BJA Advance Access originally published online on July 31, 2009
British Journal of Anaesthesia 2009 103(3):371-386; doi:10.1093/bja/aep202
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Pre-hospital tracheal intubation in patients with traumatic brain injury: systematic review of current evidence
1 German Cochrane Centre, Department of Medical Biometry and Statistics, University Medical Centre Freiburg, Stefan-Meier-Strasse 26, D-79104 Freiburg, Germany
2 Swiss Paraplegia Research, Nottwil, Switzerland
3 Department of Anaesthesiology, University Hospitals of Vaud, Lausanne, Switzerland
4 Division of Anaesthesiology, University Hospitals of Geneva, Geneva, Switzerland
5 Emergency Department, St Gallen Cantonal Hospital, St Gallen, Switzerland
* Corresponding author. E-mail: vonelm{at}cochrane.de
Accepted for publication May 14, 2009.
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Abstract |
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Background: We reviewed the current evidence on the benefit and harm of pre-hospital tracheal intubation and mechanical ventilation after traumatic brain injury (TBI).
Methods: We conducted a systematic literature search up to December 2007 without language restriction to identify interventional and observational studies comparing pre-hospital intubation with other airway management (e.g. bag-valve-mask or oxygen administration) in patients with TBI. Information on study design, population, interventions, and outcomes was abstracted by two investigators and cross-checked by two others. Seventeen studies were included with data for 15 335 patients collected from 1985 to 2004. There were 12 retrospective analyses of trauma registries or hospital databases, three cohort studies, one case–control study, and one controlled trial. Using Brain Trauma Foundation classification of evidence, there were 14 class 3 studies, three class 2 studies, and no class 1 study. Six studies were of adults, five of children, and three of both; age groups were unclear in three studies. Maximum follow-up was up to 6 months or hospital discharge.
Results: In 13 studies, the unadjusted odds ratios (ORs) for an effect of pre-hospital intubation on in-hospital mortality ranged from 0.17 (favouring control interventions) to 2.43 (favouring pre-hospital intubation); adjusted ORs ranged from 0.24 to 1.42. Estimates for functional outcomes after TBI were equivocal. Three studies indicated higher risk of pneumonia associated with pre-hospital (when compared with in-hospital) intubation.
Conclusions: Overall, the available evidence did not support any benefit from pre-hospital intubation and mechanical ventilation after TBI. Additional arguments need to be taken into account, including medical and procedural aspects.
Keywords: airway; brain, injury; complications, intubation tracheal; ventilation, mechanical
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Introduction |
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Traumatic brain injury (TBI) is a major burden for societies.1 Despite considerable resources being invested in acute medical care and rehabilitation, many survivors have permanent disability. In a recent cohort study, 53% of patients admitted to hospital with severe TBI died within 6 months, whereas 17% had unfavourable outcomes and only 29% favourable outcomes after 6 months.2
In most developed countries, pre-hospital care is performed by trained teams of out-of-hospital emergency services (OHEMS). Their principal tasks in patients with suspected TBI are, first, to provide basic or advanced life support at the scene to reduce secondary brain injury,3–5 and secondly, to transport the patient to an adequate health-care facility within the so-called ‘golden hour’.6 At present, early tracheal intubation and mechanical ventilation are accepted standards of care in patients with severe TBI. These interventions help prevent cerebral hypoxia and increased intracranial pressure due to uncontrolled hypercapnia and resulting cerebral vasodilatation. Both these mechanisms can lead to cerebral oedema and secondary brain injury. Tracheal intubation can prevent airway obstruction and aspiration of gastric contents when protective airway reflexes are absent. However, tracheal intubation can also be harmful. If performed in unfavourable settings and by unskilled staff, failure and resulting oxygen desaturation are more likely. Intubation on scene may increase the risk of early onset pneumonia.7 Hyperventilation during the pre-hospital period can aggravate cerebral ischaemia and secondary brain injury with increased mortality.8 Mechanical ventilation with uncontrolled positive pressure may reduce venous return from the cerebral circulation and increase cerebral oedema. Hence, it is controversial whether patients with severe TBI always benefit from pre-hospital intubation and mechanical ventilation. We aimed to review the current research evidence on benefit and harm of pre-hospital intubation and mechanical ventilation in patients with TBI.
