Prediction of Extubation Failure: A Multicenter Prospective Observational Study

Recruiting

• Conditions: Mechanical Ventilation

• Registration Number: NCT05069441
• Lead Sponsor: Chongqing Medical University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-09-25
• Study First Submitted QC: 2021-09-25
• Study First Posted: 2021-10-06
• Study Start: 2021-10-15
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-08
• Last Update Posted: 2023-02-09
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2604

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of extubation failure	From extubation to 28 days	Extubation failure was defined as the reintubation or death

Secondary Outcome Measures

Name	Time	Method
Rate of mortality	From extubation to 28 days	Mortality in ICU and hospital
ICU stay	From extubation to 28 days	Length of ICU stay

Trial Locations

Locations (1)

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, China