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Rare nerve damage after ICU breathing tubes: first large study launched

NCT ID NCT06033144

Knowledge-focused Sponsor: Hopital Forcilles Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study aims to measure how common Tapia's syndrome is in patients who had a breathing tube for more than 48 hours in the ICU. Tapia's syndrome causes paralysis of one vocal cord and half the tongue, leading to voice and swallowing problems. Researchers will examine 247 patients using tongue exams, a scope, and ultrasound to diagnose the condition and identify factors that may increase the risk.

What this could mean

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

What this could lead to
If successful, this study could provide the first reliable data on how common Tapia's syndrome is and what factors increase the risk, helping doctors recognize and manage it earlier.
What could go wrong
This is an observational study, not a treatment trial, so it won't test any therapy. The findings may not apply to all ICU patients, and the condition is so rare that even with 247 participants, the numbers may be too small for strong conclusions.

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.

Participants

About 247 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Apr 2027

An estimate. End dates often move.

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.

Who is studied

Patients who were intubated during more than 48 hours in ICU then tracheostomized and hospitalized in weaning unit.

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: * Hospitalized in weaning unit * Duration of orotracheal intubation in the ICU greater than 48 hours; * Glasgow score greater than or equal to 13 ; * Patient at least 18 years of age at the time of inclusion; * Affiliation with a social security system or beneficiary of such a system ; * Oral, free, informed and express consent of the patient. Exclusion Criteria: * Known history of ENT or neurological pathologies (stroke, head trauma, neurodegenerative disease, brain tumor, ENT cancer); * Known tumors in the vicinity of the X-nerve pathway; * Ortner's syndrome (left recurrent nerve compression through the left atrium in mitral stenosis); * Left lung cancer with subaortic lesion; * History of cervical adenopathy compressing the X nerve; * Presence of a cervical or cerebral abscess; * 24-hour ventilated patient; * Refusal of the patient or designated trusted person to participate in the study; * Person subject to a safeguard of justice measure ;

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As listed by the trial registrant

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

Tapia's syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hôpital Forcilles

    RECRUITING

    Férolles-Attilly, Seine-et-Marne, 77150, France