A multicenter randomized controlled trial conducted in four medical-surgical ICUs in Spain evaluated whether endoscopic guidance during percutaneous dilatational tracheostomy reduces perioperative complications in adults with prolonged mechanical ventilation. A total of 442 patients were randomized to undergo either endoscopic-guided or nonendoscopic-guided tracheostomy.
The primary outcome, prevalence of perioperative complications, occurred in 11.3% of the endoscopic group versus 13.1% of the nonendoscopic group, a difference that was not statistically significant (95% CI, -6.8 to 10.4; p = 0.663). However, secondary outcomes revealed that the endoscopic group had significantly higher mean peak inspiratory pressure during the procedure (47.4 vs 37.05 cm H2O; p < 0.001) and higher mean PaCO2 at the end of the procedure (44.3 vs 41.5 mm Hg; p = 0.001).
The study was unblinded, which may introduce bias. No limitations were reported, and funding or conflicts were not disclosed. The results suggest that routine use of endoscopic guidance does not offer advantages in reducing complications and may be associated with adverse physiological changes during the procedure.
Clinicians should weigh these findings when deciding on the use of endoscopic guidance for percutaneous tracheostomy. The lack of benefit in complication rates, combined with increased airway pressures and hypercapnia, suggests that nonendoscopic guidance may be a reasonable alternative.
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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.