Tapia's SyndromePRESTIONCT06033144
Prevalence of Tapia's Syndrome in Weaning Unit
An observational study of Tapia's Syndrome, run by Hopital Forcilles at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tapia's Syndrome
- What is being tested?
- Diagnosis of Tapia's Syndrome
- How many people
- 247 participants
- Where
- 1 siteFrance
- Study dates
- 7 Apr 2023to 7 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were intubated during more than 48 hours in ICU then tracheostomized and hospitalized in weaning unit.
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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 ;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Forcilles
Férolles-Attilly, Seine-et-Marne, 77150
Estelle ROBIN, SLT, +33160646241, erobin@cogancq-jay.fr
Aymeric LE NEINDRE, PhD, +33160646093, aleneindre@cognacq-jay.fr
About this study
Official title: 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.
Read the 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
- Conditions
- Tapia's Syndrome
- Being tested
- Diagnosis of Tapia's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosis of Tapia's SyndromeDiagnostic test
The diagnostic includes :
- Lingual clinical examination
- Nasofibroscopy
- Ultrasonography
| Study group | Role | What they receive |
|---|---|---|
| "Non Tapia group" | Patients without Tapia's syndrome Receives: Diagnostic Test: Diagnosis of Tapia's Syndrome | |
| "Tapia group" | Patient with Tapia's syndrome Receives: Diagnostic Test: Diagnosis of Tapia's Syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 2 years
Secondary outcomes (7)
Lingual involvment
yes/no/measure of lingual deviation in mm and width of each half of tongue in mm with MEEI software)
Measured: through study completion, an average of 2 years
Soft palate involvement
yes/no
Measured: 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
Measured: 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)
Measured: 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)
Measured: through study completion, an average of 2 years
Nasofibroscopy
immobility of one or both vocal cords on nasofibroscopy
Measured: 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)
Measured: After initial swallowing test, maximum 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start7 Apr 2023
- Primary completion7 Apr 2027 (estimated)
- Study completion7 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Tapia's SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 247 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Forcilles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033144
- Sponsor's protocol ID
- 2023-A00040-45
- Acronym
- PRESTIO
- Status last verified
- Sep 2026
- First submitted
- 18 Jul 2023
- Last updated
- 23 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 22179851De 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.
PubMed 32088986Boga I, Aktas S. Treatment, classification, and review of Tapia syndrome. J Craniofac Surg. 2010 Jan;21(1):278-80. doi: 10.1097/SCS.0b013e3181c678f0.
PubMed 20098201Caranti 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.
PubMed 35410105Decavel 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.
PubMed 32518147
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Tapia's Syndrome in Weaning Unit and Associated Factors After Orotracheal Intubation in the ICU
- ClinicalTrials.gov ID
- NCT06033144
- Acronym / sponsor ID
- PRESTIO / 2023-A00040-45
- Conditions
- Tapia's Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 247 participants (estimated)
- Lead sponsor
- Hopital ForcillesUniversity, hospital or other
- Study start
- 7 Apr 2023 (actual)
- Primary completion
- 7 Apr 2027 (estimated)
- Study completion
- 7 Nov 2027 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Non Tapia group" | – | Diagnostic Test: Diagnosis of Tapia's SyndromePatients without Tapia's syndrome |
| "Tapia group" | – | Diagnostic Test: Diagnosis of Tapia's SyndromePatient with Tapia's syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were intubated during more than 48 hours in ICU then tracheostomized and hospitalized in weaning unit.
Key inclusion criteria (6 listed)
- 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 ;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnosis of Tapia's SyndromeThe diagnostic includes : * Lingual clinical examination * Nasofibroscopy * Ultrasonography | Diagnostic test | "Non Tapia group", "Tapia group" |
Primary outcome
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Background: PubMed 22179851Lykoudis 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.
- Background: PubMed 32088986De 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.
- Background: PubMed 20098201Boga I, Aktas S. Treatment, classification, and review of Tapia syndrome. J Craniofac Surg. 2010 Jan;21(1):278-80. doi: 10.1097/SCS.0b013e3181c678f0.
- Background: PubMed 35410105Caranti 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.
- Background: PubMed 32518147Decavel 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tapia's Syndrome, run by Hopital Forcilles at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Estelle ROBIN, SLT (01.60.64.62.41, erobin@cognacq-jay.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Tapia's syndrome (time frame: through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06033144, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.