Меню
Идёт набор NCT06438302

Effects of Nasal Ventilation on Cerebral and Pulmonary Function in Orally Intubated Patients

— Наблюдательное Hypoxemic Acute Respiratory Failure

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: EEG activity measurement.
Кому может быть актуально
Состояния в реестре: Hypoxemic Acute Respiratory Failure. 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 cavity generates rhythmic oscillations transmitted by the olfactory bulb to the brain, which induces cerebral activation in functional areas and is associated with better cognitive performance compared to oral breathing. Consequently, the abolition of nasal ventilation in patients intubated via the orotracheal route could have deleterious effects on brain activity. Besides the loss of olfaction, the abolition of nasal ventilation could affect brain activity and respiratory control, consequently altering regional pulmonary ventilation. The hypothesis of the study is that nasal ventilation through the passage of humidified nasal airflow in patients intubated via the orotracheal route would be associated with modulation of cerebral electrical activity and tissue oxygenation and a modification of regional pulmonary ventilation.

Подробное описание

The effects of nasal ventilation on cerebral activity will be studied on orally intubated and sedated patients in six experimental conditions. The first condition consists of nociceptive stimulation of the left upper limb as a negative control. In three conditions, the inspired fraction of oxygen (FiO2) will remain at 21% while applying three different rates of humidified nasal air at 0L/min, 30L/min and 60L/min respectively. The last two conditions consist of applying humidified nasal air at 30L/min and 60L/min with a FiO2 of 100%. The primary objective of this study is to evaluate the effects of high-flow humidified nasal air on electroencephalogram activity (root mean square gamma frequency) in sedated, orally intubated patients. The secondary objectives of the study are to evaluate the effects of high-flow humidified nasal air on cerebral perfusion and oxygenation, gas exchange and regional pulmonary ventilation in the same patients.

Вмешательства

  • Устройство EEG activity measurement
    The nasal ventilation device (placed as part of the research) (AIRVO 2; Fisher and Paykel Healthcare, Auckland, New Zealand) will be positioned via nasal cannulas adapted to the patient's anatomy. The FiO2 will be set at 21% and the flow rate will be fixed at 0 L/min at the inclusion visit. The temperature of the humidified nasal oxygenator will be set at 31°C. Six 30-minute experimental conditions will be performed successively: 1) 0 L/min flow, FiO2 21%, 2) 30 L/min flow, FiO2 21%, 3) 30 L/mi

Первичные конечные точки

  • Study the effects of nasal ventilation on brain electrical activity using electroencephalogram recording (EEG) in sedated orotracheally intubated patients. [Срок оценки: At inclusion (day 1) - step 1 to 6]
Вторичные конечные точки (6)
  • Study the effects of nasal ventilation on cerebral perfusion [Срок оценки: At inclusion (day 1) - step 1 to 6]
  • Study the effects of nasal ventilation on cerebral tissue oxygenation [Срок оценки: At inclusion (day 1) - step 1 to 6]
  • Study the effects of nasal ventilation on gas exchange [Срок оценки: At inclusion (day 1) - step 1 to 6]
  • Study the effects of nasal ventilation on gas exchange [Срок оценки: At inclusion (day 1) - step 1 to 6]
  • Study the effects of nasal ventilation on regional lung ventilation distribution [Срок оценки: At inclusion (day 1) - step 1 to 6]
  • Study the effects of nasal ventilation on regional lung ventilation distribution [Срок оценки: At inclusion (day 1) - step 1 to 6]

Критерии участия

Критерии включения

  • Age ≥ 18 years old
  • Hypoxemic acute respiratory failure
  • Intubation and mechanical ventilation since less than 4 days
  • PaO2/FiO2 ratio less than 200
  • RASS<-4
  • Consent obtained from next of kin
  • Patient with health insurance

Критерии исключения

  • Central nervous system diseases (stroke, MS, epilepsy)
  • Psychiatric illnesses (psychosis, depression) (indicated on patient's medical record)
  • Hemodynamic instability (noradrenalin>2mg/h)
  • Patient on AME
  • Patients under legal protection (guardianship/curators)
  • Pregnant or breast-feeding women

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
  • Service de Médecine Intensive Réanimation - Hôpital Pitié -Salpêtrière — Paris

Идентификаторы

NCT: NCT06438302 · APHP240271

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