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NCT Number: NCT06033144

Prevalence of Tapia's Syndrome in Weaning Unit

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Forcilles

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

Location status: Recruiting

Location contact

Agnès PEREIRA, SLT

PRINCIPAL_INVESTIGATOR

Aymeric LE NEINDRE, PhD

CONTACT

[email protected]

+33160646093

Estelle ROBIN, SLT

CONTACT

[email protected]

+33160646241

Gérald CHOUKROUN, MD

PRINCIPAL_INVESTIGATOR

Jean-Baptiste PERETOUT, MD

PRINCIPAL_INVESTIGATOR

Magalie BOUCHOUX, SLT

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 ;

Treatment and study plan

Diagnosis of Tapia's Syndrome

Diagnostic Test

The diagnostic includes :

  • Lingual clinical examination
  • Nasofibroscopy
  • Ultrasonography

Primary outcomes

  1. Prevalence of Tapia's syndrome

    Time frame: through study completion, an average of 2 years

    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.

Secondary outcomes

  1. Lingual involvment

    Time frame: through study completion, an average of 2 years

    yes/no/measure of lingual deviation in mm and width of each half of tongue in mm with MEEI software)

  2. Soft palate involvement

    Time frame: through study completion, an average of 2 years

    yes/no

  3. Determining the factors associated with Tapia syndrome

    Time frame: The day of inclusion

    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

  4. Dysphonia

    Time frame: After initial swallowing test, maximum 1 week

    GRBAS, maximum time of phonation (s), base frequency (Hz), jitter (%), harmonic noise ratio (dB), vocal range (dB), vocal tessitura (dB)

  5. Dysphagia

    Time frame: through study completion, an average of 2 years

    Functional oral intake scale (Level 1-Nothing by mouth to Level 7-Total oral diet with no restrictions)

  6. Nasofibroscopy

    Time frame: After initial swallowing test, maximum 1 week

    immobility of one or both vocal cords on nasofibroscopy

  7. Ultrasound

    Time frame: After initial swallowing test, maximum 1 week

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Aymeric LE NEINDRE, Dr

CONTACT

[email protected]

01.60.64.60.93

Estelle ROBIN, SLT

CONTACT

[email protected]

01.60.64.62.41

Sponsors and collaborators

Lead sponsor

Hopital Forcilles

Other

Registry information

Official study title

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

Acronym: PRESTIO

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Sep 13, 2023
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.