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.