Mechanical VentilationNCT05069441
Prediction of Extubation Failure: A Multicenter Prospective Observational Study
An observational study of Mechanical Ventilation, run by Chongqing Medical University at 1 site in China.
Trial summary
The investigators intend to collect several variables to predict extubation failure among patients who successfully complete a spontaneous breathing trial, and then develop a scale using simple bedside indicators to predict extubation failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation
- How many people
- 2,604 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2021to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: The population is that the patients who passed a spontaneous breathing trial and readiness for extubation.
Who may be able to join
- Prepared for extubation through spontaneous breathing trial;Oral or nasal endotracheal intubation; be at least 18 years old
Who cannot join
- Extubation without a spontaneous breathing trial ;Reintubation due to secondary surgery; Tracheotomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing
Jun Duan, Dr, 89012017, duanjun412589@163.com
Linfu Bai, 89012680, 1023762525@qq.com
About this study
Official title: The First Affiliated Hospital of Chongqing Medical University
The investigators intend to collect several variables to predict extubation failure among patients who successfully complete a spontaneous breathing trial, and then develop a scale using simple bedside indicators to predict extubation failure.
Read the detailed description
Mechanically ventilated patients who successfully completed a spontaneous breathing trial and prepared for extubation are eligible to enroll in this study. The vital signs, arterial blood gas tests, cough strength, cuff leak test, use of noninvasive ventilation et al. are collected. Patients are followed up to postextubation 28-day or discharge. Extubation failure is defined as reintubatin or death within postextubation 7 days. First, we will analyze the data to predict extubation failure. Then, we will combine several easily obtained variables to develop and validate a scale to predict extubation failure. Finally, we explore the predictive power of extubation failure tested by the scale and find the cutoff value to distinguish the low, moderate and high risk of extubation failure.
- Conditions
- Mechanical Ventilation
- Keywords
- Extubation Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with extubation after a weaning trial | Patients who sucessfully complete a spontaneous breathing trial are enrolled in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of extubation failure
Extubation failure was defined as the reintubation or death
Measured: From extubation to 48 hours
Rate of extubation failure
Extubation failure was defined as the reintubation or death
Measured: From extubation to 7 days
Rate of extubation failure
Extubation failure was defined as the reintubation or death
Measured: From extubation to 28 days
Secondary outcomes (2)
Rate of mortality
Mortality in ICU and hospital
Measured: From extubation to 28 days
ICU stay
Length of ICU stay
Measured: From extubation to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start15 Oct 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,604 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duan jun, Chongqing Medical University
- Investigators
- Jun Duan, Principal investigator, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069441
- Sponsor's protocol ID
- ChongqingMU4
- Status last verified
- Mar 2026
- First submitted
- 25 Sep 2021
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The First Affiliated Hospital of Chongqing Medical University
- ClinicalTrials.gov ID
- NCT05069441
- Acronym / sponsor ID
- ChongqingMU4
- Conditions
- Mechanical Ventilation
- Keywords
- Extubation Failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,604 participants (estimated)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Oct 2021 (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.
The investigators intend to collect several variables to predict extubation failure among patients who successfully complete a spontaneous breathing trial, and then develop a scale using simple bedside indicators to predict extubation failure.
Detailed description
Mechanically ventilated patients who successfully completed a spontaneous breathing trial and prepared for extubation are eligible to enroll in this study. The vital signs, arterial blood gas tests, cough strength, cuff leak test, use of noninvasive ventilation et al. are collected. Patients are followed up to postextubation 28-day or discharge. Extubation failure is defined as reintubatin or death within postextubation 7 days. First, we will analyze the data to predict extubation failure. Then, we will combine several easily obtained variables to develop and validate a scale to predict extubation failure. Finally, we explore the predictive power of extubation failure tested by the scale and find the cutoff value to distinguish the low, moderate and high risk of extubation failure.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with extubation after a weaning trial | – | –Patients who sucessfully complete a spontaneous breathing trial are enrolled in this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population is that the patients who passed a spontaneous breathing trial and readiness for extubation.
Key inclusion criteria (1 listed)
- Prepared for extubation through spontaneous breathing trial;Oral or nasal endotracheal intubation; be at least 18 years old
Key exclusion criteria (1 listed)
- Extubation without a spontaneous breathing trial ;Reintubation due to secondary surgery; Tracheotomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of extubation failure
Time frame: From extubation to 48 hours
Extubation failure was defined as the reintubation or death
Rate of extubation failure
Time frame: From extubation to 7 days
Extubation failure was defined as the reintubation or death
Rate of extubation failure
Time frame: From extubation to 28 days
Extubation failure was defined as the reintubation or death
2 secondary outcomes
Rate of mortality
Time frame: From extubation to 28 days
ICU stay
Time frame: From extubation to 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
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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.
Jun Duan principal investigator
First Affiliated Hospital of Chongqing Medical University
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 Mechanical Ventilation, run by Chongqing 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: looking for participants now, as of the sponsor's last update on 23 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Duan, Dr (89012017, duanjun412589@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of extubation failure (time frame: From extubation to 48 hours). The study lists 3 primary outcomes in all. 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 23 Mar 2026.