Effect of Early vs Late Tracheostomy Placement on Survival in Patients Receiving Mechanical Ventilation: The TracMan Randomized Trial

Study Questions:

What is the impact of early versus late tracheostomy on mortality in adult patients requiring mechanical ventilation in critical care units?

Methods:

An open, multicenter, randomized clinical trial was conducted between 2004 and 2011, involving 70 adult general and two cardiothoracic critical care units in 13 university and 59 nonuniversity hospitals in the United Kingdom. Of 1,032 eligible patients, 909 adult patients breathing with the aid of mechanical ventilation for less than 4 days were identified by the treating physician as likely to require at least 7 more days of mechanical ventilation. Patients were randomized 1:1 to early tracheostomy (within 4 days) or late tracheostomy (after 10 days if still indicated). The primary outcome measure was 30-day mortality, and the analysis was by intention to treat.

Results:

Of the 455 patients assigned to early tracheostomy, 91.9% (95% confidence interval [CI], 89.0%-94.1%) received a tracheostomy, and of 454 assigned to late tracheostomy, 44.9% (95% CI, 40.4%-49.5%) received a tracheostomy. All-cause mortality 30 days after randomization was 30.8% (95% CI, 26.7%-35.2%) in the early and 31.5% (95% CI, 27.3%-35.9%) in the late group (absolute risk reduction for early vs. late, 0.7%; 95% CI, −5.4% to 6.7%). Two-year mortality was 51.0% (95% CI, 46.4%-55.6%) in the early and 53.7% (95% CI, 49.1%-58.3%) in the late group (p = 0.74). Median critical care unit length of stay in survivors was 13.0 days in the early and 13.1 days in the late group (p = 0.74). Tracheostomy-related complications were reported for 6.3% (95% CI, 4.6%-8.5%) of patients (5.5% in the early group, 7.8% in the late group).

Conclusions:

The authors concluded that for patients breathing with the aid of mechanical ventilation, tracheostomy within 4 days of critical care admission was not associated with an improvement in 30-day mortality or other important secondary outcomes.

Perspective:

This study suggests that early tracheostomy (within 4 days of admission) has no effect on mortality in mechanically ventilated patients identified by the treating clinician as likely to require at least an additional 7 days of ventilatory support compared with waiting 10 or more days before placing a tracheostomy if still indicated. Avoiding a significant proportion of tracheostomies, a procedure associated with a 6.3% acute complication rate in this study, did not appear to be associated with any significant increase in health care resource use, as measured by critical care unit or hospital stay. It would appear that delaying a tracheostomy until at least day 10 of a patient’s critical care unit stay is the best policy for now until tools to accurately predict the duration of mechanical ventilation on individual patients can be developed and validated.

Keywords: Survivors, Outcome Assessment (Health Care), Great Britain, Intensive Care Units, Tracheostomy, Respiration, Artificial, Cardiovascular Diseases, Dopamine


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