Akiva Nachshon, Avishai W. Shapiro, Smadar Goldfarb, Natalia Kuzmina, Marc Romain, Asaf Schwartz, Avraham Abutbul, Ido Vilchik, Michael Beil, Peter Vernon van Heerden, the Tracheostomy Study Group, Sigal Sviri, Shimon Firman, Galel Yakobi, Abed Abubaih, Tamer A. Jreis, Bana Obeid, Dana A. Hamdan, Mahmoud Dabash, Mohammad Shehadeh, Stéphane Ledot, Tamar Stivi, Baruch Batzofin
BACKGROUND: Bronchoscopic guidance is commonly used during percutaneous dilational tracheostomy (PCT) despite limited and conflicting evidence; this study aimed to evaluate whether bronchoscopy improves the safety of PCT in mechanically ventilated patients. METHODS: This prospective, randomized controlled study compared two approaches of percutaneous tracheostomy; with and without bronchoscopy assistance. The primary outcome measured was a composite of procedure-related complications at 24 hours, classified as minor (e.g., bleeding, desaturation) or major (e.g., airway loss, tracheal rupture, severe pneumothorax, major bleeding requiring transfusion and death). Secondary outcomes included procedure duration, 30-day mortality, and hospital length of stay. INTERVENTIONS: PCT performed with or without bronchoscopic guidance. RESULTS: 307 adults requiring PCT between 2016 and 2024 were randomized to PCT with bronchoscopy (n=154) or without (n=153). Minor complications, particularly intra - procedural hypertension, were more frequent in the bronchoscopy group versus the non bronchoscopy (37.6% vs. 22.7% respectively p = 0.005). No significant differences were found in 24-hour mortality (1% for both), 30-day mortality (24.8% vs. 26.6%; p = 0.72), or hospital length of stay (40.5 ± 48.7 days vs. 38.9 ± 33.1 days; p = 0.73). Mean procedure duration was longer with bronchoscopy (5.46 vs. 4.17 minutes; p = 0.003). Major complication rates were identical (5.2% p = 0.8). CONCLUSIONS: Bronchoscopy during PCT does not reduce major complications or mortality, but increases procedure time, complexity, and costs. For experienced proceduralists, PCT without bronchoscopy is safe and may represent a more efficient approach. Multicenter studies are needed to assess generalizability of these findings. TRIAL REGISTRATION: This study was registered at ClinicalTrials.gov (identifier: NCT02802527) on April 13 2016.