Prevalence of Tapia's Syndrome in Weaning Unit (PRESTIO)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Tapia's Syndrome
• Intervention / Treatment: Diagnostic test: Diagnosis of Tapia's Syndrome

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

• Study Type: Observational
• Enrollment (Estimated): 247

Contacts and Locations

• Study Contact: Name: Estelle ROBIN, SLT; Phone Number: 01.60.64.62.41; Email: erobin@cognacq-jay.fr
• Study Contact Backup: Name: Aymeric LE NEINDRE, Dr; Phone Number: 01.60.64.60.93; Email: aleneindre@cognacq-jay.fr

Study Locations

• France
  • Seine-et-Marne
    • Férolles-Attilly, Seine-et-Marne, France, 77150
      • Recruiting
      • Hôpital Forcilles
      • Principal Investigator: Jean-Baptiste PERETOUT, MD
      • Contact: Aymeric LE NEINDRE, PhD; Phone Number: +33160646093; Email: aleneindre@cognacq-jay.fr
      • Contact: Estelle ROBIN, SLT; Phone Number: +33160646241; Email: erobin@cogancq-jay.fr
      • Principal Investigator: Agnès PEREIRA, SLT
      • Principal Investigator: Magalie BOUCHOUX, SLT
      • Principal Investigator: Gérald CHOUKROUN, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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 ;

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
"Non Tapia group"; Patients without Tapia's syndrome	Diagnostic test: Diagnosis of Tapia's Syndrome; The diagnostic includes : Lingual clinical examination; Nasofibroscopy; Ultrasonography
"Tapia group"; Patient with Tapia's syndrome	Diagnostic test: Diagnosis of Tapia's Syndrome; The diagnostic includes : Lingual clinical examination; Nasofibroscopy; Ultrasonography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lingual involvment	yes/no/measure of lingual deviation in mm and width of each half of tongue in mm with MEEI software)	through study completion, an average of 2 years
Soft palate involvement	yes/no	through study completion, an average of 2 years
Determining the factors associated with Tapia syndrome	Determining the factors associated with Tapia syndrome : number of prone sessions, duration of intubation (day), duration of mechanical ventilation (day), tracheostomy duration (day), Cormack-Lehane's class, time to tracheostomy cannula removal (day), the time to resume oral feeding (day), number of days in the ICU, number of days in weaning unit, the number of pulmonary infections during the intubation and tracheostomy period, sex, the size of the intubation probe in mm	The day of inclusion
Dysphonia	GRBAS, maximum time of phonation (s), base frequency (Hz), jitter (%), harmonic noise ratio (dB), vocal range (dB), vocal tessitura (dB)	After initial swallowing test, maximum 1 week
Nasofibroscopy	immobility of one or both vocal cords on nasofibroscopy	After initial swallowing test, maximum 1 week
Ultrasound	hyoid-mandibular distance at rest and during swallowing in cm), tongue thickness at rest in cm, geniohyoidien thickness in mm and area in mm2, echogenicity (Heckmatt score), vallecula stasis (yes/no), stasis in the piriform sinuses (yes/no)	After initial swallowing test, maximum 1 week
Dysphagia	Functional oral intake scale (Level 1-Nothing by mouth to Level 7-Total oral diet with no restrictions)	through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Hopital Forcilles

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2023
• Primary Completion (Estimated): November 7, 2025
• Study Completion (Estimated): April 7, 2027

Study Registration Dates

• First Submitted: July 18, 2023
• First Submitted That Met QC Criteria: September 8, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: 2023-A00040-45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No