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Methods |
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Systematic literature search
Two investigators (E.v.E. and B.W.) independently conducted literature searches for relevant studies of all designs in Medline, Embase, CINAHL, and the Cochrane Library without language restrictions. We used a sensitive systematic search strategy combining the free text and thesaurus terms ‘traumatic brain injury’, ‘head injury’, or ‘head trauma’ with ‘intubation’, ‘ventilation’, ‘pre-hospital’, ‘out-of-hospital’, or ‘emergency’. We included full publications published up to December 2007; meeting abstracts or letters were excluded. Bibliographies of retrieved reports and of relevant review articles were checked for additional articles.
We included studies if they compared patients with TBI receiving tracheal intubation and mechanical ventilation before hospital admission with those receiving other types of pre-hospital airway management. Studies were eligible, if they reported on patient-relevant endpoints such as mortality or functional outcome (e.g. Glasgow outcome scale) at the time of hospital discharge or later; studies reporting only on surrogate endpoints were excluded. Studies of patients with multiple injuries were included, if data on a well-defined subgroup of TBI patients were reported. Two reviewers (E.v.E. and B.W.) screened search results, retrieved eligible papers, and decided on study inclusion.
Data abstraction and outcome definitions
Data were abstracted by two investigators (I.H. and E.v.E.) and cross-checked by two others (B.W. and P.S.). We classified abstracted study outcomes as either benefit or harm outcomes. Benefit outcomes were reduction of mortality during the in-hospital period or later and ‘good outcome’ as defined by discharge destination or a scoring instrument. Harm outcomes were potential side-effects or complications of the intubation including procedure failure and ventilator-related pneumonia. Prolongation of the pre-hospital period due to field intubation was classified as harm outcome. If outcome data (e.g. for functional outcome) were dichotomized, we extracted the data as reported by the investigators. If outcomes were reported at several time points, we used data of the latest time point after injury. Disagreement on data abstraction was resolved by consensus. We assessed the relevance of each benefit and harm outcome for patients' life after TBI using elements of the GRADE methodology and classified them as ‘critical’, ‘important’, or ‘not important’.9
Assessment of study quality
We assessed the methodological quality of included studies using the classification of evidence developed by the Brain Trauma Foundation.10 We distinguished three classes of evidence: (i) good quality randomized controlled trial; (ii) moderate quality randomized controlled trial, good quality cohort study, or good quality case–control study; (iii) poor quality randomized controlled trial, moderate or poor quality cohort study, moderate or poor quality case–control study, case series, database- or registry-based study. Two investigators (B.W. and P.S.) independently classified each included paper; discrepancies were resolved by consulting a third reviewer (E.v.E.). We defined a priori two areas of potential study heterogeneity and extracted key information from each included study: (i) characteristics of study participants including age, severity of TBI assessed by Glasgow coma scale (GCS) or abbreviated injury score (AIS) for the head, or severity of all injuries assessed by injury severity score (ISS); and (ii) medical care during pre-hospital period including qualification of staff, intubation technique, rapid sequence induction (RSI), and ventilation parameters.
Data analyses
We calculated unadjusted odds ratios (ORs) and absolute risk differences (ARDs) with 95% confidence intervals (CI), if binary data were available. We defined OR >1 and ARD >0 as effects in favour of pre-hospital intubation and plotted forest plots for unadjusted effect estimates. We refrained from pooled data analyses because the designs, populations, and settings of included studies were heterogeneous and because we could not fully elucidate to what extent the same data were included in several reports for some studies. Forest and L'Abbé plots were drawn using STATA 9.
