRAUMA

PRE-HOSPITAL CARE MANAGEMENT OF A POTENTIAL SPINAL CORD INJURED PATIENT: A SYSTEMATIC REVIEW OF THE LITERATURE AND EVIDENCE-BASED GUIDELINES.

immobilization for SCI victims?

2) During airway manipulation pre-hospital, what is the best form of immobilization?

3) What are effects of transport time on outcomes of acute SCI patients?

4) What is the role of pre-hospital care providers in cervical spine clearance?

cervical collar. Get the patient off the hardboard as soon as possible. Use of soft boards recommended to lessen incidence of pain and pressure ulcers.

2) Use of MILS recommended for pre-hospital immobilization during airway manipulation. Cervical collar should not be relied on. Indirect methods of intubation cause less movement of the cervical spine than Miller Blade laryngoscopy.

3) Transport to the definitive centre of care should occur within 24 hours of injury.

4) EMS personnel can be trained to use selective immobilization criteria to safely clear spines and immobilize patients at risk. Implementation of this would depend on the area’s legal and health policy factors.

review. No journal search carried out. Authors decided that 80% consensus was significant. It wasn’t clear how significance was determined or the significance of 80% as a cut off value. Used four distinct questions to lower ambiguity. Bibliographies of selected articles were searched for further titles. The study was carried out by nine specialists in the field. Two reviewers independently selected articles, and a third reviewer reconciled disagreements, minimizing selection bias. The Delphi method was used between panels of experts to come to conclusions based on the evidence. (Delphi method involves rounds of anonymized written suggestions from the panel members which are then discussed)

advocate the use of a vacuum board rather than a spinal board. Both sources advocate the use of MILS and dissemination of selective spinal immobilization protocol. Both sources argue against the use of cervical collars.

5

STUKE ET AL 2011

JOURNAL OF TRAUMA

PREHOSPITAL SPINE IMMOBILIZATION FOR PENETRATING TRAUMA--REVIEW AND RECOMMENDATIONS FROM THE

Systematic

review

20

1. To determine the incidence of unstable fracture and spinal cord injury in the penetrating trauma victim.

2. To determine the natural history of spinal cord injury in penetrating trauma victims

3. To determine if spinal immobilization is necessary for patients with penetrating trauma.

There is no evidence to support the use of spinal immobilization for patients with isolated penetrating trauma to the head, neck or torso. Clear evaluation of the neck takes priority at all times over immobilization in these patients. It may be acceptable to use spinal immobilization in these patients if a focal neurological deficit is witnessed, but there is still little evidence to support the efficacy of this practice.

Did not list inclusion or exclusion criteria, or restrictions to types of study being examined. Only English language studies were used . Search only mentioned use of PubMed, Medline and Cochrane, when the search could have been spread to other sources, and secondary searches and journal searches carried out. Articles selected by one author, confirmed by another and the final review by a third author. Bibliographies were cross referenced, the review had members working on it, and disputes were resolved by a third author. Published on behalf of the pre-hospital trauma life support

Supports consensus statement stance against the use of conservative spinal immobilization for patients with isolated penetrating trauma.

16.5

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PREHOSPITAL TRAUMA LIFE SUPPORT EXECUTIVE COMMITTEE.

committee.

ANDERSON 2010

JOURNAL OF ORTHOPEDIC TRAUMA

CLEARANCE OF THE ASYMPTOMATIC CERVICAL SPINE: A META-ANALYSIS

Meta-analysi

s

14

To determine the most effective means to clear the cervical spine in alert asymptomatic trauma patients.

These showed that selective protocols had a negative predictive value of 99.8% and a sensitivity of 98.1%. The study favours the NEXUS and CSSR which made up a significant statistical weight in the study. CSSR was found to have a slightly higher sensitivity and a higher specificity than NEXUS

Did not precisely indicate the purpose of the study. In the literature search, did not undertake manual journal searches or mentioned a secondary search of the literature. Undertook statistical analysis of all of the protocols together to come up with an overall statistic, however it would have been better to definitively determine which protocol worked best. Did not explain a protocol determining the quality of the articles being used in the study, may have introduced bias as a result. Bibliographies of selected articles were searched for further titles as well as other sources such as NEXUS. Each study was judged by three independent authors.

Agree with consensus guidelines in supporting the investigation and need for dissemination of a selective immobilization protocol.

15.5

ABRAM ET AL 2010

THE SURGEON; JOURNAL OF ROYAL COLLEGE OF SURGEONS IN EDINBURGH AND

Critical Review

32

Critically review on the outcomes of management by routine spinal immobilization on trauma victims.

Immobilisation could be contributing to mortality and morbidity in some patients and this warrants further investigation.

Lack of information in methodology section (only one paragraph long) Did not document details in methodology to find unpublished literatures. Did not mention journal searching. Only used one database (Medline) Authors did not objectively assess quality of papers included in study. Did not go into the topic of selective immobilization.

Agreement with consensus study regarding the lack of evidence for immobilization but the large body of evidence documenting harms.

17

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IRELAND.

ROUTINE SPINAL IMMOBILIZATION IN TRAUMA PATIENTS: WHAT ARE THE ADVANTAGES AND DISADVANTAGES?

BLACKHAM, BENGER 2009

TRAUMA

“CLEARING” THE CERVICAL SPINE IN CONSCIOUS TRAUMA PATIENTS.

Systematic revie

w

75

Examine the advantages and disadvantages of different methods of examining the conscious co-operative patients with suspected cervical spine injury.

For detecting cervical spine fracture, examination was 89% sensitive compared to lateral cervical spine radiography which was 67% sensitive NEXUS and CCSR both approach 100% sensitivity, with CCSR being slightly more sensitive and specific. Combining NEXUS and CCSR has no substantial evidence to suggest it is more effective than NEXUS or CCSR alone. Doctors and non-medical professionals have a high level of agreement when using the CCSR or NEXUS. CCSR can be used by paramedics with a sensitivity approaching 100% and with good agreement with physicians. The mechanism of injury highly correlates with the incidence of spinal cord injury however the CCSR and NEXUS criteria were as capable of detecting these injuries.

Lack of explanation for inclusion/exclusion criteria. No search for unpublished literature – publication bias. Search strategies were not explained, and filters neither specified nor explained.

