Modified Cuff Leak Test for Predicting the Risk of Reintubation in Patients With Invasive Mechanical Ventilation: A Multicenter, Single-Anonymized, Randomized Controlled Trial

Abstract

Background: The cuff leak test (CLT) is an important tool to assess the risk of upper airway obstruction after extubation.

Research question: Does a modified CLT approach have superior ability in predicting reintubation compared with the traditional method?

Study design and methods: This was a prospective, multicenter, randomized controlled trial. The primary end point was the incidence of the need for reintubation within 48 hours of extubation. Secondary end points included, among others, the actual incidence of reintubation, the incidence of postextubation stridor (PES), and the duration of invasive mechanical ventilation (IMV).

Results: A total of 536 patients were randomized to either the modified CLT group (n = 268) or the control group (n = 268). The incidence of reintubation within 48 hours of extubation did not differ between the groups. PES within 24 hours of extubation was more frequent in the modified CLT group than in the control group (5.22% vs 1.49%; OR, 0.275 [95% CI, 0.089-0.846]; P = .028). The IMV duration was shorter in the modified CLT group than in the control group (137 hours [74, 218] vs 159 hours [95, 252]; OR, 1.001 [95% CI, 1.000-1.002]; P = .046). In the patients with IMV duration ≥ 6 days, the incidence of PES was 2.95% in the modified CLT group and 0.74% in the control group (OR, 0.203 [95% CI, 0.042-0.975]; P = .048).

Interpretation: Compared with the control group, the modified CLT approach might better predict PES within 24 hours of extubation, especially for patients with IMV duration longer than 6 days, but it was not shown to decrease the reintubation incidence and mortality.

Clinical trial registration: ClinicalTrials.gov; No.: NCT05550220; URL: clinicaltrials.gov.

Keywords: cuff leak test; invasive mechanical ventilation; postextubation stridor; reintubation.