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Results |
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Included studies
We examined the abstracts of 252 reports and read 35 articles in full. Eighteen were subsequently excluded (Fig. 1): of those, eight had a different scope11–18 and four reported on irrelevant endpoints.19–22 Four studies did not define distinct subgroups of TBI patients.23–26 Two reports19 27 were excluded because they used the same registry data as one of the included studies.28 We eventually included 17 articles published between 1997 and 20077 28–43 reporting on patient data collected between 1985 and 2004.
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Thirteen studies were conducted in the USA, and four in Europe (Table 1). Of the US studies, seven were from California, and of those five from San Diego County (with overlapping periods of data collection). In total, data for 15 335 patients were analysed. The size of study groups with pre-hospital intubation ranged from 21 to 1929 (median, 268), and of the comparison groups from 25 to 2301 (median, 276). Six studies28 30 35 38–40 were in adults, five29 32 34 37 43 in children, and three in both7 33 42 (Table 2). In two studies, the number of children included was unclear;36 41 in one, age was not specified.31
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Using criteria of the Brain Trauma Foundation.
Participants evaluated for pneumonia. 
Participants evaluated for ICU and 90 day mortality
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Assessment of study quality
Study design and classification of evidence
There were 12 retrospective analyses of trauma databases, registries, or hospital files,7 28–31 33 34 37–39 41 42 three cohort studies,36 40 43 one case–control study,35 and one controlled trial with treatment allocation by alternating date32 (Table 1). Of the database studies, eight28 31 33 34 37–39 42 used trauma registries and four7 29 30 41 hospital files. Two cohort studies40 43 and the case–control study35 had a historical control group. Using the Brain Trauma Foundation classification, we regarded 14 included studies7 28–31 33 34 36–39 41–43 as class 3 evidence and three studies as class 2 evidence (Table 1).32 35 40 There was no class 1 evidence. In six studies,33 36 38 39 41 42 the two reviewers' judgement on evidence classes differed and the final classification was made by consulting a third reviewer.
Patient characteristics
Patient characteristics were used for statistical adjustment of results in seven of 16 studies with mortality estimates, and in two of six studies reporting on functional outcome measured by a score. None of the included studies adjusted any estimates of harm outcomes. Overall, 13 articles included group-specific age information; the mean or median age of patients ranged from 1.032 to 44.840 yr in the intubation groups, and from 1.232 to 42.540 yr in the control groups (Table 2). In two studies,30 36 the comparison groups differed in age by 5 yr or more; none adjusted for age. In 10 studies with group-specific information on neurological status, the mean or median initial GCS ranged from 3.031 33 to 5.230 in the intubation groups, and from 4.428 to 8.07 28 in the control groups. In four studies,7 28 29 40 the groups differed by one GCS point or more. One study adjusted for GCS,40 another29 did not. Adjustment for GCS was unclear in one study28 and was not reported for the TBI subgroup in another.7 In 10 studies with group-specific information on the severity of TBI, the mean or median AIS of head region ranged from 3.27 to 5.129 in the intubation groups, and from 2.77 to 5.031 in the control groups. The maximum difference between the study groups in a single study was 0.5 AIS points. Two studies30 43 were restricted to isolated TBI. In 10 studies with group-specific information on the overall severity of injury, the mean or median ISS ranged from 20.136 to 39.829 in the intubation groups, and from 187 to 3531 in the control groups. In three of these studies,7 28 29 the difference between the groups was 5 ISS points or more. Adjustment for ISS was not done in one study,29 unclear in another,28 and not reported for the subgroup of head-injured patients in yet another study.7
Pre-hospital intubation and mechanical ventilation
In four articles,32 35 36 40 pre-hospital intubation and ventilation protocols were described in detail. In two studies, paramedics received specific training within the study's framework for 632 and 8 h,35 respectively. RSI was performed in all field-intubated patients in four studies30 35 36 40 and partly in three studies.29 31 38 In one study,33 patients were intubated without prior medication. The remaining nine reports7 28 32 34 37 39 41–43 did not mention medication for intubation.
