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

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

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 type: Observational
• Enrollment: 247 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hopital Forcilles (Academic / other)
• Locations: 1 site (Férolles-Attilly, Seine-et-Marne)
• Trial ID: NCT06033144 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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

Eligibility 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 this trial is running

Férolles-Attilly, Seine-et-Marne

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

Study contacts

• Study coordinator: Estelle ROBIN, SLT

Conditions Tapia's Syndrome