Much agreement with consensus guidelines with regards to efficacy of selective spinal immobilization protocol.

16

KWAN, BUNN, ROBERTS 2007

EMERGENCY

Systematic revie

w

0 To quantify the effects of different immobilization techniques on trauma patients, including no immobilisation

No randomized control trials. These are needed to reliably quantify the effects of different immobilization techniques. As immobilization may affect the airway the link of phSI to increased

There was no conclusion to the article other than the fact that there are no randomized control trials on this topic. As authors were extracting data on e.g. method of allocation concealment, they

Agrees with consensus statement in that phSI could be having significan

18

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MEDICINE JOURNAL

SPINAL IMMOBILISATION FOR TRAUMA PATIENTS

mortality and morbidity cannot be excluded. Large prospective studies are required to validate the decision criteria for selective immobilization.

were not blind to author or journal, which may have introduced publication bias. Method for sensitivity analysis was not described. Did not mention unpublished data. Literature search covered a wide variety of sources. Articles were assessed by two different authors with a third author to resolve disputes. Articles were assessed separately on their degree of allocation concealment, making outcomes more reliable.

t negative effects on patients, and that further study is required.

KWANN ET AL 2005


EFFECTS OF PREHOSPITAL SPINAL IMMOBILIZATION: A SYSTEMATIC REVIEW

Systematic revie

w

17

To evaluate the effects of spinal immobilization on healthy participants

Collars, spine boards, vacuum splints and abdominal/torso strapping led to a significant decrease in spinal movement. Significant adverse effects include increased respiratory effort, skin ischemia, pain and discomfort. Longer hospital stays and increased costs. Efforts to establish a selective approach are welcome. Need randomized control trials on trauma victims.

Systematic review did not cover trials completed on trauma victims. Heterogeneity of results. No manual journal search. Authors and manufacturers were contacted directly. 10% of articles were appraised again (however, the selection of this 10% was not specified). Quality of allocation concealment was assessed in the studies.

Agreement on the potential adverse effects of immobilization, alluded to the debate on the efficacy of immobilization and encouraged selective immobilisation

18.5

Systematic reviews, critical analyses and meta-analyses: Summary of results

A systematic review carried out in 2011 came to a number of conclusions (Ahn et al. 2011).

These included:

o Removing the patient from the hard board as soon as possible, and finding softer

alternatives to the hard board.

o MILS is a suitable alternative to the cervical collar.

25 | P a g e

o Transport to a definitive centre of care should occur within 24 hours of injury.

o EMS personnel can be trained to clear the spine in a pre-hospital setting.

A meta-analysis of the literature regarding selective immobilisation was carried out to

determine the best protocol (Anderson et al. 2010). The study favoured NEXUS and CCSR,

finding their sensitivities to be approaching 100% (99.8%), with the CCSR having a high

specificity (42.5%).

The findings of the meta analysis are reinforced by a systematic review in 2009 (Blackham &

Benger 2009), which examined the advantages and disadvantages of using a clinical

clearance protocol on alert co-operative trauma patients. This systematic review found that

clinical examination was more sensitive than lateral c-spine radiography in detecting cervical

spine fracture (89% vs 67%). It also reported that the CCSR was slightly more specific than

NEXUS, as well as being slightly more sensitive.

In 2014, Oteir et al carried out a systematic review on the epidemiology of traumatic spinal

cord injury and came to the conclusion that phSI is not based on scientific evidence and there

is little link between the practise and improved neurological outcomes. Further research into

the practice is required.

Oteir carried out a second systematic review in 2015, focusing on the efficacy of cervical

spinal injury, and concluded that cervical spine immobilisation is unnecessary in penetrating

trauma, and the practice remains controversial in blunt trauma.

Hood et al released a study in 2015 which commented on the lack of high level evidence

available to validate to use of phSI, and found that most of the data available concerning phSI

was extrapolated from, for example, healthy volunteers.

A Cochrane Review updated in 2007 (Kwan et al. 2001) found no randomised control trials

that could be used to quantify the effects of spinal immobilisation on patient outcomes,

highlighting the need for these to be carried out. This study was restricted to patients.

Another Cochrane review by the same authors sought to answer the same questions, but

allowing healthy subject data (Kwan I. Bunn F. 2005). This found that current methods of

spinal immobilisation succeed in reducing gross movement of the spine, however the

relationship between this effect and neurological outcomes was not confirmed, and that the

26 | P a g e

practice could harm the patient. The review called for randomised control trials on patients, as

were searched for in the 2001 Cochrane review.

A critical review was released in 2010 in relation to the outcomes of routine phSI on trauma

patients, (Abram & Bulstrode 2010), and found that phSI could be contributing to patient

morbidity and mortality.

A systematic review concerning the relationship between phSI and pressure ulcers

established a significant correlation (6.8% to 38% incidence) (Ham et al. 2014).

Stuke et al published a systematic review in 2011 concerning penetrating trauma and phSI

and found no evidence supporting the use of phSI in these patients, unless perhaps a focal

neurological deficit is witnessed. It was determined in the review that clinical evaluation of the

neck of the penetrating trauma casualty takes precedence over any immobilisation efforts.

Sundstrøm carried out a critical review in 2014 which found insufficient evidence to endorse

the routine use of cervical collars and recommended against its use (Sundstrøm et al. 2014)

Effects of backboards

REFERENCE

JOURNAL

TITLE

DESIGN

PURPOSE

RESULTS

COMMENTS AGREEMENT WITH

CONSENSUS

STATEMENT

RATING/20

HEMMES, BRINK, 2014

INJURY

EFFECTS OF UNCONSCIOUSNESS DURING SPINAL

Comparative, Randomised observation

Use of pressure monitors and examination to compare the tissue-interface pressures between a rigid spinal

Pressures were much lower for the soft board than the rigid board. Furthermore, pressures were lower in anaesthetized patients overall. Shows need for softer

Patients spending 2 hours on the board, when it was previously mentioned that the period of time that patients usually remain on the board in reality is approx. 1 hour. The subjects were undergoing abdominal hernia repair during the experiment. May effect ability to extrapolate results to general population. The control, healthy subjects were only on the spinal board for 15 minutes, as opposed to the anesthetized patients of 2 hours. Redness of the sacrum was assessed according to “diffuse,

