Exploration of Mechanisms for Weaning Failure

Recruiting

• Conditions: Diaphragm Injury; Phrenic Nerve Disorder; Weaning Failure; Central Respiratory Depression
• Interventions: Diagnostic Test: Monitoring of respiratory mechanics parameters

• Registration Number: NCT06424314
• Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University

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 .

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 Timeline

• Study First Submitted: 2024-05-16
• Study First Submitted QC: 2024-05-16
• Study First Posted: 2024-05-22
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-08
• Study Start: 2024-07-09
• Last Update Posted: 2024-07-09
• Primary Completion: 2025-07-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Invasive mechanical ventilation for at least 48 hours

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
weaning failure	Monitoring of respiratory mechanics parameters	Patient failed SBT test or need to receive invasive mechanical ventilation 48 hours after extubation
weaning success	Monitoring of respiratory mechanics parameters	Patient passed SBT test with no need to receive invasive mechanical ventilation 48 hours after extubation

Primary Outcome Measures

Name	Time	Method
weaning success	Day 2	passed SBT trial and weaning from mechanical ventilation success with no need of reintubation

Trial Locations

Locations (1)

The First Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China