Exploration of Mechanisms for Weaning Failure

June 3, 2024 updated by: Guan Lili, The First Affiliated Hospital of Guangzhou Medical University

Changes in Respiratory Mechanics in Patients With Failed Ventilator Withdrawal

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 .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This observational study mainly include participants who had invasive mechanical ventilation for ≥48 h and are assessed to be ready for the SBT trial.The SBT approach is based on the low-level pressure support mode.

Prior to the SBT trial, baseline demographic and physiologic data of the participants will be collected, and the participants will be divided into two groups based on the results of the SBT trial: successful and unsuccessful, and the physiologic changes during the SBT trial will be compared between the two groups, respectively.

Study Type

Observational

Enrollment (Estimated)

30

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 Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing weaning from mechanical ventilation；Hemodynamic stability

Description

Inclusion Criteria:

  • Invasive mechanical ventilation for at least 48 hours

Exclusion Criteria:

  • neuromuscular disease； not first attempt at SBT for weaning

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
Intervention / Treatment
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
Physiologic recording instrumentation measure maximal transdiaphragmatic pressure，twitch diaphragmatic pressure and maximal diaphragmatic electromyography
weaning failure
Patient failed SBT test or need to receive invasive mechanical ventilation 48 hours after extubation
Diagnostic test: Monitoring of respiratory mechanics parameters
Physiologic recording instrumentation measure maximal transdiaphragmatic pressure，twitch diaphragmatic pressure and maximal diaphragmatic electromyography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weaning success
Time Frame: Day 2
passed SBT trial and weaning from mechanical ventilation success with no need of reintubation
Day 2

Collaborators and Investigators

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

Sponsor

The First Affiliated Hospital of Guangzhou 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 (Estimated)

June 15, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

May 16, 2024

First Submitted That Met QC Criteria

May 16, 2024

First Posted (Actual)

May 22, 2024

Study Record Updates

Last Update Posted (Estimated)

June 4, 2024

Last Update Submitted That Met QC Criteria

June 3, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202220252311

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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