Agreement that softer alternatives to the rigid backboard should be used for anything other than extricati

16

27 | P a g e

IMMOBILIZATION ON TISSUE-INTERFACE PRESSURES: A RANDOMIZED CONTROLLED TRIAL COMPARING A STANDARD RIGID SPINE BOARD WITH A NEWLY DEVELOPED SOFT-LAYERED LONG BOARD

board and a softer board on both conscious volunteers and anesthetized patients undergoing surgery.

alternatives, especially for unconscious patients who cannot readjust themselves to relieve pressure, and may also be deduced that conscious patients under higher tissue-interface pressure may readjust themselves more on the rigid board, compromising the stabilization the rigid board was designed to provide.

localized or absent”. This could have been more objective. Healthy volunteers may have been treated differently than surgery patients. Patients may anatomically distribute their weight to different parts of the bed, but there is no evidence in the text to suggest that this was accounted for. Patients with pressure ulceration or previous back pain were excluded, minimizing confounding factors. A power analysis was performed, confirming the validity of the study.

on.

MAHSHIDFAR 2013


LONG BACKBOARD VERSUS VACUUM MATTRESS SPLINT TO IMMOBILIZE WHOLE SPINE IN TRAUMA VICTIMS IN THE FIELD: A RANDOMIZED CLINICAL TRIAL.

Randomised clinical

trial

To compare the efficacy, comfort, ease of application and time of application of a long spinal board to a vacuum mattress on trauma patients.

Long spinal board was easier to apply, faster to apply and more comfortable for the patient than the vacuum mattress. It also restricted movement more effectively.

Different outcome than previous studies. Authors attribute this to the fact that there is the first study conducted on trauma victims rather than healthy volunteers. The analysis of movement was by observation alone. Paramedics were accustomed to the use of the long back board as it is what they commonly use, which could explain the difference in speed and ease of application. No mention of standardization of measurement. E.g. when was timing stopped and started? How were patients instructed to use the visual analogue scale? Does not describe extent of training that physicians used for vacuum mattress. Sample size of 60. Low. Only one brand of long spinal board and one brand of vacuum mattress were used in the study. Study was carried out in Tehran, Iran. Results may not apply to the same extent to the U.K. due to different protocols, training and patient demographics. 60 patients were mentioned in the study, however there is no explanation as to whether these were all of the patients who met the inclusion criteria or if any patients were excluded for any reason. May be missing data.

Does not agree with consensus statement to use vacuum mattress

13

EDLICH, MASON ET AL 2011

Observational study

Study the Back Raft immobilization device

Back raft usage resulted in lowered interface pressures

Small sample size (10 patients) Subjects were all healthy, may not reflect on trauma patients. Patients only immobilized for 30 minutes, may not reflect average time on the board for trauma patients

Agrees with consensus statement that

13.5

28 | P a g e

AMERICAN JOURNAL OF EMERGENCY MEDICINE

REVOLUTIONARY ADVANCES ON ENHANCING PATIENT COMFORT ON PATIENTS TRANSPORTED ON A BACKBOARD

as a method to lower pain and incidence of pressure ulcers.

and pain reports in the healthy volunteers. Back raft or other mattress system recommended.

(which this study claimed was approx. 77 minutes) Two specific brands of device were compared (Back Raft versus XTRA). May limit ability to extrapolate results to wider population. “Back Raft is 100% latex free and 100% x-ray translucent”. Language may indicate an author bias towards the backraft. Narrow range of age for test subjects (33-59yrs)

softer alternatives to the backboard are required for anything other than extrication.

BERG, NYBERG ET AL, 2010

PRE-HOSPITAL EMERGENCY CARE

NEAR-INFRARED SPECTROSCOPY MEASUREMENT OF SACRAL TISSUE OXYGEN SATURATION IN HEALTHY VOLUNTEERS IMMOBILIZED ON RIGID SPINE BOARDS

Experiment

Determine the effects of prolonged immobilization of healthy volunteers on a rigid spinal board on sacral tissue oxygen saturation.

Sacral tissue oxygenation was at low levels, indicating high risk of patients developing pressure ulcers before admission to hospital if transported on a spinal board. This risk could theoretically increase if the patient has hypotension.

Tissue oxygen saturation may vary between individuals, so may not be an objective indicator. Posters around a university campus were used to recruit volunteers, introducing selection bias to the study. Excluded underweight patients without explanation (BMI ,18) Only studied healthy volunteers over 18 years old. Excluded an anomalous result without trying to explain the cause of the anomaly.

Agrees with consensus guideline against use of backboards for prolonged immobilisation.

14

DEL ROSSI 2010


Observational study

To compare the log roll technique, the 6-person lift technique and the scoop

The scoop stretcher’s abilities to limit movement are comparable if not superior to those of the two

Use of lightly embalmed cadavers. May not be comparable to live subjects. Cadavers used are aged around 80 years old. May not accurately reflect outcome for younger victims. The artificial lesion may not produce the same pathophysiology that different lesions experienced in trauma could produce. Only one type of scoop stretcher was used. Scoop stretcher design varies and a different model may

Agrees with consensus statement encouraging use of scoop stretche

14

29 | P a g e

ARE SCOOP STRETCHERS SUITABLE FOR USE ON SPINE-INJURED PATIENTS?

stretcher in terms of motion generated in multiple planes on lightly embalmed cadavers with an artificially placed lesion in the cervical spine.

manual techniques in this study.

have produced different results. Differing experiences and abilities with each technique may have influenced results.

r.

KRELL 2006

PRE-HOSPITAL EMERGENCY CARE

COMPARISON OF THE FERNO SCOOP STRETCHER WITH THE LONG BACKBOARD FOR SPINAL IMMOBILIZATION.

Prospective

observational

To compare a Ferno scoop stretcher to a long spinal board in terms of comfort, security and spinal movement.

There was statistically less movement in the Ferno Scoop stretcher than the long spinal board. There were also increased comfort levels reported for the Ferno scoop stretcher. This is mainly due to the lack of log rolling required.

