Меню
Идёт набор NCT06547463

Effects of Nasal Airflow on Sleep in Tracheotomized Patients

— Наблюдательное Patients With Prolonged Weaning

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: nasal oxygenation device.
Кому может быть актуально
Состояния в реестре: Patients With Prolonged Weaning. 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

The passage of air through the nasal cavities generates rhythmic oscillations transmitted by the olfactory bulb to the brain, which induces cerebral activation in functional brain areas and is associated with better cognitive performance compared to oral breathing. Consequently, the abolition of nasal ventilation - intrinsic in tracheotomized and ventilated patients - could have deleterious effects on brain activity. Besides the loss of olfaction, the abolition of nasal ventilation could affect brain activity and sleep. The hypothesis of the present study is that the restoration of nasal stimulation by the passage of humidified nasal airflow in tracheotomized and ventilated patients improves sleep quality, notably with a greater proportion of time spent in REM sleep.

Подробное описание

The use of invasive mechanical ventilation via an endotracheal tube or tracheotomy involves bypassing the nasopharyngeal space and abolishing nasal ventilation. The first consequence is the loss of olfactory function. This function is quickly recovered when nasal ventilation is made possible. However, the abolition of nasal ventilation may have consequences beyond the loss of olfaction. The abolition of nasal ventilation in intubated rats inhibits these rhythmic oscillations, which can be restored by nasal sprays. In humans, nasal ventilation induces cerebral activity in functional brain areas and is associated with better cognitive performance compared to oral ventilation. In a model of intubated and ventilated rats, it has been shown that nasal sprays synchronized with the ventilator reduce hippocampal lesions compared to animals ventilated with an endotracheal tube without nasal sprays. Finally, in patients intubated with an endotracheal tube for toxic comas, the same nasal spray system restored brain activity and neural connectivity.

The aim of this study is to test the effects of nasal airflow of the sleep in tracheostomized patients who are still dependent to invasive mechanical ventilation. Patients will be investigated by a full polysomnography during two consecutive nights, with and without nasal airflow on the top of invasive mechanical ventilation, the two nights being randomized.

Вмешательства

  • Другое nasal oxygenation device
    Use of the nasal oxygenation device on one of the two nights during which polysomnography will be performed.

Первичные конечные точки

  • Effects of nasal ventilation on sleep quality in ventilation-dependent tracheostomized patients. [Срок оценки: During the 12 hours duration of PSG]
Вторичные конечные точки (6)
  • Effects of nasal ventilation on sleep duration [Срок оценки: During the 12 hours duration of PSG]
  • Effects of nasal ventilation on sleep architecture [Срок оценки: During the 12 hours duration of PSG]
  • Effects of nasal ventilation on the proportion of atypical sleep [Срок оценки: During the 12 hours duration of PSG]
  • Effects of nasal ventilation on minute ventilation [Срок оценки: During the 12 hours duration of PSG]
  • Effects of nasal ventilation on night-time awakenings [Срок оценки: During the 12 hours duration of PSG]
  • Effects of nasal ventilation on patient-ventilator asynchrony [Срок оценки: During the 12 hours duration of PSG]

Критерии участия

Критерии включения

  • Age ≥ 18 years
  • Admission to PRRS for weaning from ventilation
  • Tracheotomy and nocturnal invasive mechanical ventilation
  • Indication for polysomnography by care team
  • Agreement to participate by patient or trusted person/relative and signature of consent form
  • Affiliation with a social security scheme or beneficiary

Критерии исключения

  • Diseases of the central nervous system: cerebrovascular accident (CVA), multiple sclerosis (MS), epilepsy
  • Psychiatric illnesses (psychoses)
  • Hyperthermia (temperature > 38.5°C)
  • Agitation, resuscitation delirium
  • Continuous use of sedatives
  • Patients under legal protection (guardianship/curatorship)
  • Patients deprived of liberty by judicial or administrative decision
  • Patients under AME
  • Pregnant or breast-feeding women

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Pitié Salpétrière HOSPITAL — Paris

Идентификаторы

NCT: NCT06547463 · APHP240636

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