• Jean-Louis Trouillet, Charles-Edouard Luyt, Marguerite Guiguet, Alexandre Ouattara, Elisabeth Vaissier, Ralouka Makri, Ania Nieszkowska, Pascal Leprince, Alain Pavie, Jean Chastre, and Alain Combes.
• 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.

BackgroundWhether early percutaneous tracheotomy in patients who require prolonged mechanical ventilation can shorten mechanical ventilation duration and lower mortality remains controversial.ObjectiveTo compare the outcomes of severely ill patients who require prolonged mechanical ventilation randomly assigned to early percutaneous tracheotomy or prolonged intubation.DesignProspective, randomized, controlled, single-center trial (ClinicalTrials.gov registration number: NCT00347321).SettingAcademic center.Patients216 adults requiring mechanical ventilation 4 or more days after cardiac surgery.InterventionImmediate early percutaneous tracheotomy or prolonged intubation with tracheotomy 15 days after randomization.MeasurementsThe 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.ResultsThere 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.LimitationThe prolonged intubation group had more ventilator-free days during days 1 to 60 than what was hypothesized (mean, 23.0 days [SD, 17.0]).ConclusionEarly 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 SourceFrench Ministry of Health.

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