New feeding tube method may help tracheotomy patients swallow again and remove breathing tube sooner

NCT ID NCT06791590

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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.
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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 Results may not be published yet.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)

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Expanded access (paused)
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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

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Status unknown
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First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This study compares two ways of feeding patients who have a tracheotomy (a tube in the windpipe) and swallowing problems caused by nerve damage. One method uses a tube placed through the mouth into the esophagus (intermittent oro-esophageal, or IOE), while the other uses a tube through the nose into the intestine. The main goal is to see which method helps patients remove their tracheotomy tube faster and improves swallowing safety. The trial enrolls 140 adults whose acute illness has passed and who are ready to start the decannulation process.

What this could mean

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

Active substance
intermittent oro-esophageal tube feeding (IOE)
What this could lead to
If IOE proves better, it could become a standard nutrition method that helps tracheotomy patients with swallowing problems remove their breathing tube faster and improve quality of life.
What could go wrong
This is a single-center study with 140 participants, so results may not apply broadly. IOE requires patient cooperation and may not be suitable for everyone.

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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

140 people

The number who actually took part.

Started

Jan 2025

Finished

Dec 2025

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 to 92 years

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: * Diagnosis of neurogenic dysphagia; * Acute phase has passed, weaning time \> 48 hours, tracheotomy time \>1 week; in accordance with the decannulation process of tracheotomy patients formulated by our center in 2018; * steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment; * Gastrointestinal motility is good, can tolerate more than 150ml/h feeding pump speed; * Willing to sign an informed consent form. Exclusion Criteria: * Structural swallowing disorders, such as oral, pharyngeal, larynx, esophagus and other anatomical abnormalities caused by swallowing disorders; * The clinical condition was unstable, accompanied by heart, lung, brain and other important organ dysfunction; * Severe cognitive dysfunction, confusion, unable to cooperate.

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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

  • Beijing Rehabilitation Hospital, Capital Medical University

    Beijing, China

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