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New weaning protocol offers hope for Ventilator-Dependent patients

NCT ID NCT06642714

Disease control Sponsor: Capital Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a structured weaning protocol for 250 tracheostomy patients who needed a ventilator for more than 21 days. The protocol gradually reduced ventilator support and used noninvasive ventilation and high-flow oxygen through the tracheostomy tube. The goal was to help patients breathe on their own for at least 5 days within 60 days. The results could lead to a safer, more effective way to wean patients off long-term ventilation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Standardized stepwise weaning protocol (noninvasive ventilation and high-flow oxygen therapy)
What this could lead to
If successful, this protocol could help more tracheostomy patients safely come off ventilators, reducing complications and improving recovery.
What could go wrong
This was a single-arm study without a comparison group, so results may not apply to all patients. The protocol requires specialized care, and some patients may not tolerate the weaning process.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

250 people

The number who actually took part.

Started

Jan 2025

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prolonged mechanical ventilation Tracheostomy Ventilator weaning

Contacts and locations

Locations

  • Beijing Rehabilitation Hospital of Capital Medical University

    Beijing, China

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