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Набор по приглашению NCT07131800

Objective and Perceptual Characteristics of the Voice After Endotracheal Intubation in Head and Neck Surgery

— Наблюдательное Voice Disorder Due to Iatrogenic Factor Endotracheal Intubation During Surgery Thyroid Surgery Head and Neck Surgery

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Voice Disorder Due to Iatrogenic Factor, Endotracheal Intubation During Surgery, Thyroid Surgery, Head and Neck Surgery. Базовые параметры: 18 лет — 70 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
Хорватия
Следующий шаг
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Обзор

Introduction: Possible consequences of endotracheal intubation are post-intubation voice changes. Hypothesis: Endotracheal intubation during head and neck surgery is associated with objective and perceptual voice disorders. Research objective: To investigate the short-term and long-term effects of endotracheal intubation on voice quality during head and neck surgery. Material, subjects, methodology and research design: A prospective observational cohort study that will include patients undergoing surgery and endotracheal intubation lasting up to 3 hours. Adult patients divided into three groups will be included in the research: thyroid surgery, parotid gland surgery and abdominal surgery. Videostroboscopy, perceptual and objective acoustic voice analysis will be recorded before surgery, on the second postoperative day, two weeks and 1 month after surgery. Expected scientific contribution of the proposed research: The scientific contribution would be an understanding of the risk factors and the connection of voice disorders after endotracheal intubation, as well as the ability to determine differences in this risk in patients undergoing different operations.

Подробное описание

study protocol has been published and is attached below

Первичные конечные точки

  • Subjective analysis of voice changes before and after endotracheal intubation for thyroid surgery, other head and neck surgery and abdominal surgery using Voice Handicap Index (VHI) [Срок оценки: Preoperative (within 7 days before surgery), Postoperative Day 1, Week 2, and Week 4]
  • Subjective analysis of voice changes before and after endotracheal intubation for thyroid surgery, other head and neck surgery and abdominal surgery using GRBAS Scale (Perceptual Voice Evaluation) [Срок оценки: Time Points: Preoperative (within 7 days before surgery), Postoperative Day 1, Week 2, and Week 4]
  • Videostroboscopy Evaluation before and after surgery [Срок оценки: Preoperative (within 7 days before surgery) and Postoperative day 1]
  • Objective Acoustic and Aerodynamic Voice Analysis - changes in fundamental frequency before and after surgery [Срок оценки: Time Points: Preoperative (within 7 days before surgery), Postoperative Day 1, Week 2, and Week 4]
Вторичные конечные точки (4)
  • Objective Acoustic and Aerodynamic Voice Analysis - changes in Intensity before and after surgery [Срок оценки: Time Points: Preoperative (within 7 days before surgery), Postoperative Day 1, Week 2, and Week 4]
  • Objective Acoustic and Aerodynamic Voice Analysis- changes in Jitter before and after surgery [Срок оценки: Time Points: Preoperative (within 7 days before surgery), Postoperative Day 1, Week 2, and Week 4]
  • Objective Acoustic and Aerodynamic Voice Analysis- changes in shimmer before and after surgery [Срок оценки: Time Points: Preoperative (within 7 days before surgery), Postoperative Day 1, Week 2, and Week 4]
  • Objective Acoustic and Aerodynamic Voice Analysis- changes in Maximum phonation time before and after surgery [Срок оценки: Time Points: Preoperative (within 7 days before surgery), Postoperative Day 1, Week 2, and Week 4]

Критерии участия

Критерии включения

  • patients scheduled for elective thyroid, head and neck surgery or abdominal surgery
  • 18 and 70 years,
  • normal preoperative voice status, and
  • normal laryngeal status.

Критерии исключения

  • <18 years in the time of surgery
  • history of previous head and neck operation or radiotherapy
  • patients scheduled for head and neck operation that can alter acoustic characteristics of the voice (surgery of the nasal cavity, ear surgery, laryngeal surgery, jaw surgery).
  • Patients with preoperatively diagnosed pathologic vocal cord findings (nodules, polyps, vocal cord paralysis),
  • patients with postoperative injuries of the vocal cords, recurrent and superior laryngeal nerve,
  • patients with laryngopharyngeal reflux,
  • patients in whom postoperative evaluation of the voice cannot be performed due to uncooperativeness will also be excluded from the study.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Хорватия · 1 центр
  • University Hospital Centre Zagreb — Zagreb

Публикации

  • Simic I, Curic Radivojevic R, Slipac J, Prgomet D. VOICE CONDITION FOLLOWING SHORT-TERM ENDOTRACHEAL INTUBATION IN HEAD AND NECK SURGERY: STUDY PROTOCOL FOR CLINICAL TRIAL. Acta Clin Croat. 2023 Apr;62(Suppl1):49-54. doi: 10.20471/acc.2023.62.s1.06. PMID 38746618

Идентификаторы

NCT: NCT07131800 · Klasa8.1-23/209-3;Broj02/013AG

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