Prolonged Mechanical VentilationNCT06642714
Standardized Tracheostomy Weaning Protocol for Prolonged Mechanical Ventilation
A study testing Standardized Stepwise Weaning Protocol in people with Prolonged Mechanical Ventilation and Ventilator Weaning, run by Capital Medical University at 1 site in China.
Trial summary
This study evaluated the feasibility and clinical outcomes of a standardized weaning protocol for tracheostomized patients requiring prolonged mechanical ventilation. The protocol was delivered in a specialized weaning unit of a tertiary rehabilitation hospital and combined early noninvasive ventilation, progressive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prolonged Mechanical Ventilation, Ventilator Weaning, Tracheostomy
- What is being tested?
- Standardized Stepwise Weaning Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 30 Mar 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older;
- Tracheostomy in place at the time of referral or enrollment;
- Prolonged mechanical ventilation, defined according to the National Association for Medical Direction of Respiratory Care consensus as the need for invasive mechanical ventilation for more than 6 hours per day for at least 21 consecutive days;
- Consecutively referred or admitted to the specialized weaning unit between January 1, 2025 and October 31, 2025 for active weaning rehabilitation;
- Written informed consent provided by the participant or the participant's legally authorized representative.
Who cannot join
- Referral intended solely for clinical stabilization before discharge to home or nursing care rather than for an active weaning attempt;
- End-stage disease with life expectancy of less than 3 months;
- Death or discharge within 14 days after referral;
- Refusal to provide informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Rehabilitation Hospital of Capital Medical University
Beijing
About this study
Official title: Early Noninvasive Ventilation and Progressive High-Flow Oxygen Therapy Through a Tracheostomy Tube Weaning Protocol in Tracheostomized Patients With Prolonged Mechanical Ventilation: A Prospective Single-Arm Interventional Study
This study evaluated the feasibility and clinical outcomes of a standardized weaning protocol for tracheostomized patients requiring prolonged mechanical ventilation. The protocol was delivered in a specialized weaning unit of a tertiary rehabilitation hospital and combined early noninvasive ventilation, progressive high-flow oxygen therapy through the tracheostomy tube, spontaneous breathing trials when appropriate, and stepwise reduction of ventilatory support. The main outcome was successful liberation from mechanical ventilation within 60 days.
Read the detailed description
Patients who require prolonged mechanical ventilation after tracheostomy often have respiratory muscle weakness, impaired load-capacity balance, multiple comorbidities, and a high risk of delayed liberation from mechanical ventilation. These patients may have difficulty tolerating abrupt transition to unsupported breathing, and conventional weaning approaches may not be sufficient for all patients.
This study was conducted in a specialized weaning unit of a tertiary rehabilitation hospital. The intervention was a standardized, stepwise weaning protocol for tracheostomized patients with prolonged mechanical ventilation. The protocol included daily assessment of clinical stability and readiness for weaning, gradual reduction of ventilatory support, early use of noninvasive ventilation when appropriate, progressive high-flow oxygen therapy delivered through the tracheostomy tube, spontaneous breathing trials when clinically feasible, airway clearance, rehabilitation, nutritional support, and multidisciplinary reassessment.
The purpose of the protocol was to facilitate safe liberation from mechanical ventilation while minimizing the risk of weaning failure and early reconnection to ventilatory support. Participants were followed for weaning outcomes, reconnection after successful weaning, survival status, and other clinical outcomes according to the study protocol.
- Being tested
- Standardized Stepwise Weaning Protocol
- Keywords
- Prolonged mechanical ventilation, Tracheostomy, Ventilator weaning, Noninvasive ventilation, High-flow oxygen therapy, Specialized weaning unit, Rehabilitation hospital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Stepwise Weaning ProtocolOther
The intervention was a standardized stepwise weaning protocol for tracheostomized patients requiring prolonged mechanical ventilation. Clinical stability and readiness for weaning were assessed before protocol initiation. Ventilator support was gradually reduced according to patient tolerance. When patients met predefined readiness criteria, spontaneous breathing trials were performed under pressure support ventilation. Patients who tolerated spontaneous breathing trials transitioned to progressively longer periods of high-flow oxygen therapy delivered through the tracheostomy tube. Noninvasive ventilation was used when appropriate to support transition from invasive ventilation and facilitate liberation from ventilatory support. Patients were reconnected to the ventilator if signs of respiratory distress or clinical instability occurred. Airway clearance, rehabilitation, nutritional support, and multidisciplinary reassessment were integrated throughout the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Standardized Weaning Protocol | Experimental | Participants in this single-group study received a standardized stepwise weaning protocol in a specialized weaning unit. The protocol included daily assessment of clinical stability and weaning readiness, gradual reduction of ventilatory support, spontaneous breathing trials when clinically feasible, early noninvasive ventilation when appropriate, progressive high-flow oxygen therapy through the tracheostomy tube, airway clearance, rehabilitation, nutritional support, and multidisciplinary reassessment. Receives: Other: Standardized Stepwise Weaning Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Successful Weaning Within 60 Days
Successful weaning was defined as breathing without invasive mechanical ventilator assistance for at least 5 consecutive days. The outcome was calculated as the percentage of enrolled participants who achieved successful weaning within 60 days after enrollment.
