Clinical trial Recruiting at 1 site Observational Ages 18 and up

How common Tapia's syndrome is after prolonged breathing tube use in the weaning unit

Official title: Prevalence of Tapia's Syndrome in Weaning Unit and Associated Factors After Orotracheal Intubation in the ICU

Run by Hopital Forcilles · NCT06033144 · Data updated 2026-11-12

This project will see how often Tapia's syndrome occurs in adults who had an orotracheal tube for more than 48 hours and are admitted to a weaning unit.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment247 (estimated)
SponsorHopital Forcilles
Academic / other
Locations1 site (Férolles-Attilly, Seine-et-Marne)
StatusRecruiting
StartedApril 7, 2023
Main results expectedApril 7, 2027
Study endsNovember 7, 2027
Registry record updatedSeptember 23, 2026
Trial IDNCT06033144 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18) admitted to the weaning unit after more than 48 hours of orotracheal intubation with a Glasgow score ≥13 who can give informed consent are the intended participants.

Probably not a fit

People with prior ENT or neurological disorders, tumors near the X‑nerve pathway, or other listed exclusion conditions (or those who decline participation) are unlikely to benefit from this prevalence study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center observational prevalence study of Tapia's syndrome in patients admitted to a weaning unit after prolonged (>48 hours) orotracheal intubation in the ICU. Eligible adults will undergo focused clinical and paraclinical evaluation to identify recurrent (X) and hypoglossal (XII) nerve involvement, including assessments of tongue movement, vocal cord function, swallowing, and soft palate involvement. The study will record clinical features, laryngeal and lingual findings, and collect data on potential risk factors to describe the syndrome's semiology and associated conditions. Results will estimate how common Tapia's syndrome is in this population and characterize typical presentations.

Why it matters

Potential benefit: If successful, the findings could help clinicians recognize Tapia's syndrome earlier and guide management of voice and swallowing problems after prolonged intubation.

How similar studies have gone: This area is largely untested for prevalence; published literature is limited to case reports and reviews and no prior prevalence study has been done.

Who can join: the full rules

Show full inclusion / exclusion criteria
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 ;

Where it's running

  • Hôpital Forcilles
    Férolles-Attilly, Seine-et-Marne, France
    Recruiting

Study contacts

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.