RATIONALE: According to TraumaRegister DGU (the trauma registry of the German Trauma Society), 83% of trauma patients are admitted to an intensive care unit (ICU), with 34.8% receiving mechanical ventilation. However, specific data for people with multiple trauma are lacking. Prolonged ventilation due to acute respiratory failure or difficult weaning are common indications for tracheostomy in critically ill people. Despite numerous studies, the optimal timing for tracheostomy remains unclear. This review was initiated during the development of the Association of the Scientific Medical Societies in Germany (AWMF) S3 guideline 'Intensivmedizin nach Polytrauma' (intensive care after multiple trauma) to systematically assess the effects of early versus late tracheostomy in people with multiple trauma in the ICU.
OBJECTIVES: To assess the benefits and harms of early tracheostomy compared with late tracheostomy in adults with multiple trauma in the intensive care unit.
SEARCH METHODS: We searched CENTRAL, MEDLINE, Web of Science, ClinicalTrials.gov, and WHO ICTRP from inception to 15 March 2024 without language restrictions. We also screened reference lists and contacted experts in the field.
ELIGIBILITY CRITERIA: We followed standard Cochrane methodology. We included randomised controlled trials (RCTs) and non-randomised studies of interventions (NRSIs) comparing early and late tracheostomy, defined according to any cutoff time point, in critically ill adults with multiple trauma, irrespective of sex, ethnicity, disease severity, or setting. We excluded studies published as abstract only, studies recruiting people with only one type of trauma, and studies recruiting people who needed immediate tracheostomy.
OUTCOMES: The critical outcome was all-cause mortality. Important outcomes included duration of stay (ICU or hospital), quality of life, pulmonary complications, adverse events, and time from tracheostomy to decannulation.
RISK OF BIAS: We used Cochrane risk of bias tools (RoB 2 for RCTs and ROBINS-I for NRSIs) to assess risk of bias at the outcome level.
SYNTHESIS METHODS: Our meta-analyses used a random-effects model. Our main comparison was early tracheostomy (< 10 days) versus late tracheostomy (≥ 10 days) after intubation. Because the timing of early tracheostomy varied considerably across studies, we explored the impact of different timings in subgroup analyses. We used the GRADE approach to assess the certainty of evidence.
INCLUDED STUDIES: We included one RCT (60 participants) and 22 NRSIs (44,811 participants). The RCT was a single-centre, parallel-group trial conducted in the USA over 38 months. It was halted prematurely after the first interim analysis. Most NRSIs (91%) were retrospective. Six studies, including the RCT, specifically addressed our main comparison (< 10 days vs ≥ 10 days).
SYNTHESIS OF RESULTS: Evidence from the RCT (60 participants) suggested that early tracheostomy (< 10 days) compared with late tracheostomy (≥ 10 days) may have little to no effect on all-cause mortality (risk ratio (RR) 0.43, 95% confidence interval (CI) 0.09 to 2.03; very low-certainty evidence), ICU length of stay (mean difference (MD) -0.30 days, 95% CI -17.64 to 17.04; very low-certainty evidence), or rate of pneumonia (RR 1.07, 95% CI 0.93 to 1.22; very low-certainty evidence), but the evidence for all three outcomes is very uncertain. No data were available for quality of life, adverse events, or time from tracheostomy to decannulation. NRSI data suggested that early tracheostomy compared with late tracheostomy may have little to no effect on all-cause mortality (adjusted hazard ratio (HR) 0.96, 95% CI 0.49 to 1.88) or rate of ventilator-associated pneumonia (unadjusted RR 1.10, 95% CI 0.78 to 1.56). One NRSI with adjusted data suggested that early tracheostomy may reduce ICU length of stay (1/HR 0.57, 95% CI 0.46 to 0.71), while unadjusted data from two NRSIs suggested that early tracheostomy may increase in-hospital mortality (RR 1.20, 95% CI 1.06 to 1.36; odds ratio (OR) 1.22, 95% CI 1.05 to 1.41). The evidence for all these outcomes was very uncertain. The certainty of the evidence was consistently rated as very low across outcomes. The most common reason for downgrading was imprecision, due to small sample sizes, wide CIs including both benefit and harm, and analyses including data from only one study. In NRSIs, additional downgrades were due to serious risk of bias, particularly related to potential confounding and unclear adjustment for baseline differences. We identified one ongoing trial.
AUTHORS' CONCLUSIONS: Early tracheostomy (< 10 days after intubation) may have little to no effect on all-cause mortality, ICU length of stay, or rate of pneumonia compared with late tracheostomy (≥ 10 days), but the evidence is very uncertain. No data were available on quality of life, adverse events, or time from tracheostomy to decannulation. Adjusted NRSI data suggest that early tracheostomy may reduce ICU length of stay, but the evidence is very uncertain. Given the limited RCT data and the heterogeneity of NRSIs, future research should focus on standardising definitions of multiple trauma and timing of tracheostomy, while also addressing equity by including diverse populations and settings. More high-quality studies are needed to confirm possible benefits of early tracheostomy, with particular attention to adjusted analyses and outcomes such as mortality, ICU length of stay, and pulmonary complications. Further studies should also explore the long-term effects of tracheostomy on survival, quality of life, and functional outcomes to guide evidence-based clinical decision-making in multiple trauma care.
FUNDING: Internal funding.
REGISTRATION: Protocol: doi.org/10.1002/14651858.CD015932.
