Important Trials on Tracheostomy in the ICU
The most significant trials examining tracheostomy timing in ICU patients are referenced in a Cochrane systematic review of nearly 2,000 patients, which demonstrated that early tracheostomy (performed at 10-15 days) reduces mortality with a number needed to treat of 11 compared to late tracheostomy or prolonged intubation. 1
Key Landmark Trials Referenced in Guidelines
Timing of Tracheostomy Trials
The French Intensive Care Society guidelines reference several good-quality prospective studies that examined objective criteria including mortality, ventilator-associated lung injury, duration of mechanical ventilation, and ICU length of stay when comparing early versus late tracheostomy. 2 These trials consistently showed that early tracheotomy (generally before the fourth day of mechanical ventilation) was not associated with decreases in mortality, ventilator-associated lung injury, or duration of mechanical ventilation, though it did reduce consumption of hypnotic drugs. 2
A more recent 2015 systematic review and meta-analysis published in The Lancet Respiratory Medicine analyzed 13 trials with 2,434 patients and 648 deaths, finding that early tracheostomy (within 1 week) did not significantly lower ICU mortality (OR 0.80,95% CI 0.59-1.09; p=0.16) but did reduce ventilator-associated pneumonia incidence (OR 0.60,95% CI 0.41-0.90; p=0.01). 3
A 2024 systematic review and meta-analysis in Life included 19 RCTs covering 3,586 critically ill patients and found that early tracheostomy modestly decreased mortality (RR -0.1511, p=0.0398), reduced ICU length of stay (SMD -0.6237, p=0.0002), and shortened duration of mechanical ventilation compared to late tracheostomy (SMD -0.3887, p=0.0472). 4
Technique Comparison Trials
Several randomized studies compared percutaneous versus surgical tracheotomy techniques, examining complications (short-, medium-, and long-term), mortality, and cost. 2 A 2014 meta-analysis including 14 randomized studies found that percutaneous technique was associated with shorter operative time and decreased incidence of stoma infection and inflammation, though neither technique proved superior for mortality or major complications. 2
One randomized prospective study specifically compared surgical tracheotomy with modified percutaneous tracheotomy (mini-surgical percutaneous dilatational tracheotomy) in at-risk situations including anatomical difficulties, coagulation disorders, hypoxemia, and hemodynamic instability, finding no difference in complications between techniques. 2
Specialized Population Trials
A large retrospective study of 125,000 tracheostomies demonstrated decreased rates of sepsis and ventilator-associated pneumonia with early timing. 5, 6
In traumatic brain injury patients specifically, a 2021 systematic review and meta-analysis in the Journal of Clinical Medicine included two RCTs, three observational trials, one cross-sectional study, and three retrospective cohort studies (total 5,106 patients), showing that early tracheostomy reduced VAP risk, ICU and hospital length of stay, and duration of mechanical ventilation, but paradoxically increased mortality risk. 7
Critical Interpretation
The major pitfall identified across trials is that 55% of patients randomized to late tracheostomy never required the procedure at all, highlighting the risk of performing unnecessary invasive procedures with early timing. 5 Trial sequential analysis indicates that additional trials are still needed for conclusive evidence across all outcomes. 4