COMPARATIVE CLINICAL-TRIAL OF STANDARD OPERATIVE TRACHEOSTOMY WITH PERCUTANEOUS TRACHEOSTOMY

Objective: To compare percutaneous tracheostomy with conventional operative tracheostomy. Design: Randomized clinical trial. Setting: The medical and surgical critical care units of a large, tertiary-care, private hospital. Patients: Twenty-five male and 21 female translaryngeally intubated patients with respiratory failure, in whom tracheostomy was indicated on clinical grounds, were randomly assigned to one of two groups. Interventions: The 24 patients in group 1 underwent conventional operative tracheostomy, and the 22 patients in group 2 underwent percutaneous tracheostomy. One patient in group 2 required tracheostomy on three separate occasions during a prolonged hospital stay. Measurements and Main Results: Patients were examined daily throughout their hospital stays for adverse events related to the tracheostomy. In all patients who survived until decannulation, plain tomography of the trachea was performed within 3 days of decannulation. Repeat physical and tomographic examinations were performed 6 and 12 wks later. Fifty-eight percent (14/24) of the operative tracheostomies were associated with at least one complication, compared with 25% (6/24) of the percutaneous tracheostomies (p < .05, 95% confidence interval 7% to 59%). Pre-decannulation problems were more frequent in group 1 patients than in group 2 (46% vs. 13%, respectively; p < .01, 95% confidence interval 9% to 57%), as were later sequelae (88% vs. 27%; p < .05, confidence interval 26% to 96%) in survivors. Group 1 patients were more likely to have multiple complications, and their complications tended to be more serious. Conclusion: In this study, percutaneous tracheostomy appeared to be superior to the conventional operation.