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Early Percutaneous Tracheotomy Versus Prolonged Intubation of Mechanically Ventilated Patients After Cardiac Surgery: A Randomized Trial
Study Questions:
Does early tracheotomy shorten mechanical ventilation days or lower mortality in cardiac surgery patients who require prolonged mechanical ventilation?
Methods:
This was a prospective, randomized, controlled, single-center trial of immediate early percutaneous tracheotomy versus prolonged intubation with tracheotomy at 15 days post-randomization in adult cardiac surgery patients. The study was from June 2006 to March 2009 including all eligible post-cardiac surgery patients requiring mechanical ventilation 4 days post-surgery. In-hospital parameters included: ventilator-free days, sedation requirements, nurse-assessed comfort level, time to oral feeding and mobilization, and significant infections. Mortality was assessed at 28, 60, and 90 days. Long-term survivors were assessed >2 years post-randomization with health-related quality of life and psychosocial evaluations. An intention-to-treat analysis was performed (27% received tracheotomy in the prolonged ventilation group).
Results:
There was no difference in ventilator-free days during the first 60 days following randomization (mean, 30.4 vs. 28.3 days) nor in 28-, 60-, and 90-day mortality rates (16% vs. 21%, 26% vs. 28%, and 30% vs. 30%, respectively). There was no difference in ventilator-associated pneumonia, length of hospital stay, or duration of mechanical ventilation. Early percutaneous tracheotomy was associated with less sedation (less intravenous sedation, less time heavily sedated, and less use of haloperidol), fewer unscheduled extubations, better comfort and ease of care based on a nursing assessment, and earlier resumption of oral nutrition. Despite increased early mobilization in the early tracheotomy group, there was no difference in measured muscle strength score. At a mean follow-up of 873 days, there was no difference in survival, psychosocial evaluations, and health-related quality of life. No long-term survivor had problems with swallowing, phonation, or both in either group.
Conclusions:
Early tracheotomy for post-cardiac surgery patients with respiratory failure compared to prolonged ventilation with routine tracheotomy at 15 days has no benefit in terms ventilation, hospital morbidity, mortality, and long-term quality-of-life measures. It is associated with less sedation requirements, improved comfort, and earlier mobilization. The study is limited by the a priori power calculation that was not reflective of the population; however, the findings and implications of the study are still of significant importance.
Perspective:
The concern for sternal wound infections and mediastinitis often temper the enthusiasm for early tracheotomy in post-cardiac surgery patients. This study provides support that tracheotomy either on day 5 or day 15 does not impact ventilator days, length of hospitalization, mortality, or late quality-of-life measures. Although a difference in sternal infection rates was not detected, this lends support to allowing surgical wound healing prior to proceeding with tracheotomy for cardiac surgery patients with respiratory failure, as early tracheotomy has not been clearly shown in this or any other study to improve hospital outcomes for this population.
Keywords: Survivors, Pneumonia, Ventilator-Associated, Intubation, Follow-Up Studies, Respiration, Artificial, Tracheotomy, Respiratory Insufficiency, Cardiac Surgical Procedures, Hospitalization, Postoperative Period
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