Prediction of Extubation Failure: A Multicenter Prospective Observational Study

Mechanical Ventilation Clinical Trial

Official title:

The First Affiliated Hospital of Chongqing Medical University

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05069441
• Other study ID #: ChongqingMU4
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Mechanical Ventilation

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