Prevalence of Tapia's Syndrome in Weaning Unit

NCT ID: NCT06033144

Last Updated: 2025-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

247 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-07

Study Completion Date

2027-04-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Tapia syndrome is a rare and poorly understood pathology. It is defined by a concomitant attack of the recurrent (branch of X) and hypoglossal (XII) nerves of peripheral or central origin. It is characterized by the paralysis of a vocal cord and the ipsilateral half of tongue. This damage is most often unilateral but it can also be bilateral. It results in dysphonia and swallowing disorders.

Tapia syndrome is a rare and poorly understood pathology. To date, less than 100 cases have been described in the literature. Previous works are mainly case reports and literature reviews. No prevalence study has been performed to date. Furthermore, disagreements persist regarding the semiology. Indeed, the involvement of the soft palate is not always described.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The main aim of this study was to determine the prevalence of Tapia syndrome in patients admitted to weaning unit after prolonged (\>48h) orotracheal intubation in the ICU.

The secondary objectives are to:

* Describe the clinical semiology of Tapia syndrome : lingual involvement, soft palate involvement, impairment of phonation and swallowing ;
* Describe the paraclinical features of Tapia syndrome: recurrent involvement, laryngeal and lingual involvement;
* Identify factors associated with Tapia's syndrome

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tapia's Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

"Non Tapia group"

Patients without Tapia's syndrome

Diagnosis of Tapia's Syndrome

Intervention Type DIAGNOSTIC_TEST

The diagnostic includes :

* Lingual clinical examination
* Nasofibroscopy
* Ultrasonography

"Tapia group"

Patient with Tapia's syndrome

Diagnosis of Tapia's Syndrome

Intervention Type DIAGNOSTIC_TEST

The diagnostic includes :

* Lingual clinical examination
* Nasofibroscopy
* Ultrasonography

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Diagnosis of Tapia's Syndrome

The diagnostic includes :

* Lingual clinical examination
* Nasofibroscopy
* Ultrasonography

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 ;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hopital Forcilles

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hôpital Forcilles

Férolles-Attilly, Seine-et-Marne, France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Estelle ROBIN, SLT

Role: CONTACT

01.60.64.62.41

Aymeric LE NEINDRE, Dr

Role: CONTACT

01.60.64.60.93

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Estelle ROBIN, SLT

Role: primary

+33160646241

Aymeric LE NEINDRE, PhD

Role: backup

+33160646093

References

Explore related publications, articles, or registry entries linked to this study.

Lykoudis EG, Seretis K. Tapia's syndrome: an unexpected but real complication of rhinoplasty: case report and literature review. Aesthetic Plast Surg. 2012 Jun;36(3):557-9. doi: 10.1007/s00266-011-9849-y. Epub 2011 Dec 17.

Reference Type BACKGROUND
PMID: 22179851 (View on PubMed)

De Luca P, Cavaliere M, Scarpa A, Savignano L, Cassandro E, Cassandro C, Iemma M. Rehabilitation Protocol for Unilateral Laryngeal and Lingual Paralysis (Tapia Syndrome): Comment About "A Challenging Case of Tapia Syndrome After Total Thyroidectomy" By Ildem Deveci, Mehmet Surmeli, and Reyhan Surmeli. Ear Nose Throat J. 2021 Sep;100(5_suppl):734S-737S. doi: 10.1177/0145561320907433. Epub 2020 Feb 23.

Reference Type BACKGROUND
PMID: 32088986 (View on PubMed)

Boga I, Aktas S. Treatment, classification, and review of Tapia syndrome. J Craniofac Surg. 2010 Jan;21(1):278-80. doi: 10.1097/SCS.0b013e3181c678f0.

Reference Type BACKGROUND
PMID: 20098201 (View on PubMed)

Caranti A, Bianchini C, Corazzi V, Pelucchi S, Ciorba A. Tapia's Syndrome: keep it in mind! Minerva Anestesiol. 2022 Apr;88(4):293-299. doi: 10.23736/S0375-9393.21.16037-7.

Reference Type BACKGROUND
PMID: 35410105 (View on PubMed)

Decavel P, Petit C, Tatu L. Tapia syndrome at the time of the COVID-19 pandemic: Lower cranial neuropathy following prolonged intubation. Neurology. 2020 Aug 18;95(7):312-313. doi: 10.1212/WNL.0000000000010011. Epub 2020 Jun 9. No abstract available.

Reference Type BACKGROUND
PMID: 32518147 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023-A00040-45

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.