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Идёт набор NCT06033144

Prevalence of Tapia's Syndrome in Weaning Unit

— Наблюдательное Tapia's Syndrome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Diagnosis of Tapia's Syndrome.
Кому может быть актуально
Состояния в реестре: Tapia's Syndrome. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

  • Диагностический тест Diagnosis of Tapia's Syndrome
    The diagnostic includes : * Lingual clinical examination * Nasofibroscopy * Ultrasonography

Первичные конечные точки

  • Prevalence of Tapia's syndrome [Срок оценки: through study completion, an average of 2 years]
Вторичные конечные точки (7)
  • Lingual involvment [Срок оценки: through study completion, an average of 2 years]
  • Soft palate involvement [Срок оценки: through study completion, an average of 2 years]
  • Determining the factors associated with Tapia syndrome [Срок оценки: The day of inclusion]
  • Dysphonia [Срок оценки: After initial swallowing test, maximum 1 week]
  • Dysphagia [Срок оценки: through study completion, an average of 2 years]
  • Nasofibroscopy [Срок оценки: After initial swallowing test, maximum 1 week]
  • Ultrasound [Срок оценки: After initial swallowing test, maximum 1 week]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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 ;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Hôpital Forcilles — Férolles-Attilly

Публикации

  • 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. PMID 22179851
  • 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 PMID 32088986
  • 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. PMID 20098201
  • 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. PMID 35410105
  • 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. PMID 32518147

Идентификаторы

NCT: NCT06033144 · 2023-A00040-45

Первоисточники (государственные реестры)

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