Traqueostomía percutánea temprana versus intubación mecánica prolongada en pacientes con ventilación mecánica después de cirugía cardiaca: estudio randomizado

Traqueostomía percutánea temprana versus intubación mecánica prolongada en pacientes con ventilación mecánica después de cirugía cardiaca: estudio randomizado

Early percutaneous tracheotomy versus prolonged intubation of mechanically ventilated patients after cardiac surgery: a randomized trial. Trouillet JL, Luyt CE, Guiguet M, Ouattara A, Vaissier E, Makri R, Nieszkowska A, Leprince P, Pavie A, Chastre J, Combes A. Institut de Cardiologie, Hôpital de la Pitié-Salpêtriére, Assistance Publique-Hôpitaux de Paris, Université Pierre et Marie Curie, Institut National de la Santé et de la Recherche Médicale, Paris, France. Ann Intern Med. 2011 Mar 15;154(6):373-83. Abstract Background: Whether early percutaneous tracheotomy in patients who require prolonged mechanical ventilation can shorten mechanical ventilation duration and lower mortality remains controversial. Objective: To compare the outcomes of severely ill patients who require prolonged mechanical ventilation randomly assigned to early percutaneous tracheotomy or prolonged intubation. Design: Prospective, randomized, controlled, single-center trial (ClinicalTrials.gov registration number: NCT00347321). Setting: Academic center. Patients: 216 adults requiring mechanical ventilation 4 or more days after cardiac surgery. Intervention: Immediate early percutaneous tracheotomy or prolonged intubation with tracheotomy 15 days after randomization. Measurements: The primary end point was the number of ventilator-free days during the first 60 days after randomization. Secondary outcomes included 28-, 60-, or 90-day mortality rates; durations of mechanical ventilation, intensive care unit stay, and hospitalization; sedative, analgesic, and neuroleptic use; ventilator-associated pneumonia rate; unscheduled extubations; comfort and ease of care; and long-term health-related quality of life (HRQoL) and psychosocial evaluations. Results: There was no difference in ventilator-free days during the first 60 days after randomization between early percutaneous tracheotomy and prolonged intubation groups (mean, 30.4 days [SD, 22.4] vs. 28.3 days [SD, 23.7], respectively; absolute difference, 2.1 days [95% CI, -4.1 to 8.3 days]) nor in 28-, 60-, or 90-day mortality rates (16% vs. 21%, 26% vs. 28%, and 30% vs. 30%, respectively). The durations of mechanical ventilation and hospitalization, as well as frequencies of ventilator-associated pneumonia and other severe infections, were also similar. However, early percutaneous tracheotomy was associated with less intravenous sedation; less time of heavy sedation; less haloperidol use for agitation, delirium, or both; fewer unscheduled extubations; better comfort and ease of care; and earlier resumption of oral nutrition. After a median follow-up of 873 days, between-group survival, psychosocial evaluations, and HRQoL were similar. Limitation: The prolonged intubation group had more ventilator-free days during days 1 to 60 than what was hypothesized (mean, 23.0 days [SD, 17.0]). Conclusion: Early tracheotomy provided no benefit in terms of mechanical ventilation and length of hospital stay, rates of mortality or infectious complications, and long-term HRQoL for patients who require prolonged mechanical ventilation after cardiac surgery. However, the well-tolerated procedure was associated with less sedation, better comfort, and earlier resumption of autonomy. Primary Funding Source: French Ministry of Health http://www.annals.org/content/154/6/373.full.pdf+html