NCT05550220|Completed
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Sponsor study identifier
interventional
586
1 country
1
Study Start
November 1, 2022
Actual (reported)Primary Completion
March 24, 2024
Actual (reported)Study Completion
March 24, 2024
Actual (reported)We hypothesized that the accuracy of the modified cuff leak test in predicting re-intubation in tracheal intubated patients is better than that of the conventional balloon leak test, thereby further reducing the re-intubation rate.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 24, 2024
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 19, 2022
Actual (reported)September 22, 2022
Actual (reported)November 1, 2022
Actual (reported)March 24, 2024
Actual (reported)March 24, 2024
Actual (reported)fulfilled predefined criteria indicating the need for reintubation within 48 hours following extubation
The incidence of fulfilled predefined criteria indicating the need for reintubation within 48 hours following extubation
48 hours
Reintubation within 48 hours after extubation
48 hours
Post-extubation stridor
24 hours
Invasive mechanical ventilation time before first extubation
28 days
length of ICU
90 days
length of hospital
90 days
mortality of 90 days
90 days
The subject was placed in a semi-recumbent position. The subjects were placed in volume assist-control mode with the following parameters: * respiratory rate 15 breaths/min * original oxygen concentration * PEEP 0 cm H2O * the VT was set according to the subject's stable VT in the previous ventilator mode * inspiratory flow was set at 30 L/min with square waveform Positive cutoff value of the air leak volume was 116 mL and the air leak ratio was 0.32.
The subjects were placed in volume assist-control mode with the following parameters: * respiratory rate was adapted to patient comfort * original oxygen concentration and PEEP * the VT about 8ml/Kg IBW * inspiratory flow was set at 60 L/min with square waveform Positive cutoff value of the air leak volume was 110 mL and the air leak ratio was 0.15.
Cuff leak test is a simple and convenient tool that can be used to predict upper-airway obstruction after extubation. The CLT is used to assess airway patency through listening for an air leak and observing changes in tidal volume (VT) after the cuff is deflated.
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Bing Sun
Beijing, Beijing Municipality, 100020, China
Tang X, Gu YM, Shi Y, Li ZM, Cao R, Lu SG, Wu YB, Tao YF, Sun ZY, Yin YJ, Liu CY, Tang XB, Gan GF, Qin XJ, Yin D, Zhao HB, Liu CY, Zhang L, Fang P, Du LS, Li L, Tan H, Li M, Zuo YT, Sun B; Chao-Yang Mechanical Ventilation Study Collaboration Group. Modified Cuff Leak Test for Predicting the Risk of Reintubation in Patients With Invasive Mechanical Ventilation: A Multicenter, Single-Anonymized, Randomized Controlled Trial. Chest. 2025 Jul;168(1):119-130. doi: 10.1016/j.chest.2025.01.033. Epub 2025 Feb 6.
586 participants (actual enrollment reported by the registry).
First Submitted
September 19, 2022
First Posted
September 22, 2022
Study Start
November 1, 2022
Actual (reported)Improving Our Understanding of Respiratory Muscle Training to Facilitate Weaning From Mechanical Ventilation in the ICU
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Primary Completion
March 24, 2024
Actual (reported)Study Completion
March 24, 2024
Actual (reported)Last Updated
March 26, 2024
Record last verified: 2024-03
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Source: ClinicalTrials.gov.
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