Weaning FailureNCT06424314
Exploration of Mechanisms for Weaning Failure
An observational study of Weaning Failure and Central Respiratory Depression, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Weaning Failure, Central Respiratory Depression, Diaphragm Injury
- What is being tested?
- Monitoring of respiratory mechanics parameters
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 9 Jul 2024to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing weaning from mechanical ventilation；Hemodynamic stability
Who may be able to join
- Invasive mechanical ventilation for at least 48 hours
Who cannot join
- neuromuscular disease；Postoperative patients or patients with traumatic brain injury
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Lili Guan, MD & PhD, 020-81566675, dr_nickguan@163.com
Qiaoyun Huang, 020-81566675, huangqiaoyun23@foxmail.com
About this study
Official title: 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 .
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.
- Being tested
- Monitoring of respiratory mechanics parameters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring of respiratory mechanics parametersDiagnostic test
Physiologic recording instrumentation measure maximal transdiaphragmatic pressure，twitch diaphragmatic pressure and maximal diaphragmatic electromyography
| Study group | Role | What they receive |
|---|---|---|
| weaning success | Patient passed SBT test with no need to receive invasive mechanical ventilation 48 hours after extubation Receives: Diagnostic Test: Monitoring of respiratory mechanics parameters | |
| weaning failure | Patient failed SBT test or need to receive invasive mechanical ventilation 48 hours after extubation Receives: Diagnostic Test: Monitoring of respiratory mechanics parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
weaning success
passed SBT trial and weaning from mechanical ventilation success with no need of reintubation
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start9 Jul 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weaning FailureStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guan Lili, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424314
- Sponsor's protocol ID
- 202220252311
- Status last verified
- Jul 2024
- First submitted
- 16 May 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Respiratory Mechanics in Patients With Failed Ventilator Withdrawal
- ClinicalTrials.gov ID
- NCT06424314
- Acronym / sponsor ID
- 202220252311
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 9 Jul 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 22 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| weaning success | – | Diagnostic Test: Monitoring of respiratory mechanics parametersPatient passed SBT test with no need to receive invasive mechanical ventilation 48 hours after extubation |
| weaning failure | – | Diagnostic Test: Monitoring of respiratory mechanics parametersPatient failed SBT test or need to receive invasive mechanical ventilation 48 hours after extubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing weaning from mechanical ventilation；Hemodynamic stability
Key inclusion criteria (1 listed)
- Invasive mechanical ventilation for at least 48 hours
Key exclusion criteria (1 listed)
- neuromuscular disease；Postoperative patients or patients with traumatic brain injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring of respiratory mechanics parametersPhysiologic recording instrumentation measure maximal transdiaphragmatic pressure，twitch diaphragmatic pressure and maximal diaphragmatic electromyography | Diagnostic test | weaning failure, weaning success |
Primary outcome
weaning success
Time frame: Day 2
passed SBT trial and weaning from mechanical ventilation success with no need of reintubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weaning Failure and Central Respiratory Depression, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lili Guan, MD & PhD (020-81566675, dr_nickguan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weaning success (time frame: Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.