Study only examined healthy, young, sober volunteers. Uncooperative patients may lead to a different picture of results. Of 31 subjects, only 7 were female. The sensors placed to record movement may have moved slightly. The stationary phase, designed to simulate an ambulance journey, was done on a carpet floor, which wasn’t an accurate representation, not taking into account movement of the ambulance or being on a gurney. Ferno funded the project, however results would be published whether positive or negative. The Z movement used to centralize patients will vary in movement depending on how much patients need moved to be centered on the board. Visual analogue scale was used, which is a more objective method of quantifying patient feedback than other methods. Patients were not informed of the hypothesis before the experiment.

Agrees with consensus statement recommending increased use of scoop stretcher for the movement of patients, as opposed to a rigid backboard.

14.5

JOHNSON, HAUSWALD, STOCKOFF 1996


COMPARISON OF A VACUUM SPLINT

Prospective non randomi

zed

Compare vacuum splint to a rigid backboard in terms of speed pf application, comfort and degree of immobilization.

Vacuum splint was more comfortable and better at immobilizing overall, however rigid backboard was slightly better at immobilizing the head. Both can be applied in reasonable

A convenience sample of 30 students was used for the first phase. This sample may not represent the population. Students in groups of 4 may or may not have elected the more capable students to lead in their individual cases, lowering consistency. The transition to phase 2 adds new students to the group that has experience with phase 1, potentially confounding results. Phase 2, when student is supposed to verbally announce when during the tilt that they start to slip. This may be a subjective and inconsistent measurement. Did not take into consideration movement of the torso, which also contributes to spinal movement.

Agrees with consensus recommendation to use a vacuum splint rather than a rigid backboard for spinal immobilization.

13.5

30 | P a g e

DEVICE TO A RIGID BACKBOARD FOR SPINAL IMMOBILIZATION.

time frame.

HAMILTON, PONS 1996

JOURNAL OF EMERGENCY MEDICINE

THE EFFICACY AND COMFORT OF FULL-BODY VACUUM SPLINTS FOR CERVICAL-SPINE IMMOBILIZATION

Prospective

crossover study

Compare vacuum mattress to long spinal board in terms of degree of immobilization and comfort

Vacuum splint was better at limiting range of motion than long spinal board and was also more comfortable.

Sample has a narrow age range (20 to 57 years old) Use of only one type of vacuum mattress, which may not reflect results for all types. Small sample size of healthy volunteers, may not simulate trauma. Lack of time for patients to recover before being mobilized a number of times, possibly carrying pain over from previous immobilisations. Only 10 minutes in respective devices, does not simulate majority of transfer times to ED. A power value was given, clarifying validity of findings. A small pilot study was carried out to validate methods of measurement. Measurements were repeated to increase reliability of results. Patients were assigned to the two boards randomly, and then crossed over, minimizing procedure bias.

Agrees with consensus guideline on use of vacuum mattress.

13.5

MAIN, LOVELL 1996

JOURNAL OF ACCIDENT AND EMERGENCY MEDICINE

A REVIEW OF SEVEN SUPPORT SURFACES WITH EMPHASIS ON THEIR PROTECTION OF THE SPINALLY INJURED.

Prospective observational study

Compare the rigid spine board to a vacuum mattress in terms of tissue interface pressures and comfort.

Vacuum splint had lower tissue interface pressures than the rigid spinal board (233.5mmHg vs 94.8mmHg). Higher reported levels of comfort for the vacuum mattress. The spinal board did not support the lumbar lordosis.

Level of familiarity of army medics with e.g. the vacuum mattress unspecified. Each surface may distribute pressure from the body differently, but the sensors were placed on the same point of the patient’s body. This could lead to discrepancies in measurement. Measurements only taken once, no repetition to increase reliability of results. No specified time allowed for subjects to recover before being subjected to the next surface. Comfort levels were not objectively measured e.g. with a visual analogue scale.

Agrees with consensus guideline on use of vacuum mattress.

14

CHAN, GOLDBERG, 1993

Prospective

observational

Determine the effects of 30 minutes of

100% reported pain 55% “moderate to severe”

Recruitment of a small sample, many of which were related. Only one type of collar was used (Stifneck). No elderly patients in sample (ranged 10 to 43yrs)

Supports consensus guideline

13

31 | P a g e

ANNALS OF EMERGENCY MEDICINE

THE EFFECTS OF SPINE IMMOBILIZATION ON HEALTHY VOLUNTEERS

standard immobilization on healthy volunteers with respect to pain and discomfort.

29% reported additional symptoms over the next 48 hours

Confounding events may have occurred during 48hr follow up to explain delayed symptoms as subjects were not monitored at this time. Patients may have discussed the experiment amongst themselves, contaminating subjective data. “How do you feel?” open question used to determine patient feedback. Response to this open question is subjective and could lead to missing or inaccurate feedback of devices. The use of “mild, moderate, severe” instead of a visual analogue scale, made the data less objective. No suggestion was made that patients would be in discomfort before the experiment, minimizing procedure bias.

recommendation to limit time on a rigid backboard as much as possible.

CORDELL, HOLLINGSWORTH ET AL 1993


PAIN AND TISSUE INTERFACE PRESSURES DURING SPINAL BOARD IMMOBILISATION

Prospective

crossover study

Pain reports and interface pressures for healthy volunteers used to compare mattress with no mattress immobilisation on spinal board

Immobilization on rigid spine board causes pain and may also cause pressure ulcers. Mattresses between board and patients should be considered as standard practice.

Only one type of air mattress used in the study. May not be representative of every mattress available. No mention of outside funding or conflicting interests, but only one type of measuring device used, supplied by EHOB industries. Study only used healthy volunteers. May not represent efficacy of treatment in trauma patients. Only patients without previous back pain and patients not taking pain medication were allowed to take part in the study. A 100mm visual analogue scale was used to assess pain which minimizes ambiguity in taking this measurement.

Agreement that softer alternatives to the rigid backboard should be used for anything other than extrication

13.5

Effects of backboards: Summary of results

11 studies were investigated in relation to the effects of the long spinal board on the spinal

immobilised patient. These included studies on healthy volunteers and real patients.

It was found that subjects report significant amounts of discomfort and pain when secured to

the board, without providing support for the lumbar lordosis. (Cordell et al. 1995), (Chan et al.

1994), (Main & Lovell 1996).