Four studies specified the pre-hospital airways management in the control group as bag-valve-mask ventilation32 34 35 or spontaneous breathing.41 None provided data on the inspired oxygen concentration used. The pre-hospital airway management of control groups was unclear in the remaining 13 studies. However, five studies7 30 36–38 mentioned that patients were intubated at hospital arrival. Two studies29 37 distinguished between intubation in trauma and non-trauma centre hospitals, and another33 between successful and attempted intubation.
Two study reports35 43 described pre-defined goals for mechanical ventilation after successful intubation for all or part of included patients, but none reported on the chosen inspired oxygen fraction level. Five studies32 35 36 40 41 reported on measured respiratory parameters: three36 40 41 on oxygen saturation at baseline or time of hospital admission or both; one32 on median oxygen saturation; and one35 on arterial blood gases measured at hospital admission. Hyperventilation was described in two studies: 6% of intubated patients were hyperventilated in one study41 and all patients with signs of clinical deterioration in another.40 No study mentioned hypoventilation.
Relevance of study outcomes
We assessed the relevance of the reported outcomes for our research question.9 Most studies reported on mortality during hospital stay. For mortality estimates, only one study41 used a fixed time interval of 90 days, which exceeded an average length of hospital stay for TBI. We deemed ‘in-hospital mortality’ a critical outcome. After current recommendations on TBI research,44 we considered functional outcome another critical outcome, if measured by validated scoring instruments 6 months or more after the injury. Only one study40 used such an endpoint. We regarded functional outcome at the time of hospital discharge as an important (but not critical) outcome. Discharge destination was not deemed important because it is not a valid surrogate of patients' outcome.
Harm outcomes related to pre-hospital airway management were deemed critical outcomes. However, the studies used various definitions for harm outcomes and most of them reported sparse data only.
Summary of reported study outcomes
Reduction of mortality
Fifteen studies reported mortality during the in-hospital period. None provided information on the actual length of survival after injury. In 13 studies, the unadjusted ORs for an effect of pre-hospital intubation on in-hospital mortality ranged from 0.17 (95% CI: 0.10–0.31)33 to 2.43 (95% CI: 1.78–3.33)31 (Fig. 2, Table 3). The absolute differences for in-hospital mortality risk ranged from –21.8%31 to 38.2%33 (Table 3) and the corresponding event rates from 14.3%30 to 81.5%33 for pre-hospital intubation and from 12.4%36 to 68.0%32 for other airway management (Fig. 3). The point estimates of eight studies28 29 32 33 35–38 favoured other airway management and of five studies30 31 34 39 40 pre-hospital intubation. Seven studies28 33 35 38–40 42 reported adjusted ORs for in-hospital mortality estimates ranging from 0.24 (95% CI: 0.11–0.49)33 to 1.42 (95% CI: 1.13–1.78)39 (Table 3). In most of these studies, the selected confounding factors included age, sex, and at least one measure of injury severity. In two studies, it was unclear which factors were selected for adjustment.28 35
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One study40 reported 1 and 24 h mortality. At both time points, pre-hospital advanced life support and rapid sequence intubation was superior to standard pre-hospital care without intubation (Table 3; Fig. 2). Another study41 reported mortality in the intensive care unit and after 90 days. At both time points, the control intervention was superior.
Functional outcome
Five studies3 30 31 37 38 reported functional outcome defined by destination at hospital discharge (Table 3). In two studies,31 37 good outcome was defined as discharge to home, and in three studies30 35 38 as discharge to home, rehabilitation, psychiatric facility or jail, or signing out against medical advice. None of these studies included data on the time elapsed between trauma and hospital discharge. Three studies35 37 38 reported better outcome with control interventions, and one study31 with pre-hospital intubation (Table 3, Fig. 4). One small study30 was inconclusive. In two studies, estimates were adjusted for confounding factors;35 38 both were in favour of the control interventions (Table 3).
