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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05550220
Other study ID # modified CLT
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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