Ventilator WeaningNCT02921334
Early Tracheotomy for Switching Between Invasive and Noninvasive Ventilation to Facilitate Weaning
A study testing switching between invasive and noninvasive ventilation in people with Ventilator Weaning, run by Chongqing Medical University at 1 site in China.
Trial summary
The aim of this study is early tracheotomy to facilitate weaning by switching between invasive and noninvasive ventilation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ventilator Weaning
- What is being tested?
- switching between invasive and noninvasive ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to 30 Dec 2019
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- duration of invasive ventilation 5 to 7 days
- anticipation of difficult weaning
- Glasgow Coma Scale ≥13
- no upper airway obstruction
- presence of spontaneous breath
Who cannot join
- age less than 18 or more than 85 years;
- contraindications for noninvasive ventilation;
- anticipation of survival less than 6 months;
- refusal of tracheotomy
Trial locations and contacts
1 site in 1 country.
China1 site
The first affiated hospital, chongqing medical university
Chongqing, Chongqing Municipality, 400016
About this study
Official title: Efficacy and Safety of Early Tracheotomy for Switching Between Invasive and Noninvasive Ventilation to Facilitate Weaning: a Randomized Control Trial
The aim of this study is early tracheotomy to facilitate weaning by switching between invasive and noninvasive ventilation.
Read the detailed description
When a patient is eligible to this study, he or she is randomly assigned to intervention or control group.In intervention group,tracheotomy is performed. And then, patient is switched to noninvasive ventilation by masking the tracheotomy tube. If the patient presents distress in noninvasive ventilation, he or she is switched to invasive ventilation. If the distress relieves, patient is switched to noninvasive ventilation again until the patient successfully weans from ventilator. In control group, the patient is weaned as the conventional methods.
- Conditions
- Ventilator Weaning
- Being tested
- switching between invasive and noninvasive ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
switching between invasive and noninvasive ventilationProcedure or surgery
As defined criteria, patients are switched between invasive and noninvasive ventilation until the ventilator is successfully weaned.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Patients in this group are received ventilator weaning by switching between invasive and noninvasive ventilation. Receives: Procedure: switching between invasive and noninvasive ventilation |
| Control group | No intervention | Patients in this group are weaned from ventilator as conventional methods. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ventilator weaning days
Measured: from enrollment to 90 days
Secondary outcomes (5)
successful weaning rate
Measured: from enrollment to 90 days
ICU stay days
Measured: from admission to 90 days
hospital stay days
Measured: from admission to 90 days
ICU mortality
Measured: from admission to 90 days
hospital mortality
Measured: from admission to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study startSep 2016
- Primary completion30 Sep 2019
- Study completion30 Dec 2019
Why it stopped: Difficult patient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator WeaningStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 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
- Shuliang Guo, MD, Principal investigator, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921334
- Sponsor's protocol ID
- cqykdxfsdyyy3
- Status last verified
- Mar 2026
- First submitted
- 28 Sep 2016
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Early Tracheotomy for Switching Between Invasive and Noninvasive Ventilation to Facilitate Weaning: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02921334
- Acronym / sponsor ID
- cqykdxfsdyyy3
- Conditions
- Ventilator Weaning
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficult patient enrollment
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 3 Oct 2016 (estimated)
- 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 aim of this study is early tracheotomy to facilitate weaning by switching between invasive and noninvasive ventilation.
Detailed description
When a patient is eligible to this study, he or she is randomly assigned to intervention or control group.In intervention group,tracheotomy is performed. And then, patient is switched to noninvasive ventilation by masking the tracheotomy tube. If the patient presents distress in noninvasive ventilation, he or she is switched to invasive ventilation. If the distress relieves, patient is switched to noninvasive ventilation again until the patient successfully weans from ventilator. In control group, the patient is weaned as the conventional methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: switching between invasive and noninvasive ventilationPatients in this group are received ventilator weaning by switching between invasive and noninvasive ventilation. |
| Control group | No intervention | –Patients in this group are weaned from ventilator as conventional methods. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- duration of invasive ventilation 5 to 7 days
- anticipation of difficult weaning
- Glasgow Coma Scale ≥13
- no upper airway obstruction
- presence of spontaneous breath
Key exclusion criteria (4 listed)
- age less than 18 or more than 85 years;
- contraindications for noninvasive ventilation;
- anticipation of survival less than 6 months;
- refusal of tracheotomy
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 |
|---|---|---|
| switching between invasive and noninvasive ventilationAs defined criteria, patients are switched between invasive and noninvasive ventilation until the ventilator is successfully weaned. | Procedure or surgery | Intervention group |
Primary outcome
ventilator weaning days
Time frame: from enrollment to 90 days
5 secondary outcomes
successful weaning rate
Time frame: from enrollment to 90 days
ICU stay days
Time frame: from admission to 90 days
hospital stay days
Time frame: from admission to 90 days
ICU mortality
Time frame: from admission to 90 days
hospital mortality
Time frame: from admission to 90 days
Results and safety
The study was stopped early (reason given: Difficult patient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- 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.
Shuliang Guo, MD 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?
A study testing switching between invasive and noninvasive ventilation in people with Ventilator Weaning, 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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 24 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?
The study was stopped early (reason given: Difficult patient enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ventilator weaning days (time frame: from enrollment to 90 days). 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 24 Mar 2026.