Prediction of Extubation Failure: A Multicenter Prospecti... | NCT05069441

Studies
Prediction of Extubation Failure: A Multicenter Prospective Observational Study

NCT05069441

Sponsor

Chongqing Medical University

Status

Recruiting

Last Update Posted

Mar 23, 2026Actual

Enrollment

2,604Estimated

Phase

Not provided

Conditions

Mechanical Ventilation

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2021Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Sep 25, 2021

First Submission Date that Met QC Criteria

Sep 25, 2021

First Posted Date

Oct 6, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2026

Last Update Posted Date

Mar 23, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,604Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with extubation after a weaning trial		Patients who sucessfully complete a spontaneous breathing trial are enrolled in this group.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jun Duan, Dr	Contact	89012017		duanjun412589@163.com
Linfu Bai, Dr	Contact	89012680		1023762525@qq.com

Overall Officials

Name	Affiliation	Role
Jun Duan	First Affiliated Hospital of Chongqing Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of Chongqing Medical University	Recruiting	Chongqing			China