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

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

Research Question: Does modified CLT approach have superior ability in predicting re-intubation compared with traditional method?

Study Design And Methods: This was a prospective, multicenter, randomized control trial. The primary end point was the incidence of the need for reintubation within 48 h after extubation. The secondary end points were the actual incidence of reintubation, the incidence of post-extubation stridor (PES), and the duration of invasive mechanical ventilation (IMV), etc. RESULT: There were totally 536 patients randomized to either modified CLT group (n = 268) or control group (n = 268). The incidence of reintubation within 48 h after extubation did not differ between the groups. PES within 24 h after 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 = 0.028). The IMV duration was shorter in the modified CLT group than in the control group (137 h [74, 218] vs. 159 h [95, 252]; OR 1.001 [95% CI, 1.000-1.002], P = 0.046). In the patients with IMV duration ≥6 days, the incidence of PES was 2.95% in modified CLT group and 0.74% in the control group (OR 0.203 [95% CI, 0.042-0.975], P = 0.048).

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

Clinicaltrials: GOV: NCT05550220, Registered 19 September 2022.