NCT05069441

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,604

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Oct 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
Oct 2021Dec 2026

First Submitted

Initial submission to the registry

September 25, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 6, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

October 15, 2021

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

5.2 years

First QC Date

September 25, 2021

Last Update Submit

March 20, 2026

Conditions

Mechanical Ventilation

Keywords

Extubation Failure

Outcome Measures

Primary Outcomes (3)

  • 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 (2)

  • Rate of mortality

    From extubation to 28 days

  • ICU stay

    From extubation to 28 days

Study Arms (1)

Patients with extubation after a weaning trial

Patients who sucessfully complete a spontaneous breathing trial are enrolled in this group.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Prepared for extubation through spontaneous breathing trial;Oral or nasal endotracheal intubation; be at least 18 years old

You may not qualify if:

  • Extubation without a spontaneous breathing trial ;Reintubation due to secondary surgery; Tracheotomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

RECRUITING

Study Officials

  • Jun Duan

    First Affiliated Hospital of Chongqing Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Duan, Dr

CONTACT

89012017duanjun412589@163.com

Linfu Bai, Dr

CONTACT

890126801023762525@qq.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 25, 2021

First Posted

October 6, 2021

Study Start

October 15, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 23, 2026

Record last verified: 2026-03

Locations

CN(1)