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Recruiting NCT06033144

Prevalence of Tapia's Syndrome in Weaning Unit

— Observational Tapia's Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Diagnosis of Tapia's Syndrome.
Who it may be relevant to
Registry conditions: Tapia's Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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

Interventions

  • Diagnostic test Diagnosis of Tapia's Syndrome
    The diagnostic includes : * Lingual clinical examination * Nasofibroscopy * Ultrasonography

Primary outcome measures

  • Prevalence of Tapia's syndrome [Time frame: through study completion, an average of 2 years]
Secondary outcome measures (7)
  • Lingual involvment [Time frame: through study completion, an average of 2 years]
  • Soft palate involvement [Time frame: through study completion, an average of 2 years]
  • Determining the factors associated with Tapia syndrome [Time frame: The day of inclusion]
  • Dysphonia [Time frame: After initial swallowing test, maximum 1 week]
  • Dysphagia [Time frame: through study completion, an average of 2 years]
  • Nasofibroscopy [Time frame: After initial swallowing test, maximum 1 week]
  • Ultrasound [Time frame: After initial swallowing test, maximum 1 week]

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 ;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Hôpital Forcilles — Férolles-Attilly

Publications

  • 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
  • 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 PMID 32088986
  • 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
  • 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
  • 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

Identifiers

NCT: NCT06033144 · 2023-A00040-45

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