Measured: From enrollment to 60 days after enrollment
Secondary outcomes (3)
Time From Enrollment to Successful Weaning
Weaning duration was defined as the number of days from enrollment to the first day on which the participant met the definition of successful weaning.
Measured: From enrollment to successful weaning, assessed up to 60 days after enrollment
Percentage of Successfully Weaned Participants Reconnected to Invasive Ventilation Within 30 Days
Reconnection was defined as the need to resume invasive mechanical ventilator assistance within 30 days after successful weaning. This outcome was calculated among participants who achieved successful weaning.
Measured: From successful weaning to 30 days after successful weaning
All-Cause Mortality at 6 Months
All-cause mortality was defined as death from any cause within 6 months after enrollment.
Measured: From enrollment to 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Jan 2025
- Primary completion31 Dec 2025
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prolonged 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single-group interventional study evaluating a standardized stepwise weaning protocol in tracheostomized patients requiring prolonged mechanical ventilation in a specialized weaning unit.
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingyi Ge, Capital Medical University
- Investigators
- Jingyi Ge, Principal investigator, Study Principal InvestigatorJingyi Ge, Principal investigator, Beijing Rehabilitation Hospital of Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642714
- Sponsor's protocol ID
- 2025Z-001
- Status last verified
- May 2026
- First submitted
- 9 Oct 2024
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang C, Zhang R, Ge J, Li Q, Yang B, Zhang B, Wang J, Zhou T, Jiang H. Effectiveness of a standardized weaning protocol in tracheostomized patients with prolonged mechanical ventilation: a prospective single-arm interventional trial. J Intensive Care. 2026 Sep 2;14(1):95. doi: 10.1186/s40560-026-00935-x.
PubMed 42687196
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Noninvasive Ventilation and Progressive High-Flow Oxygen Therapy Through a Tracheostomy Tube Weaning Protocol in Tracheostomized Patients With Prolonged Mechanical Ventilation: A Prospective Single-Arm Interventional Study
- ClinicalTrials.gov ID
- NCT06642714
- Acronym / sponsor ID
- 2025Z-001
- Keywords
- Prolonged mechanical ventilation, Tracheostomy, Ventilator weaning, Noninvasive ventilation, High-flow oxygen therapy, Specialized weaning unit, Rehabilitation hospital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 15 Oct 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 evaluated the feasibility and clinical outcomes of a standardized weaning protocol for tracheostomized patients requiring prolonged mechanical ventilation. The protocol was delivered in a specialized weaning unit of a tertiary rehabilitation hospital and combined early noninvasive ventilation, progressive high-flow oxygen therapy through the tracheostomy tube, spontaneous breathing trials when appropriate, and stepwise reduction of ventilatory support. The main outcome was successful liberation from mechanical ventilation within 60 days.
Detailed description
Patients who require prolonged mechanical ventilation after tracheostomy often have respiratory muscle weakness, impaired load-capacity balance, multiple comorbidities, and a high risk of delayed liberation from mechanical ventilation. These patients may have difficulty tolerating abrupt transition to unsupported breathing, and conventional weaning approaches may not be sufficient for all patients.
This study was conducted in a specialized weaning unit of a tertiary rehabilitation hospital. The intervention was a standardized, stepwise weaning protocol for tracheostomized patients with prolonged mechanical ventilation. The protocol included daily assessment of clinical stability and readiness for weaning, gradual reduction of ventilatory support, early use of noninvasive ventilation when appropriate, progressive high-flow oxygen therapy delivered through the tracheostomy tube, spontaneous breathing trials when clinically feasible, airway clearance, rehabilitation, nutritional support, and multidisciplinary reassessment.
