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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05069441
Other study ID # ChongqingMU4
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 15, 2021
Est. completion date December 31, 2024

Study information

Verified date February 2023
Source Chongqing Medical University
Contact Jun Duan, Dr
Phone 89012017
Email duanjun412589@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators intend to collect several variables to predict extubation failure among patients who successfully complete a spontaneous breathing trial, and then develop a scale using simple bedside indicators to predict extubation failure.


Description:

Mechanically ventilated patients who successfully completed a spontaneous breathing trial and prepared for extubation are eligible to enroll in this study. The vital signs, arterial blood gas tests, cough strength, cuff leak test, use of noninvasive ventilation et al. are collected. Patients are followed up to postextubation 28-day or discharge. Extubation failure is defined as reintubatin or death within postextubation 7 days. First, we will analyze the data to predict extubation failure. Then, we will combine several easily obtained variables to develop and validate a scale to predict extubation failure. Finally, we explore the predictive power of extubation failure tested by the scale and find the cutoff value to distinguish the low, moderate and high risk of extubation failure.


Recruitment information / eligibility

Status Recruiting
Enrollment 2604
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Prepared for extubation through spontaneous breathing trial;Oral or nasal endotracheal intubation; be at least 18 years old Exclusion Criteria: - Extubation without a spontaneous breathing trial ;Reintubation due to secondary surgery; Tracheotomy

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China The First Affiliated Hospital of Chongqing Medical University Chongqing

Sponsors (1)

Lead Sponsor Collaborator
Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of extubation failure Extubation failure was defined as the reintubation or death From extubation to 48 hours
Primary Rate of extubation failure Extubation failure was defined as the reintubation or death From extubation to 7 days
Primary Rate of extubation failure Extubation failure was defined as the reintubation or death From extubation to 28 days
Secondary Rate of mortality Mortality in ICU and hospital From extubation to 28 days
Secondary ICU stay Length of ICU stay From extubation to 28 days
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