Prediction of Extubation Failure: A Multicenter Prospective Observational Study

February 8, 2023 updated by: Duan jun, Chongqing Medical University

The First Affiliated Hospital of Chongqing Medical University

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

2604

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Chongqing, China
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The population is that the patients who passed a spontaneous breathing trial and readiness for extubation.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with extubation after a weaning trial
Patients who sucessfully complete a spontaneous breathing trial are enrolled in this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of extubation failure
Time Frame: From extubation to 48 hours
Extubation failure was defined as the reintubation or death
From extubation to 48 hours
Rate of extubation failure
Time Frame: From extubation to 7 days
Extubation failure was defined as the reintubation or death
From extubation to 7 days
Rate of extubation failure
Time Frame: From extubation to 28 days
Extubation failure was defined as the reintubation or death
From extubation to 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of mortality
Time Frame: From extubation to 28 days
Mortality in ICU and hospital
From extubation to 28 days
ICU stay
Time Frame: From extubation to 28 days
Length of ICU stay
From extubation to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chongqing Medical University

Investigators

  • Principal Investigator: Jun Duan, First Affiliated Hospital of Chongqing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 15, 2021

Primary Completion (ANTICIPATED)

December 31, 2024

Study Completion (ANTICIPATED)

December 31, 2024

Study Registration Dates

First Submitted

September 25, 2021

First Submitted That Met QC Criteria

September 25, 2021

First Posted (ACTUAL)

October 6, 2021

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 8, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ChongqingMU4

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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