NCT05550220

A Modified Cuff Leak Test and Reintubation in Mechanically Ventilated Patients

A Modified Cuff Leak Test and Reintubation in Mechanically Ventilated Patients: a Multicenter Randomised Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 586 (actual)
• Sponsor: Beijing Chao Yang Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The cuff leak test is an effective method for predicting the occurrence of upper airway obstruction in patients with endotracheal intubation after extubation, with high specificity and moderate sensitivity. However, there is still no clear and unified cuff leak test operation specification. A cohort study has proposed a modified method. When the patient is placed in a semi-recumbent position of 60 degrees and the ventilator is set to a low-flow square wave, it is more predictive than conventional methods. 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.

Conditions

• Mechanical Ventilation Complication
• Weaning Failure
• Airway Obstruction

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Cuff Leak Test	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.

Timeline

• Start date: 2022-11-01
• Primary completion: 2024-03-24
• Completion: 2024-03-24
• First posted: 2022-09-22
• Last updated: 2024-03-26

Locations

1 site across 1 country: China