32 | P a g e

Techniques such as near infra-red spectroscopy, pressure monitoring and physical

examination found that there were high tissue-interface pressures between subjects and the

spinal board. This lead to lower perfusion of certain points on the patient (sacral region,

thoracic kyphosis and the occiput) which vastly increases the possibility of tissue damage and

subsequent pressure ulcers. The process of developing a pressure ulcer could begin during

the journey to hospital. An effect which could possibly be exasperated in unconscious or

hypotensive patients. (Berg et al. 2010), (Hemmes et al 2014).

Softer alternatives such as an interposed mattress or Back Raft system has been shown to

decrease levels of pain, discomfort and tissue-interface pressures. (Edlich et al. 2011),

(Cordell et al. 1995)

Another alternative to the rigid spinal board is the Scoop stretcher. Due to its mechanism of

application (two halves which connect underneath the supine patient) it has the potential to

minimise the amount of handling of the patient required, and thus lower the potential for

movement. It has also been found to be more comfortable than the long spinal board. (Del

Rossi et al. 2010), (Krell et al 2006).

The Vacuum mattress was found in two studies to limit overall motion of the patient to a

greater extent than that of the long spinal board (Johnson et al. 1996), (Hamilton & Pow

1996). The device was also reported to be more comfortable and was found to have lower

interface tissue pressures (Hamilton & Pow 1996), (Main & Lovell 1996).

One study, (Mahshidfar et al. 2013), differs from the other articles having found that the long

spinal board was faster and more convenient to paramedics as well as more comfortable for

the patient than the vacuum mattress. The authors also concluded that the spinal board

limited movement more than the vacuum mattress. This paper represents an anomaly,

however it has a low appraisal score (13).

Effects of cervical collars

REFERENCE

JOURNAL

TITLE

DESIGN

PURPOSE

RESULTS


CONSENSUS

RATING/20

33 | P a g e

STATEMENT

MOBBS 2002

ANZ JOURNAL OF SURGERY

EFFECT OF CERVICAL HARD COLLAR ON INTRACRANIAL PRESSURE AFTER HEAD INJURY

Prospective

observational

Determine the effect of a Laerdal hard collar application

on ten trauma

patients with a GCS 9 or

below.

Laerdal collar

caused a mean

increase of 4.4mmHg ICP. There

was a larger increase in

patients that went on to

have favorable outcomes.

Claims that the cervical collar should be removed as soon as possible to avoid rises

in ICP.

Differing devices used to measure ICP in different patients. The author was in charge of

handling the patients alone. There were only 10 patients in the sample, only 2 of which were

female. May limit ability to generalize results.

The age range of the sample was small: 15 to 47 years.

There was no reasoning for the selection of the 30 minute “minimal

handling time” Unfortunately, a number of patients died shortly after the

measurements were taken. May limit validity of results as well as suggests confounding factors

affecting result. Did not try to explain why patients with worse outcomes

were not as affected by the collar.

Agrees with consensus guideline that collar application should be minimized.

13.5

DODD, SIMON, 1995

ANAESTHESIA

THE EFFECT OF A CERVICAL COLLAR ON THE TIDAL VOLUME OF ANAESTHETIZED ADULT PATIENTS

Prospective

observational

Analyze the effect of a semi rigid cervical collar on tidal volume and airway patency in patients.

A correctly fitting collar has no effect on the airway, however an ill-fitting one does. Care should be taken to ensure that semi rigid collars are applied properly, particularly in unconscious patients.

Lack of follow up of patients included in the study. Assumption that anaesthetized patients are comparable to trauma patients with altered level of consciousness. Tidal volume only measured once per position. Relies on the ability of one investigator to achieve accurate results. Investigator bias in recording results. Disproportionate number of females to males in study. Only used one type of cervical collar to measure results, Order of measurements on the patient were randomized to minimize measurement bias.

Highlights negative impact of cervical collars. Agreement with consensus “cervical collars are not the panacea they are often made out to be”

13

DAVIES ET AL, 1993

INJURY

THE EFFECTS OF A RIGID COLLAR ON INTRACRANIAL PRESSURE

Prospective,

observational

Analyse the effects of a Stiffneck cervical collar on intracranial pressure on injured patients

ICP increased significantly, yet mean arterial pressure did not, suggesting that Stiffneck cervical collars increase ICP by distorting venous drainage. Alternative forms of neck

Study sample may have been limited by different mechanisms that may not represent the population of trauma victims targeted by the study. Small sample of 19 patients. Many exclusion criteria (e.g.ICP>30mmHg, changes in ventilation during the study period). May have made the sample population less representative of the population (attrition bias). Collar fitting was only checked by one individual. Consensus with a second person would have helped to eliminate measurement bias. Only the Stiffneck collar was used, however this was explained as being due to its popularity. Explained the definition used for “increased ICP”

Agrees with consensus guideline that collar application should be minimized.

13

34 | P a g e

immobilization should be considered.

Effects of cervical collars: Summary of results

Two prospective studies investigated the effects of cervical collars on the ICP of patients.

Laerdal cervical collars were found to increase ICP by a mean of 4.4.mmHg. Stiffneck collars

were also found to increase ICP without affecting mean arterial pressure, suggesting that the

increase is due to the collar causing distortion of neck veins. In clinical practice, the cervical

collar should be removed as soon as possible. Research into suitable alternatives should be

carried out (Mobbs et al. 2002), (Davies et al 1993).

One prospective observational study found that a semi rigid collar lowers the tidal volume of

anaesthetised patients if the collar itself is ill-fitting. Care must be taken to ensure the collar is

fitted properly on unconscious patients (Dodd et al. 1995)

35 | P a g e

Selective Immobilisation

REFERENCE

JOURNAL

TITLE

DESIGN

PURPOS

E

RESULTS COMMENTS AGREEMENT WITH

CONSENSUS

STATEMENT

RATING/20

VALLAINCOURT 2009


THE OUT-OF-HOSPITAL VALIDATION OF THE CANADIAN C-SPINE RULE BY PARAMEDICS.

