OBJECTIVE: To compare the safety, availability, and long-term sequelae of percutaneous vs. surgical tracheostomy. DESIGN: Prospective, randomized, controlled study. SETTING: Combined medical/surgical intensive care unit in a tertiary referral hospital. PATIENTS: Two hundred critically ill mechanically ventilated patients who required tracheostomy. INTERVENTIONS: Tracheostomy by either percutaneous tracheostomy or surgical tracheostomy performed in the intensive care unit. MEASUREMENTS AND MAIN RESULTS: The primary outcome measure was the aggregate incidence of predefined moderate or severe complications. The secondary outcome measures were the incidence of each of the components of the primary outcome. Long-term follow-up included clinical assessment, flow volume loops, and bronchoscopy. Both groups were well matched for age, gender, admission Acute Physiology and Chronic Health Evaluation II score, period of endotracheal intubation, reason for intubation, and admission diagnosis. There was no statistical difference between groups for the primary outcome. Bleeding requiring surgical intervention occurred in three percutaneous tracheostomy patients and in no surgical tracheostomy patient (p = .2). Postoperative infection (p = .044) and cosmetic sequelae (p = .08) were more common in surgical tracheostomy patients. There was a shorter delay from randomization to percutaneous tracheostomy vs. surgical tracheostomy (p = .006). Long-term follow-up revealed no complications in either group. CONCLUSIONS: Both percutaneous tracheostomies and surgical tracheostomies can be safely performed at the bedside by experienced, skilled practitioners.
RCT Entities:
OBJECTIVE: To compare the safety, availability, and long-term sequelae of percutaneous vs. surgical tracheostomy. DESIGN: Prospective, randomized, controlled study. SETTING: Combined medical/surgical intensive care unit in a tertiary referral hospital. PATIENTS: Two hundred critically ill mechanically ventilated patients who required tracheostomy. INTERVENTIONS: Tracheostomy by either percutaneous tracheostomy or surgical tracheostomy performed in the intensive care unit. MEASUREMENTS AND MAIN RESULTS: The primary outcome measure was the aggregate incidence of predefined moderate or severe complications. The secondary outcome measures were the incidence of each of the components of the primary outcome. Long-term follow-up included clinical assessment, flow volume loops, and bronchoscopy. Both groups were well matched for age, gender, admission Acute Physiology and Chronic Health Evaluation II score, period of endotracheal intubation, reason for intubation, and admission diagnosis. There was no statistical difference between groups for the primary outcome. Bleeding requiring surgical intervention occurred in three percutaneous tracheostomy patients and in no surgical tracheostomy patient (p = .2). Postoperative infection (p = .044) and cosmetic sequelae (p = .08) were more common in surgical tracheostomy patients. There was a shorter delay from randomization to percutaneous tracheostomy vs. surgical tracheostomy (p = .006). Long-term follow-up revealed no complications in either group. CONCLUSIONS: Both percutaneous tracheostomies and surgical tracheostomies can be safely performed at the bedside by experienced, skilled practitioners.
Authors: David B Seder; Kiwon Lee; Celine Rahman; Nirmala Rossan-Raghunath; Luis Fernandez; Fred Rincon; Jan Claassen; Errol Gordon; Stephan A Mayer; Neeraj Badjatia Journal: Neurocrit Care Date: 2009-01-06 Impact factor: 3.210