The purpose of the protocol was to facilitate safe liberation from mechanical ventilation while minimizing the risk of weaning failure and early reconnection to ventilatory support. Participants were followed for weaning outcomes, reconnection after successful weaning, survival status, and other clinical outcomes according to the study protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-group interventional study evaluating a standardized stepwise weaning protocol in tracheostomized patients requiring prolonged mechanical ventilation in a specialized weaning unit.
| Arm | Type | Receives |
|---|---|---|
| Standardized Weaning Protocol | Experimental | Other: Standardized Stepwise Weaning ProtocolParticipants in this single-group study received a standardized stepwise weaning protocol in a specialized weaning unit. The protocol included daily assessment of clinical stability and weaning readiness, gradual reduction of ventilatory support, spontaneous breathing trials when clinically feasible, early noninvasive ventilation when appropriate, progressive high-flow oxygen therapy through the tracheostomy tube, airway clearance, rehabilitation, nutritional support, and multidisciplinary reassessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older;
- Tracheostomy in place at the time of referral or enrollment;
- Prolonged mechanical ventilation, defined according to the National Association for Medical Direction of Respiratory Care consensus as the need for invasive mechanical ventilation for more than 6 hours per day for at least 21 consecutive days;
- Consecutively referred or admitted to the specialized weaning unit between January 1, 2025 and October 31, 2025 for active weaning rehabilitation;
- Written informed consent provided by the participant or the participant's legally authorized representative.
Key exclusion criteria (4 listed)
- Referral intended solely for clinical stabilization before discharge to home or nursing care rather than for an active weaning attempt;
- End-stage disease with life expectancy of less than 3 months;
- Death or discharge within 14 days after referral;
- Refusal to provide informed consent.
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 |
|---|---|---|
| Standardized Stepwise Weaning ProtocolThe intervention was a standardized stepwise weaning protocol for tracheostomized patients requiring prolonged mechanical ventilation. Clinical stability and readiness for weaning were assessed before protocol initiation. Ventilator support was gradually reduced according to patient tolerance. When patients met predefined readiness criteria, spontaneous breathing trials were performed under pressure support ventilation. Patients who tolerated spontaneous breathing trials transitioned to progressively longer periods of high-flow oxygen therapy delivered through the tracheostomy tube. Noninvasive ventilation was used when appropriate to support transition from invasive ventilation and facilitate liberation from ventilatory support. Patients were reconnected to the ventilator if signs of respiratory distress or clinical instability occurred. Airway clearance, rehabilitation, nutritional support, and multidisciplinary reassessment were integrated throughout the protocol. | Other | Standardized Weaning Protocol |
Primary outcome
Percentage of Participants With Successful Weaning Within 60 Days
Time frame: From enrollment to 60 days after enrollment
Successful weaning was defined as breathing without invasive mechanical ventilator assistance for at least 5 consecutive days. The outcome was calculated as the percentage of enrolled participants who achieved successful weaning within 60 days after enrollment.
3 secondary outcomes
Time From Enrollment to Successful Weaning
Time frame: From enrollment to successful weaning, assessed up to 60 days after enrollment
Percentage of Successfully Weaned Participants Reconnected to Invasive Ventilation Within 30 Days
Time frame: From successful weaning to 30 days after successful weaning
All-Cause Mortality at 6 Months
Time frame: From enrollment to 6 months after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Derived from this study: PubMed 42687196Zhang C, Zhang R, Ge J, Li Q, Yang B, Zhang B, Wang J, Zhou T, Jiang H. Effectiveness of a standardized weaning protocol in tracheostomized patients with prolonged mechanical ventilation: a prospective single-arm interventional trial. J Intensive Care. 2026 Sep 2;14(1):95. doi: 10.1186/s40560-026-00935-x.
- Individual participant dataSharing planned: No
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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.
Jingyi Ge principal investigator
Study Principal Investigator
Jingyi Ge principal investigator
Beijing Rehabilitation Hospital of Capital 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 Standardized Stepwise Weaning Protocol in people with Prolonged Mechanical Ventilation and Ventilator Weaning, run by Capital 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: finished, as of the sponsor's last update on 28 May 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of Participants With Successful Weaning Within 60 Days (time frame: From enrollment to 60 days after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06642714, which also lists 1 linked publication.
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 28 May 2026.