Prospective cohort

Determine if the Canadian C Spine rule could be implemented in emergency medical service with efficacy and safety

The Canadian C-spine rule achieved 100% sensitivity, lowering the number of unnecessary spinal immobilization by 37.7%

The three regions examined in the study (Ontario, Nova Scotia and Alberta) may not reflect the whole population of interest. Paramedics selected volunteers themselves. May introduce a selection bias. Patients used in the study were a convenience sample. May introduce selection bias. Nova Scotia patients were required to give written consent to participate, however the other regions didn’t. This may affect the results from that region. Some patients were unable to be followed up by telephone call. Some patients were not instructed to rotate their neck when the protocol indicated it, due to paramedics not agreeing with it. Paramedics may not have included some patients, giving potential for missing information. Explained the terms used “stable” “alert” and “co-operative.” The nurse following up subjects was blinded to the intervention the patient received.

Agreement with consensus statement calling for increased dissemination of selective immobilization,

15

DOMEIER 2005


PROSPECTIVE PERFORMANCE ASSESSMENT OF AN OUT-OF-HOSPITAL PROTOCOL FOR SELECTIVE SPINE IMMOBILIZATION USING CLINICAL SPINE CLEARANCE

Prospective

cohort

Determine if a selective spinal immobilization protocol can be implemented efficiently and safely.

The customized selective assessment criteria reached 92% sensitivity and 40.5% specificity. None of the non-immobilized patients sustained spinal cord injury.

The method or extent of training of emergency services personnel on using the selective criteria was not described. Only patients documented as having a spinal injury by paramedics were included in the study. Does not document patients who have spinal injury but were missed. Patients who died on the way to hospital were excluded from the study. However all patients who died except for one were immobilized. Patient outcomes may be influenced by time taken for ambulance to arrive as well as whether an ambulance or a first response unit (non-transporting) arrives before the ambulance. These factors may confound results. The study relied on patient hospital records that may contain errors or may be missing information. Records missing data were excluded, minimsing bias. An explanation was given for “spine injury”

Agreement with consensus statement calling for increased selective immobilization

14

36 | P a g e

CRITERIA

STROH, BRAUDE 2001


CAN AN OUT-OF-HOSPITAL CERVICAL SPINE CLEARANCE PROTOCOL IDENTIFY ALL PATIENTS WITH INJURIES? AN ARGUMENT FOR SELECTIVE IMMOBILIZATION.

Retrospective chart

review

Test the Fresno/Kings/Madera selective spinal immobilization protocol and its ability to identify patients with cervical spine fracture.

The test was 99% sensitive, implying the protocol could be safely used in the pre-hospital setting

There was no explanation to the choices of data sources to search. Study was retrospective, relying on a body of data with potential missing records, affecting the validity of results. Fresno county may not represent the population at large. Charts were reviewed by two authors (however it is not specified whether they do this independently.


15

HOFFMAN 2000

NEW ENGLAND JOURNAL OF MEDICINE

VALIDITY OF A SET OF CLINICAL CRITERIA TO RULE OUT INJURY TO THE CERVICAL SPINE IN PATIENTS WITH BLUNT TRAUMA. NATIONAL EMERGENCY X-RADIOGRAPHY UTILIZATION STUDY GROUP.

Prospective

Observational

Study

To prove the sensitivity of the NEXUS criteria on a large scale.

The criteria was used on 34,069 patients. NEXUS found to have missed cervical fracture in 8 out of 818 patients, showing sensitivity approaching 100%.Reduced radiographs by 12.6%, not the expected third. This may be due to influences of previous NEXUS studies.

Teaching criteria not standardized. May not have been sufficient to allow physicians to use NEXUS correctly. Did not address the lack of specificity of the NEXUS criteria. Bias of the liaison physician in charge of the group could affect how the study was carried out at each center and how data was recorded. A radiologist ensured thorough recording and collection of appropriate data for the study, minimizing missing data. Only when data forms were complete did patients go on to have radio imaging.


14.5

Selective Immobilisation: Summary of results

37 | P a g e

The efficacy of selective immobilisation in pre-hospital care was investigated in 4 studies.

Two studies, (Domeier et al. 2005) and (Stroh et al. 2010), used selective immobilisation

protocols designed for the purpose of their investigations. These were found to be highly

sensitive (99% and 92% respectively) indicating their safety for use in the pre-hospital

setting.

The validity of the NEXUS criteria was investigated on a large scale in one prospective

observational study (Hoffman et al. 2000). It was found that out of 34,069 patients, the

criteria missed 8 out of 818 cervical fractures, indicating a sensitivity approaching 100%.

Many of the missed cervical fractures were explained to be due to incorrect application of

the NEXUS criteria. These criteria did not reduce radiographs as much as expected (12.6% as

opposed to 33%), however the authors explained this difference as due to influence from

earlier studies leading to a decrease in radiographs overall.

One multiple region prospective cohort study, (Vaillancourt et al. 2009), sought to validate

the CCSR in the out-of-hospital setting by paramedics. The study claimed that the sensitivity

of the CCSR was 100%, and had lowered unnecessary immobilisations by 37.7%, suggesting a

higher specificity than other protocols. However the paramedics in the study had an

influence on the patients recruited in the study, and some patients were lost to follow up

which may have led to selection and reporting bias.

38 | P a g e

Extrication

REFERENCE

JOURNAL

TITLE

DESIGN

PURPOSE

RESULTS


CONSENSUS STATEMENT

RATING/20

DIXON ET AL 2014

EMJ

BIOMECHANICAL ANALYSIS OF SPINAL IMMOBILISATION DURING PRE-HOSPITAL EXTRICATION: A PROOF OF CONCEPT STUDY

Observational study

Determine which technique of extrication provides the least movement of the cervical spine from the neutral in line position. Study uses a healthy volunteer and biomechanical sensors in a simulated extrication scenario. Examines 9 different extrication techniques.

Subject self extrication with verbal instruction lead to an average degree of movement less than any other technique. Other techniques recorded up to 4 times more cervical spine movement than self extrication. Further evaluation of currently used extrication techniques are required.

There was only one test subject used for the entirety of the study. This individual, as a member of the same emergency services, may have had a better understanding of extrication than the average crash victim, and thus be able to follow verbal instruction to a better degree. The list of extrication techniques evaluated was influenced by the emergency team involved in the experiment. This may have increased or decreased the applicability of the test results to the larger population, depending on whether the techniques examined are utilised widely amongst extrication crews. Details of the rationale behind camera positioning and measurements used were not provided. Degree of accuracy of measuring equipment was not provided. This would influence the significance of the results. The number of repeats of each extrication procedure, in order, was not specified.