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Six studies32 34 37 38 40 41 used scoring instruments for functional outcome. ‘Good outcome’ was defined as functional independence measure (FIM) level of 5–7;34 ‘normal’ FIM score37 (without definition of ‘normal’); modified Pediatric Cerebral Performance Category Scale indicating either normal status, no change from baseline, or mild disability,32 favourable final outcome (i.e. good recovery or moderate disability)41 or functional impairment score of 0–5 (i.e. mild impairment) on a scale ranging from 0 to 15.38 In two studies,34 40 pre-hospital intubation was superior with regard to functional outcome by score; in two others,37 38 the control groups fared better (Fig. 4). Two studies32 41 were inconclusive. One study37 stratified by severity of head injury and another38 used propensity scores for adjustment. In both, adjusted functional outcomes were in favour of the control interventions. One37 included only percentage data for functional outcomes (not shown in Fig. 4).
Harm outcomes
Seven7 30 32–36 studies reported on harmful effects of pre-hospital intubation or other airway management (Table 4). In five studies,30 32–35 the frequency of different procedure failures or complications during airway management were reported. With pre-hospital intubation, intubation failure or complication rates ranged from 2.1%30 to 41.1%35 (Table 4). Two reports30 34 included absolute numbers of intubation failures in the pre-hospital and in-hospital period; study results were inconclusive (Fig. 5). Three studies7 30 36 reported on pneumonia after pre-hospital or in-hospital intubation; it was the primary study outcome in one study.7 Diagnostic criteria were reported in two,7 36 but unclear in another.30 Pre-hospital intubation was consistently associated with increased odds of pneumonia (Table 4, Fig. 5). One study35 reported that inadvertent hyperventilation was associated with pre-hospital intubation. A paediatric study32 included data on complications of airway management for all patients (including those with other injury) and showed no difference between study groups. Seven studies29 30 32 35–37 40 included data on pre-hospital delays (Table 4). The mean or median time on scene with pre-hospital intubation ranged from 1132 to 29 min,40 and with control interventions from 932 to 27 min.40 In three studies,30 32 35 the time on scene was significantly longer with pre-hospital intubation.
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Discussion |
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We reviewed the current research evidence on the efficacy and harm of pre-hospital intubation and mechanical ventilation from more than 15 000 included TBI patients. The overall strength of this evidence was low. In many studies, we found a lack of statistical adjustment for important confounding factors and of reported detail about control interventions and harm outcomes. The reports did not show any consistent beneficial or harmful effect of pre-hospital intubation on critical outcomes.
Limitations of original studies
None of the included studies used proper randomization and therefore could not be classified as class 1 evidence. Three of 17 studies were class 2 and 14 studies class 3 evidence. It was unclear to what extent the included studies were susceptible to biases and overestimation of effects. Information on drop-outs was provided only rarely and, consequently, attrition could not be assessed. Most studies were based on already existing data sets such as trauma registries. Although such studies are often larger than experimental studies, their internal validity is often limited. Six of the studies included had <200 participants with TBI. Clearly, the small sample size limits the validity of these studies. Some included studies had long durations of data collection or used historical controls. Differences in observed effects may be due to changes in clinical practice and organization of health services over time rather than the interventions compared. Further, multi-purpose data sets often lack information on important confounders and patient-relevant long-term outcomes. Most included studies reported in-hospital mortality, but only a few on other important outcomes (e.g. functional outcome after 6 months). In some studies, data on confounding factors were collected but not used for statistical adjustment. For instance, in two studies, there was a difference in initial GCS between the intubation and the control group that was not accounted for in the analyses.7 29 Other studies were too small to allow multivariate analyses. The control groups of most studies were not sufficiently described. For instance, airway management before hospital admission was often not described for studies with intubation in the emergency department as control intervention. The data suggested that the comparison groups differed in several aspects, such as injury severity. Other important study information was given only sparsely including intubation failure rates, skills and training for intubation, monitoring of mechanical ventilation on the accident scene and during transport, and institutional characteristics including TBI patient volume of trauma centres. Some studies used outcomes with short follow-up times or variable definition (e.g. hospital discharge). However, it is inappropriate to evaluate functional outcomes or quality of life earlier than 6 months after injury.44
