Effects of Thyroidectomy on Obstructive Sleep Apnea in Patients Suffering From Goiters
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: polysomnography.
- Кому может быть актуально
- Состояния в реестре: Goiter. Базовые параметры: 18 лет — 90 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
- Бельгия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
Literature regarding effects of goiter on the occurrence of obstructive sleep apnea (OSA) remains scarce. Reports have described cases of OSA in patients suffering from goiters, resolved after thyroidectomy. It has been recently shown that goiters of a total volume exceeding 25 mL leads to \>30% tracheal compression. The aims of the present study is to assess 1) the prevalence of OSA in patients suffering from goiters and planned for thyroidectomy 2) the role of thyroidectomy in OSA resolution in patients suffering from pre-operative OSA 3) the identification of predictors for persisting OSA.
Подробное описание
Introduction
Literature regarding effects of goiter on the occurrence of obstructive sleep apnea (OSA) remains scarce. Reports have described cases of OSA in patients suffering from goiters, resolved after thyroidectomy.
It has been recently shown that goiters of a total volume exceeding 25 mL leads to \>30% tracheal compression.
The aims of the present study is to assess 1) the prevalence of OSA in patients suffering from goiters and planned for partial/total thyroidectomy 2) the role of thyroidectomy in OSA resolution in patients suffering from pre-operative OSA 3) the identification of predictors for persisting OSA.
Methods
Design Prospective study Settings Tertiary referral center, university hospital Patients Patients referred for partial/total thyroidectomy for goiter Baseline assessment All patients planned for thyroidectomy will be prospectively included. Exclusion criteria will be: previous cervical surgery/radiotherapy, language barrier, chest disease known to narrow upper airways.
Patient will be assessed by home Polysomnography(PSG), one night, Pulmonary function tests, including respiratory muscle strength, and comprehensive biological assessment of thyroid function.
Follow up Three months after thyroidectomy, the same assessment will be repeated.
Statistical analysis
Statistical analysis will be performed to determine the percentage of patients suffering from OSA before surgery (apnea-hypopnea index (AHI) \>5/hour of sleep on PSG). As the aim of the present study is to assess the role of thyroidectomy in OSA resolution, we will compare pre- and post-thyroidectomy PSG results in patients exhibiting AHI \>5/hour of sleep (chi square test). OSA resolution will be defined as decrease in AHI \> 50 % or reduction of AHI \<5hour of sleep. As one of the secondary aim is the identification of predictors for persisting OSA, multivariate analysis will be performed to assess factors of persisting OSA, among age, neck circumference, body mass index, sex, pre/post menopausal status and pulmonary function tests parameters.
Вмешательства
- Диагностический тест polysomnography
Patient will be assessed by home Polysomnography(PSG), one night, Pulmonary function tests, including respiratory muscle strength, and comprehensive biological assessment of thyroid function.
Первичные конечные точки
- the prevalence of obstructive sleep apnea in patients suffering from goiters and planned for partial/total thyroidectomy [Срок оценки: one month]
Вторичные конечные точки (2)
- OSA resolution after thyroidectomy in patients suffering from pre-operative OSA [Срок оценки: three months after surgery]
- body mass index is increased in patients with persisting OSA after surgery [Срок оценки: three months after surgery]
Критерии участия
Критерии включения
°patients planned for thyroidectomy for goiter
Критерии исключения
- previous cervical surgery/radiotherapy
- language barrier
- chest disease known to narrow upper airways
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Бельгия · 1 центр
- CHU Saint Pierre — Brussels
Идентификаторы
NCT: NCT05391945 · THYR_MB/AR/KP_2022