Agreement with Consensus Guidelines in that self extrication is advisable as the technique to minimise head movement.

14

BEN GALIM 2010

THE JOURNAL OF TRAUMA

Biomechanical study

on fresh cadaver

s.

To evaluate the effects of extrication collar bracing on the severely

Application of the Ambu Perfit Ace cervical collar caused

Nine cadavers used. Small sample that may not reflect population or tissue in live subjects (however cadavers were stored in such a way so as to replicate unconscious volunteers) Sample was aged 64-88 years old, and had 6 females to 3 males. The

Supports consensus guidelines on cervical collars,

13

39 | P a g e

EXTRICATION COLLARS CAN RESULT IN ABNORMAL SEPARATION BETWEEN VERTEBRAE IN THE PRESENCE OF A DISSOCIATIVE INJURY.

injured cervical spine.

an extension of the neck, leading to a separation of 7.3mm (4.0mm SD) between C1 and C2. Collars may not be offering optimal stabilization, but instead push the head away from the neck.

demographics may not represent the population of interest and may introduce bias in the study. Cause of death was not given for the cadavers, which may have confounded results. Surgically created lesion may not have been the same for each each subject, leading to bias. Surgically created lesions may not have replicated a normal injury. No description of quality control of appliance of collars. This leads to the possibility that they may not have been fitted properly. Experimenters changed their imaging technique after the first 4 cadavers to obtain better images, but did not go back to do the first four measurements again with the new imaging technique, possibly leading to significant measurement bias (however the results of both imaging techniques were viewed individually in the results section). There was only one collar used in the study, which may not reflect the outcomes for other collars used. The normal unconscious muscle tone in live patients can’t be replicated by a cadaver, confounding ability to apply results to population. Did not explain in detail the relation between the pushing of the head from the shoulders and the implications for patient outcomes. Collars were applied according to EMS protocol.

and may lend support to the concept of self-extrication.

BELBIN, 2009

UNPUBLISHED LITERATURE

A COMPARISON OF A NEW EMERGENCY EXTRICATION DEVICE (RESQROLL)

Volunteer based

experiment and

questionnaire

To compare the ResQRoll to spinal board and manual extrication in terms of speed and ease of use in extricating a simulated 70kg unconscious male from a car.

The ResQRoll was determined to be slower than the other two methods, but easier to use, and selected as the preferred method by study participants.

32 Scottish medical students of different years contacted by email and face to face interview. May not be randomized, small sample and medical students may have varying levels of expertise. The ResQRoll was demonstrated beforehand, but not the other two techniques, may introduce experiment bias. Simulated casualty was instructed to appear unconscious and unresponsive, but may not have consistently been able to do so. The cervical collar size for the patient was known for use in the spinal board and manual extrication techniques. This affects the time taken for these two methods compared to the ResQRoll. Fatigue may have factored into the later extrications in the study, affecting the results. This study does not evaluate the stabilization provided by the ResQRoll, or its safety or side effects, which are important factors to facilitate its use. The study randomized participants to different groups, lowering potential for bias. It was specified when the stopwatch was started and stopped for measuring time for procedure.

Indicates agreement with consensus statement with regards to requirement for further research into different methods of immobilization for the unconscious patient. The consensus, guidelines however, indicate that in some circumstances a conscious patient may be

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invited to self-extricate, though conscious patients were not investigated in this study.

Extrication: Summary of results

Two studies investigated the efficacy of extrication of patients as part of phSI.

The ResQRoll as an extrication tool was investigated in one experiment, (Belbin 2009), and

found to be slower than manual extrication and long spinal board extrication on an

unconscious patient. However, the size of the collar for the patient was already known, taking

away from the time taken in the long board and manual extrication studies. ResQRoll was

reported to be the preferred method by participants of the study, suggesting a high potential

for efficient use.

Dixon et al published a biomechanical study in 2014 examining the degree of neck movement

elicited in numerous extrication techniques of a healthy volunteer from a car and found that

self extrication produced the least movement of the head and neck. This supports the Faculty

of Pre-Hospital Care consensus on self extrication being the ideal means of extrication from a

vehicle with regards to neck injury.

Another study investigated the efficacy of cervical collars in extrication by measuring

distraction in experimental lesions in cadavers. It was found that the Ambu Perfit Ace cervical

collar lead to pushing the head away from the shoulders leading to a distraction of the cervical

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vertebrae (mean separation of 7.3mm). It was theorised that this may lead to worse patient

outcomes than if no collar was applied at all.

Other aspects of immobilisation

REFERENCE

JOURNAL

TITLE

DESIGN

PURPOSE

RESULTS


CONSENSUS

STATEMENT

RATING/20

BRUIJNS, GULLY, WALLACE, 2013


EFFECTS OF SPINAL IMMOBILISATION ON HEART RATE, BLOOD PRESSURE AND RESPIRATORY RATE

Prospective

unblinded repeated measure

study

To determine the effect of spinal immobilization, and techniques such as log roll, on heart rate, respiratory rate and blood pressure.

The interventions examined lead to a significant increase in pain however heart rate, blood pressure and respiratory rate remain unaffected. In the clinical setting, a change in these signs should not be assumed to be due to immobilization. This may indicate

Only healthy volunteers were used. Subjects were recruited from hospital staff. This may not reflect the population the study is aimed at. Subjects that developed symptomatic bradycardia, tachycardia or hypertension during data collection were excluded. This could lead to attrition bias. Subjects were only on the board for ten minutes, which did not reflect average transport times, which are, on average, longer. Subjects were in a relaxed environment and were familiar with the procedure. This does not reflect the scene of an accident, where anxiety could affect heart rate, blood pressure etc. The study used repeated measures to improve reliability. A power value of 80% was included in the study to quantify the validity of the results. Subjects were excluded if they could have confounded results, improving the reliability of the conclusion. A visual analogue scale was used to quantify measurements of distress and pain, which is as objective as possible.

Agrees with consensus guideline observation that spinal immobilization may complicate clinical findings, and highlights the need for more research to be carried out.

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that immobilization can indirectly lead to a confounding of clinician’s interpretation of the trauma victim’s presentation.

