Fiberoptic Bronchoscopy Monitoring During Percutaneous Dilatational Tracheostomy: A Multicenter, Randomized, Controlled Trial. The FIBERTRACH Randomized Clinical Trial

OBJECTIVES: To assess the prevalence of perioperative complications of endoscopic-guided percutaneous dilatational tracheostomy vs. nonendoscopic-guided percutaneous dilatational tracheostomy. DESIGN: Multicenter, unblinded, randomized parallel-group trial with an intention-to-treat analysis conducted from December 2019 to December 2024. ClinicalTrials.gov Identifier: NCT04265625. SETTING: Four medical-surgical ICUs in Spain. PATIENTS: Adults undergoing tracheostomy for prolonged mechanical ventilation were enrolled. INTERVENTIONS: Patients were randomized to: 1) endoscopic-guided percutaneous dilatational tracheostomy or 2) nonendoscopic-guided percutaneous dilatational tracheostomy, both performed with the single dilatation method and by experienced clinicians in patients with no risk factors. MEASUREMENTS AND MAIN RESULTS: The primary endpoint was the prevalence of perioperative complications. The secondary endpoints included airway pressures during the procedure, gas exchange after the procedure and all-cause mortality at hospital discharge. We enrolled 442 patients, 221 patients assigned to each arm. Twenty-five patients (11.3%) in the endoscopic-guided percutaneous dilatational tracheostomy group and 29 (13.1%) in nonendoscopic-guided percutaneous dilatational tracheostomy group had perioperative complications (95% CI, -6.8 to 10.4; p = 0.663). Patients randomized to endoscopic-guided percutaneous dilatational tracheostomy had higher mean peak inspiratory pressure (47.4 ± 17.6 vs. 37.05 ± 10.6 cm H 2 O; 95% CI, 7.5-13.2; p < 0.001) during the procedure and higher mean Pa co2 at the end of the procedure (44.3 ± 8.9 vs. 41.5 ± 8.1 mm Hg; 95% CI, 1.1-4.4; p = 0.001) than nonendoscopic-guided percutaneous dilatational tracheostomy patients. CONCLUSIONS: In critically ill patients undergoing percutaneous dilatational tracheostomy, the routine use of endoscopic guidance did not demonstrate superiority over procedures performed without endoscopic guidance in terms of complication rates.