A Modified Cuff Leak Test and Reintubation in Mechanically Ventilated Patients

Mechanical Ventilation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05550220
• Other study ID #: modified CLT
• Status: Completed
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: March 24, 2024

Study information

• Verified date: March 2024
• Source: Beijing Chao Yang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 586
• Est. completion date: March 24, 2024
• Est. primary completion date: March 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Airway Obstruction
• Mechanical Ventilation Complication
• Weaning Failure

Intervention

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.

Locations

Country	Name	City	State
China	Bing Sun	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	mortality of 90 days	mortality of 90 days	90 days
Primary	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
Secondary	Reintubation within 48 hours after extubation	The incidence of reintubation within 48 hours after extubation in the ICU.	48 hours
Secondary	Post-extubation stridor	the occurrence of inspiratory stridor within 24 hours following tracheal extubation.	24 hours
Secondary	Invasive mechanical ventilation time before first extubation	Invasive mechanical ventilation time before first extubation	28 days
Secondary	length of ICU	the length of patient staying in intensive care unit	90 days
Secondary	length of hospital	the length of patient staying in hosptial	90 days
Secondary	required reintubation within 48 hours following extubation	The incidence of required reintubation within 48 hours after extubation in the ICU.	48 hours