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New oxygen method could help brain patients breathe easier without a ventilator

NCT ID NCT07257016

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at whether giving warm, moist oxygen at a high flow rate through a breathing tube is safe and works well for brain-injured patients in the intensive care unit. These patients could breathe on their own but still needed the tube to protect their airway. The goal was to see if this method could help them avoid the risks of staying on a ventilator too long. 24 adults who had brain surgery or injury took part.

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

24 people

The number who actually took part.

Started

Dec 2025

Finished

Apr 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. * Post-neurosurgical or brain injury patients with stable intracranial status (Glasgow Coma Scale ≥ 9, Richmond Agitation-Sedation Scale score -2 to +1). * Successful completion of a 30-minute T-piece spontaneous breathing trial (per standard SBT failure criteria). * Poor airway protection capacity (STAGE score \< 6) necessitates ongoing intubation for respiratory support, as determined by the attending physician. * Signed informed consent (by patient or legal representative). Exclusion Criteria: * Contraindications to esophageal pressure monitoring (e.g., esophageal varices, recent esophageal surgery). * History of chronic respiratory diseases (e.g., COPD, severe asthma). * Chronic heart failure (NYHA class III-IV) or severe arrhythmia. * Body Mass Index (BMI) \> 30 kg/m². * Pregnancy. * Anticipated need for tracheostomy without extubation attempt * Withdrawal of life-sustaining treatment

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As listed by the trial registrant

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

Contacts and locations

Locations

  • Capital Medical University Beijing Tiantan Hospital

    Beijing, 100070, China

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