Prevalence of Tapia's Syndrome in Weaning Unit

NCT06033144 | Recruiting

• 1 other identifier: 2023-A00040-45
• Study Type: observational
• Target: 247
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tapia's Syndrome

Outcome Measures

Primary Outcomes (1)

• Prevalence of Tapia's syndrome

  The main objective of this study is to determine the prevalence of Tapia syndrome in patients admitted to the weaning unit after prolonged orotracheal intubation in intensive care. The orotracheal intubation is defined as an intubation longer than 48 hours.

  through study completion, an average of 2 years

Secondary Outcomes (7)

• Lingual involvment

  through study completion, an average of 2 years

• Soft palate involvement

  through study completion, an average of 2 years

• Determining the factors associated with Tapia syndrome

  The day of inclusion

• Dysphonia

  After initial swallowing test, maximum 1 week

• Dysphagia

  through study completion, an average of 2 years

Study Arms (2)

"Non Tapia group"

Patients without Tapia's syndrome

Diagnostic Test: Diagnosis of Tapia's Syndrome

"Tapia group"

Patient with Tapia's syndrome

Diagnostic Test: Diagnosis of Tapia's Syndrome

Interventions

Diagnosis of Tapia's Syndrome DIAGNOSTIC_TEST

The diagnostic includes : * Lingual clinical examination * Nasofibroscopy * Ultrasonography

"Non Tapia group"; "Tapia group"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Hospitalized in weaning unit
• Duration of orotracheal intubation in the ICU greater than 48 hours;
• Glasgow score greater than or equal to 13 ;
• Affiliation with a social security system or beneficiary of such a system ;
• Oral, free, informed and express consent of the patient.

You may not qualify if:

• 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;
• hour ventilated patient;
• Refusal of the patient or designated trusted person to participate in the study;
• Person subject to a safeguard of justice measure ;

Sponsors & Collaborators

• Hopital Forcilles: lead

Study Sites (1)

Hôpital Forcilles

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

RECRUITING

Related Publications (5)

• 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.

  PMID: 22179851 BACKGROUND

• 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.

  PMID: 32088986 BACKGROUND

• 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.

  PMID: 20098201 BACKGROUND

• 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.

  PMID: 35410105 BACKGROUND

• 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.

  PMID: 32518147 BACKGROUND

Central Study Contacts

Estelle ROBIN, SLT

CONTACT

01.60.64.62.41; erobin@cognacq-jay.fr

Aymeric LE NEINDRE, Dr

CONTACT

01.60.64.60.93; aleneindre@cognacq-jay.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: September 13, 2023
• Study Start: April 7, 2023
• Primary Completion: November 7, 2025
• Study Completion (Estimated): April 7, 2027
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)