title: Early percutaneous tracheotomy versus prolonged intubation of mechanically ventilated patients after cardiac surgery: a randomized trial.
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.
  
  
  METHODS
  Prospective, randomized, controlled, single-center trial (ClinicalTrials.gov registration number: NCT00347321).
  
  
  METHODS
  Academic center.
  
  
  METHODS
  216 adults requiring mechanical ventilation 4 or more days after cardiac surgery.
  
  
  METHODS
  Immediate early percutaneous tracheotomy or prolonged intubation with tracheotomy 15 days after randomization.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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]).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  French Ministry of Health.
authors.affiliation: 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.
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Trouillet
authors.forename: Charles-Edouard
authors.initials: CE
authors.lastname: Luyt
authors.forename: Marguerite
authors.initials: M
authors.lastname: Guiguet
authors.forename: Alexandre
authors.initials: A
authors.lastname: Ouattara
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Vaissier
authors.forename: Ralouka
authors.initials: R
authors.lastname: Makri
authors.forename: Ania
authors.initials: A
authors.lastname: Nieszkowska
authors.forename: Pascal
authors.initials: P
authors.lastname: Leprince
authors.forename: Alain
authors.initials: A
authors.lastname: Pavie
authors.forename: Jean
authors.initials: J
authors.lastname: Chastre
authors.forename: Alain
authors.initials: A
authors.lastname: Combes
mesh_terms: D000328:Adult; D006348:Cardiac Surgical Procedures; D005260:Female; D006801:Humans; D007442:Intubation, Intratracheal / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D053208:Kaplan-Meier Estimate; D007902:Length of Stay; D008297:Male; D053717:Pneumonia, Ventilator-Associated / Q000209:etiology; D011446:Prospective Studies; D011788:Quality of Life; D012121:Respiration, Artificial / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D012680:Sensitivity and Specificity; D013997:Time Factors; D014140:Tracheotomy / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D016896:Treatment Outcome