AY, AKTAS 2011

TURKISH JOURNAL OF TRAUMA AND EMERGENCY SURGERY

EFFECTS OF SPINAL IMMOBILIZATION DEVICES ON PULMONARY FUNCTION IN HEALTHY VOLUNTEER INDIVIDUALS

Cross-over trial

Examine the effects of spinal immobilization on pulmonary function.

Kendrick Extrication Device (KED) and long spinal board cause a decrease in pulmonary function. This effect is made worse the longer immobilization continues.

Healthy volunteers used, may not reflect outcomes for trauma patients. The method behind recruitment of volunteers was not explained. Experience with spirometry tests may effect results and lead to bias. This was not investigated in patients. The effects of the KED without the Philadelphia cervical collar were not investigated. Only the Philadelphia type collar was investigated. The reasoning behind using an hour’s rest time was not explained. Participants were not allowed to join the study if they had any chronic disease, respiratory tract infection or failed to take a spirometry test. This prevented confounding factors from affecting study results. This was confirmed with an exam.

Confirms consensus statement observation that immobilization can lead to a decrease in pulmonary function.

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DEL ROSSI 2008

JOURNAL OF ATHLETIC TRAINING

THE 6-PLUS-PERSON LIFT TRANSFER TECHNIQUE COMPARED WITH OTHER METHODS OF SPINE BOARDING.

Crossover study

To compare log roll, lift and slide and 6 plus person lift as spinal board transfer techniques in terms of minimizing cervical spine movement on fresh cadavers with artificially placed unstable spinal segments.

There is movement with all spinal board transfer techniques, but it is minimised with lift and slide as well as 6 plus person lift techniques.

Cadaver study, may not accurately reflect living patients. Lesion created was uniform. May not reflect other possible injuries. Experienced physician was leading the techniques each time. May introduce bias as the physician is likely to have a different skill set to the EMS personnel. Number of cadavers used in the study was small (5). May not be sufficient to derive reliable conclusions. Age of cadavers’ average approximately 82 years old. Aged tissue is less mobile than young tissue, which is important given that traumatic spinal injury occurs primarily in the young. Participants in the study were trained professionals, increasing the probability that movement techniques were carried out correctly. Detailed descriptions present of manual techniques and measurement methods. Described the author’s interpretation of unstable spinal injury.

Evidence of other techniques as suitable replacements to log roll. The consensus statement describes log roll as “detrimental.”

13.5

HAUSWALD, ONG ET AL 1998

ACADEMIC EMERGENCY MEDICINE

OUT OF HOSPITAL SPINAL IMMOBILIZATION; ITS EFFECT ON NEUROLOGIC INJURY

5 year retrospe

ctive chart

review

Compare rate of disabling neurologic injury in blunt trauma patients in Malaysia (do not immobilize) vs New Mexico (immobilize)

Significantly higher rates of disabling neurologic injury in New Mexico than Malaysia. Puts efficacy of spinal immobilization into question.

Retrospective study may lead to omissions of data in the study. Malaysian and U.S included and excluded different patients, leading to inconsistencies. ED staff in Malaysia could not remember any patient who came in under phSI, however this does not mean that no one did. Injury severity patterns were not examined due to insufficient data in Malaysia. One area may have had overall worse injuries than the other. Sample size of patients in Malaysia may not be enough to derive a relationship reliably. Different mechanisms of injury between the two locations may mean that there is a difference in requirement for immobilization. Patients admitted after 1990 were treated with high dose methylprednisolone in both countries, which may act as a confounding factor. Patients who died in the ambulance were only excluded from the study if their death was unrelated to spinal injury; however this is a subjective decision. “Neurologic injury” was defined.

Does not comment on changing protocol, but highlights the requirement for further study into the efficacy of phSI, which the consensus guidelines also indicate.

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MAZOLEWSKI, MANNIX, 1994


THE EFFECTIVEN

Randomized block

experimentation

To determine experimentally how well lateral movement is reduced for volunteers strapped to a backboard.

Methods of immobilization still allow for lateral movement. An additional abdominal strap reduced lateral movement by 26%.

The measurements for lateral placement were not carried out repeatedly. There may have been inaccuracies as a result. A small sample of 19 people were used. Only males were attached to the apparatus due to anatomical difficulties applying the measuring chest piece. The results obtained may not reflect those obtained from a study with both men and women included. Only people with a height below 6 ft were used. This may lead to attrition bias. The tightness of the straps was determined by the patient’s ability to

Agreement with the consensus statement in terms of there being a requirement for further research and audit of current

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ESS OF STRAPPING TECHNIQUES IN SPINAL IMMOBILIZATION

breathe. This is subjective to the patient’s level of discomfort, and would affect how securely patients were strapped. Accuracy of the novel measuring technique (to measure lateral movement) was determined to allow for more reliable results. The physical characteristics of the participants were documented to minimize bias.

practice.

Other aspects of immobilisation: Summary of results

A crossover study of manual spinal board transfer techniques on cadavers found that all

techniques lead to some degree of spinal movement (Del Rossi et al. 2008)

The effects of immobilisation on vital signs was carried out under the hypothesis that the

painful and stressful nature of the procedure may affect respiratory rate, heart rate and blood

pressure. However, the results show that this is not the case. Bias in this study may have

been introduced as the participants were healthy hospital workers, who may not have been

affected by the procedure as much as real patients (Bruijns et al. 2013).

Another study on healthy volunteers found that immobilisation devices such as the spinal

board and KED lower pulmonary function (Ay et al. 2011).

An experiment on healthy volunteers found that standard strapping techniques used in phSI

allow for a degree of lateral movement. The study proposed an additional strap that was

found to minimise this movement (Mazolewski & Manix 1994).

A five year retrospective chart review, (Hauswald et al. 1998), compared the neurological

outcomes of blunt trauma patients in New Mexico (where full phSI is standard in these

patients) and Malaysia (where, at the time of the study, there was no EMS system in place,

and so no phSI). It was found that patients in New Mexico suffered worse neurological

outcomes compared to Malaysia. There were a number of weaknesses to the study,

particularly the differences between patient populations in the two locations. Furthermore, the

retrospective nature of the chart review could have lead to missing information, affecting its

validity. Nevertheless, this study calls into question the efficacy of phSI in reducing adverse

neurological outcomes. It also proposes the idea that phSI may be contributing to increased

patient morbidity and mortality.

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