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NCT06424314 Clinical Trial

Exploration of Mechanisms for Weaning Failure

Weaning Failure Clinical Trial

Official title:
Changes in Respiratory Mechanics in Patients With Failed Ventilator Withdrawal

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06424314
Other study ID # 202220252311
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 15, 2024
Est. completion date December 1, 2025

Study information
Verified date June 2024
Source The First Affiliated Hospital of Guangzhou Medical University
Contact Lili Guan, MD & PhD
Phone 020-81566675
Email dr_nickguan@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 .

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 30
Est. completion date December 1, 2025
Est. primary completion date July 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Invasive mechanical ventilation for at least 48 hours Exclusion Criteria: - neuromuscular disease; not first attempt at SBT for weaning

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Monitoring of respiratory mechanics parameters
Physiologic recording instrumentation measure maximal transdiaphragmatic pressure,twitch diaphragmatic pressure and maximal diaphragmatic electromyography

Locations
Country Name City State
China The First Hospital of Guangzhou Medical University Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary weaning success passed SBT trial and weaning from mechanical ventilation success with no need of reintubation Day 2
See also
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