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Prevalence of Tapia's Syndrome in Weaning Unit

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06033144
Acronym
PRESTIO
Enrollment
247
Registered
2023-09-13
Start date
2023-04-07
Completion date
2027-04-07
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tapia's Syndrome

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

Interventions

DIAGNOSTIC_TESTDiagnosis of Tapia's Syndrome

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

Sponsors

Hopital Forcilles
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 ;

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of Tapia's syndromethrough study completion, an average of 2 yearsThe 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

MeasureTime frameDescription
Soft palate involvementthrough study completion, an average of 2 yearsyes/no
Determining the factors associated with Tapia syndromeThe day of inclusionDetermining 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
DysphoniaAfter initial swallowing test, maximum 1 weekGRBAS, maximum time of phonation (s), base frequency (Hz), jitter (%), harmonic noise ratio (dB), vocal range (dB), vocal tessitura (dB)
Lingual involvmentthrough study completion, an average of 2 yearsyes/no/measure of lingual deviation in mm and width of each half of tongue in mm with MEEI software)
NasofibroscopyAfter initial swallowing test, maximum 1 weekimmobility of one or both vocal cords on nasofibroscopy
UltrasoundAfter initial swallowing test, maximum 1 weekhyoid-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)
Dysphagiathrough study completion, an average of 2 yearsFunctional oral intake scale (Level 1-Nothing by mouth to Level 7-Total oral diet with no restrictions)

Countries

France

Contacts

Primary ContactEstelle ROBIN, SLT
erobin@cognacq-jay.fr01.60.64.62.41
Backup ContactAymeric LE NEINDRE, Dr
aleneindre@cognacq-jay.fr01.60.64.60.93

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026