Clinical trial NCT06033144: Prevalence of Tapia's Syndrome in Weaning Unit
Official title: Prevalence of Tapia's Syndrome in Weaning Unit and Associated Factors After Orotracheal Intubation in the ICU
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Tapia's Syndrome
Lead sponsor: Hopital Forcilles
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 247
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who were intubated during more than 48 hours in ICU then tracheostomized and hospitalized in weaning unit.

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.

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

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 ;

Primary outcomes:
measure: Prevalence of Tapia's syndrome
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Lingual involvment
timeFrame: through study completion, an average of 2 years
measure: Soft palate involvement
timeFrame: through study completion, an average of 2 years
measure: Determining the factors associated with Tapia syndrome
timeFrame: The day of inclusion
measure: Dysphonia
timeFrame: After initial swallowing test, maximum 1 week
measure: Dysphagia
timeFrame: through study completion, an average of 2 years
measure: Nasofibroscopy
timeFrame: After initial swallowing test, maximum 1 week
measure: Ultrasound
timeFrame: After initial swallowing test, maximum 1 week
Other outcomes:
Locations:
city: Férolles-Attilly
country: France
facility: Hôpital Forcilles
state: Seine-et-Marne
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.