NCT06424314

Brief Summary

This study is a prospective physiologic study. The primary study population will be adult invasive tracheal intubated patients with COPD, and investigators will collect relevant demographic data, vital signs, and baseline physiologic parameters of the patients prior to the spontaneous breathing test（SBT). The participants will be divided into a successful withdrawal group and a failed withdrawal group according to the SBT outcome, and the changes in the above parameters during SBT will be compared between the two groups .

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2024

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

First Submitted

Initial submission to the registry

May 16, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 22, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

July 9, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 9, 2024

Status Verified

July 1, 2024

Enrollment Period

12 months

First QC Date

May 16, 2024

Last Update Submit

July 8, 2024

Conditions

Weaning FailureCentral Respiratory DepressionDiaphragm InjuryPhrenic Nerve Disorder

Outcome Measures

Primary Outcomes (1)

  • weaning success

    passed SBT trial and weaning from mechanical ventilation success with no need of reintubation

    Day 2

Study Arms (2)

weaning success

Patient passed SBT test with no need to receive invasive mechanical ventilation 48 hours after extubation

Diagnostic Test: Monitoring of respiratory mechanics parameters

weaning failure

Patient failed SBT test or need to receive invasive mechanical ventilation 48 hours after extubation

Diagnostic Test: Monitoring of respiratory mechanics parameters

Interventions

Monitoring of respiratory mechanics parametersDIAGNOSTIC_TEST

Physiologic recording instrumentation measure maximal transdiaphragmatic pressure，twitch diaphragmatic pressure and maximal diaphragmatic electromyography

weaning failureweaning success

Eligibility Criteria

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

Patients undergoing weaning from mechanical ventilation；Hemodynamic stability

You may qualify if:

  • Invasive mechanical ventilation for at least 48 hours

You may not qualify if:

  • neuromuscular disease；Postoperative patients or patients with traumatic brain injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

RECRUITING

Central Study Contacts

Lili Guan, MD & PhD

CONTACT

020-81566675dr_nickguan@163.com

Qiaoyun Huang

CONTACT

020-81566675huangqiaoyun23@foxmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 16, 2024

First Posted

May 22, 2024

Study Start

July 9, 2024

Primary Completion

July 1, 2025

Study Completion

December 1, 2025

Last Updated

July 9, 2024

Record last verified: 2024-07

Locations

CN(1)