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Идёт набор NCT07718295

HFNO Versus Face Mask for Cerebral Oxygenation During Procedural Sedation

Без фазы С лечением Procedural Sedation Hypoxemia Cerebral Oxygenation SEDLine

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: High-Flow Nasal Oxygen (HFNO), Conventional Face Mask Oxygen.
Кому может быть актуально
Состояния в реестре: Procedural Sedation, Hypoxemia, Cerebral Oxygenation, SEDLine. 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
Turkey (Türkiye)
Следующий шаг
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Официальное название

Effects of High-Flow Nasal Oxygen Versus Conventional Face Mask Oxygen on Cerebral Oxygenation During Out-of-Operating-Room Procedural Sedation: A Prospective Randomized Controlled Trial

Обзор

This prospective randomized controlled trial aims to compare the effects of high-flow nasal oxygen (HFNO) and conventional face mask oxygen therapy on cerebral oxygenation during procedural sedation performed outside the operating room. Adult patients undergoing elective diagnostic or interventional procedures under procedural sedation will be randomly assigned to receive either HFNO or conventional face mask oxygen. Regional cerebral oxygen saturation will be continuously monitored using near-infrared spectroscopy (NIRS), while sedation depth will be assessed using the Patient State Index (PSI, SedLine) and the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale. Secondary outcomes include peripheral oxygenation, ventilation parameters, arterial blood gas values, airway interventions, hemodynamic variables, and patient and practitioner satisfaction.

Вмешательства

  • Устройство High-Flow Nasal Oxygen (HFNO)
    Participants receive heated humidified high-flow nasal oxygen during procedural sedation.
  • Устройство Conventional Face Mask Oxygen
    Oxygen administered through a conventional face mask at 6 L/min with an approximate FiO₂ of 40%.

Первичные конечные точки

  • Change in Regional Cerebral Oxygen Saturation (ΔrSO₂) [Срок оценки: From initiation of procedural sedation until completion of the procedure (up to approximately 120 minutes).]
Вторичные конечные точки (12)
  • Peripheral Oxygen Saturation (SpO₂) [Срок оценки: From baseline to completion of procedural sedation (up to approximately 120 minutes).]
  • End-Tidal Carbon Dioxide (EtCO₂) [Срок оценки: Baseline and at completion of the procedure.]
  • Arterial Oxygen Tension (PaO₂) [Срок оценки: Before sedation and immediately after completion of the procedure.]
  • Arterial Carbon Dioxide Tension (PaCO₂) [Срок оценки: Before sedation and immediately after completion of the procedure.]
  • Incidence of Hypoxemia [Срок оценки: During procedural sedation (up to approximately 120 minutes).]
  • Number of Participants with a ≥20% Decrease in Regional Cerebral Oxygen Saturation (rSO₂) from Baseline [Срок оценки: During procedural sedation (up to approximately 120 minutes).]
  • Number of Participants Requiring Airway Intervention During Procedural Sedation [Срок оценки: During procedural sedation.]
  • Patient State Index (PSI) During Procedural Sedation [Срок оценки: Throughout procedural sedation until completion of the procedure.]
  • Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Score During Procedural Sedation [Срок оценки: Throughout procedural sedation until completion of the procedure.]
  • Heart Rate During Procedural Sedation [Срок оценки: From baseline until completion of the procedure.]
  • Mean Arterial Pressure During Procedural Sedation [Срок оценки: Throughout procedural sedation until completion of the procedure.]
  • Sedative Drug Consumption [Срок оценки: During procedural sedation.]

Критерии участия

Критерии включения

  • Age 18 years or older
  • American Society of Anesthesiologists physical status I-IV
  • Scheduled for an elective diagnostic or interventional procedure performed under procedural sedation in a non-operating-room setting
  • Ability to provide written informed consent
  • Willingness to participate in the study

Критерии исключения

  • Age younger than 18 years
  • Refusal or inability to provide written informed consent
  • Known neurological disorders
  • History of ischemic or hemorrhagic stroke
  • History of traumatic brain injury or previous cranial surgery
  • Peripheral arterial disease or systemic vasculitis
  • Advanced heart failure
  • Uncontrolled hypertension
  • Uncontrolled diabetes mellitus
  • Advanced chronic obstructive pulmonary disease (COPD)
  • Severe anemia (hemoglobin <8 g/dL)
  • Skin lesions or other conditions preventing proper placement of NIRS sensors
  • Nasal deformity or nasal obstruction preventing the use of high-flow nasal oxygen therapy
  • Any condition that, in the opinion of the investigators, could interfere with study participation or the interpretation of study results

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр
  • Fırat University Faculty of Medicine Hospital — Elâzığ

Идентификаторы

NCT: NCT07718295 · 47670

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