Strengths and limitations of our review
We used rigorous review methods to search and assess the relevant literature. Compared with earlier reviews,45 46 our literature search was more extensive and the inclusion criteria were stricter. For instance, we excluded studies on pre-hospital intubation and neuromuscular blocking16 and those without well-defined groups of TBI patients.23–26 However, we may have missed eligible studies, in particular if they were not indexed in the used literature databases or not published in full. Further, it is possible that some studies, for example, those with inconclusive results, were not published or that other reporting biases occurred. For instance, we observed that most investigations were performed in the USA, and most of them in California, while other countries were under-represented. However, we refrained from a more formal investigation of possible biases given that pooled analyses were not feasible. Our appraisal of study quality and relevance of findings was based on established frameworks.9 10 We focused on the available evidence from research studies and excluded other types of information. We extracted data on harmful effects in order to complement our review and found rates of procedure failure and pneumonia that were higher than in previously published papers.47 48 Eight of the 17 studies included children as the main study population or as a subgroup. In order to be comprehensive, we presented the available data on pre-hospital intubation in children while acknowledging that the care for very young TBI patients is specific and the trade-off between benefit and harm of intubation may be different for them.49
Clinical interpretation of findings
Given the relative uncertainty from the research, additional factors may be important in a specific clinical situation, including oxygen saturation before and after initial oxygen therapy, ventilation before and after manual clearing of the upper airway, facial trauma, and anticipated delays until definitive trauma care. A more conservative attitude towards pre-hospital intubation has been proposed in a current guideline50 and, in particular, if expected transport time is short.51 In addition, the availability of well-trained OHEMS teams with low intubation failure rates may be an argument for more permissive use of pre-hospital intubation. However, if this invasive procedure and the ensuing mechanical ventilation are performed poorly, the negative effects may outweigh potential benefits.18 There were few reports of harm from intubation in the included studies. Multiple and prolonged intubation attempts, inadequate oxygenation, or excessive ventilation can contribute to secondary brain insult. Adequate training of staff is therefore crucial and should be the subject of future quality improvement studies. Both hyper- and hypocapnia may be strong components in secondary brain insult.52 However, we emphasize that, although the effectiveness of pre-hospital intubation is uncertain, the situation may be different for other pre-hospital interventions. For instance, supplemental oxygen is recommended in recent guidelines.10
We found few studies planned explicitly to address our study question and no randomized trials. Well-designed randomized and non-randomized studies are needed to further elucidate whether, and in what circumstances, pre-hospital intubation is beneficial or harmful. Such studies could be strengthened by the following methodological features:
- recording of severity of TBI and concomitant injuries using standard classification schemes;
- clear definition and description of control interventions;
- intubation training of OHEMS staff (e.g. minimum of 60 intubations);53
- definition of organizational characteristics of participating OHEMS and hospitals, as they influence patient outcome;54 55
- reporting of patient volume of participating trauma centres (larger centres were found to have lower mortality);56
- adherence to accepted standard procedures for intubation and monitoring of harmful effects of intubation;
- collection of data on respiratory and ventilation measures including hypocarbia during the pre-hospital period; blood gas analyses at the time of hospital admission;
- documentation of delays between accident and clinical decision about neurosurgery (e.g. defined by the time of neurosurgical consultation);
- the use of validated outcome measures (e.g. extended Glasgow outcome score) at fixed and meaningful time points57 and blinding of those assessing outcomes to study interventions or important predictive factors;
- monitoring of loss to follow-up at all stages.
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