A Modified Cuff Leak Test and Reintubation in Mechanically Ventilated Patients

Not Applicable

Completed

• Conditions: Airway Obstruction; Mechanical Ventilation Complication; Weaning Failure

• Registration Number: NCT05550220
• Lead Sponsor: Beijing Chao Yang Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2022-09-19
• Study First Submitted QC: 2022-09-21
• Study First Posted: 2022-09-22
• Study Start: 2022-11-01
• Status Verified: 2024-03
• Primary Completion: 2024-03-24
• Study Completion: 2024-03-24
• Last Update Submitted: 2024-03-24
• Last Update Posted: 2024-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 586

Inclusion Criteria

• Age ≥ 18 years old
• Oral endotracheal intubation and mechanical ventilation > 36 hours
• Fulfilled the weaning criteria

Exclusion Criteria

• The patient has a chest drainage tube and there is persistent air leak
• Abnormalities of the larynx: such as tumors or vocal cord paralysis
• The patient cannot maintain the semi-recumbent position
• Unconventional weaning, such as awake ECMO, etc
• Participated in the study during the hospitalization
• Patients or their relatives refused written informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
fulfilled predefined criteria indicating the need for reintubation within 48 hours following extubation	48 hours	The incidence of fulfilled predefined criteria indicating the need for reintubation within 48 hours following extubation

Secondary Outcome Measures

Name	Time	Method
length of hospital	90 days	the length of patient staying in hosptial
length of ICU	90 days	the length of patient staying in intensive care unit
Invasive mechanical ventilation time before first extubation	28 days	Invasive mechanical ventilation time before first extubation
Post-extubation stridor	24 hours	the occurrence of inspiratory stridor within 24 hours following tracheal extubation.
Reintubation within 48 hours after extubation	48 hours	The incidence of reintubation within 48 hours after extubation in the ICU.
required reintubation within 48 hours following extubation	48 hours	The incidence of required reintubation within 48 hours after extubation in the ICU.

Trial Locations

Locations (1)

Bing Sun; 🇨🇳 Beijing, Beijing, China