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RecruitingNCT06424314Updated Jul 9, 2024

Exploration of Mechanisms for Weaning Failure

An observational study in Weaning Failure, Central Respiratory Depression and Diaphragm Injury, sponsored by The First Affiliated Hospital of Guangzhou Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-09.

Sponsored by The First Affiliated Hospital of Guangzhou Medical University · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started Jul 2024; still recruiting 2 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study 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 .

Read the 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.

02

Conditions studied

  • Weaning Failure
  • Central Respiratory Depression
  • Diaphragm Injury
  • Phrenic Nerve Disorder
03

In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's planned enrollment of 30 is below the median of 100 across 545 observational studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University is the lead sponsor of 158 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients undergoing weaning from mechanical ventilation;Hemodynamic stability

Inclusion criteria

  • Invasive mechanical ventilation for at least 48 hours

Exclusion criteria

Exclusion Criteria:

  • neuromuscular disease;Postoperative patients or patients with traumatic brain injury
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testMonitoring of respiratory mechanics parameters

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

06

What researchers measure

Primary outcomes

  1. weaning success

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

    Time frame: Day 2

07

Study locations

1 of 1 sites recruiting
  • The First Hospital of Guangzhou Medical University
    Guangzhou, Guangdong, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06424314
Lead sponsor
The First Affiliated Hospital of Guangzhou Medical University
Responsible party
Guan Lili (MD, The First Affiliated Hospital of Guangzhou Medical University) — Principal investigator
First posted
May 22, 2024
Start date
Jul 9, 2024
Primary completion
Jul 1, 2025 (estimated)
Completion
Dec 1, 2025 (estimated)
Last update
Jul 9, 2024

Study contacts

Lili Guan, MD & PhD
Contact
dr_nickguan@163.com
020-81566675
Qiaoyun Huang
Contact
huangqiaoyun23@foxmail.com
020-81566675

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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