Jean-Louis Trouillet, MD; Charles-Edouard Luyt, MD, PhD; Marguerite Guiguet, PhD; Alexandre Ouattara, MD, PhD; Elisabeth Vaissier, MD; Ralouka Makri, MD; Ania Nieszkowska, MD; Pascal Leprince, MD, PhD; Alain Pavie, MD; Jean Chastre, MD; Alain Combes, MD, PhD
Trouillet J, Luyt C, Guiguet M, Ouattara A, Vaissier E, Makri R, et al. Early Percutaneous Tracheotomy Versus Prolonged Intubation of Mechanically Ventilated Patients After Cardiac Surgery: A Randomized Trial(A Randomized Trial*). Ann Intern Med. 2011;154:373-383. doi: 10.7326/0003-4819-154-6-201103150-00002
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Published: Ann Intern Med. 2011;154(6):373-383.
Whether early percutaneous tracheotomy in patients who require prolonged mechanical ventilation can shorten mechanical ventilation duration and lower mortality remains controversial.
To compare the outcomes of severely ill patients who require prolonged mechanical ventilation randomly assigned to early percutaneous tracheotomy or prolonged intubation.
Prospective, randomized, controlled, single-center trial (ClinicalTrials.gov registration number: NCT00347321).
216 adults requiring mechanical ventilation 4 or more days after cardiac surgery.
Immediate early percutaneous tracheotomy or prolonged intubation with tracheotomy 15 days after randomization.
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.
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.
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]).
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.
French Ministry of Health.
It is not clear whether early tracheotomy improves the outcome of patients who are expected to require prolonged mechanical ventilation.
In this randomized trial of patients who still required mechanical ventilation 4 days after cardiac surgery, immediate tracheotomy did not decrease mortality or length of intensive care unit or hospital stay or increase the number of days off the ventilator compared with waiting 2 weeks to consider tracheotomy. Early tracheotomy did, however, reduce the use of sedatives, ease nursing care, and improve patient comfort.
Patients in the control group were free of mechanical ventilation sooner than anticipated, possibly limiting the ability to detect a benefit from early tracheotomy.
More study is required to determine whether routine early tracheotomy is beneficial.
HRQoL = health-related quality of life; MV = mechanical ventilation; SAPS II = Simplified Acute Physiology Score.
Appendix Table 1.
No significant difference (log-rank test) was found between patients assigned to the EPT or PI group (hazard ratio, 1.01 [95% CI, 0.62 to 1.65]). EPT = early percutaneous tracheotomy; PI = prolonged intubation.
Appendix Table 2.
Appendix Table 3.
Appendix Table 4.
Patients assigned to early percutaneous tracheotomy received less midazolam (mean difference, −0.31 mg/kg/d [95% CI, −0.53 to −0.09 mg/kg/d]), propofol (mean difference, −2.87 mg/kg/d [CI, −4.76 to −0.98 mg/kg/d]), and sufentanil (mean difference, −0.48 µg/kg/d [CI, −0.77 to −0.19 µg/kg/d) than patients assigned to prolonged intubation. The bars indicate 95% CIs.
The early percutaneous tracheotomy group spent less time heavily sedated (P = 0.03) and more time calm, awake, or lightly sedated (P < 0.001) than the prolonged intubation group. The bars indicate 95% CIs.
Appendix Table 5.
The bars indicate 95% CIs. SF-36 = 36-Item Short Form Health Survey.
* P < 0.05 for early percutaneous tracheotomy and prolonged intubation vs. French population normative values.
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