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Идёт набор NCT07252102

Effect of HFNC on Incidence of Hypoxia During Sedated Gastrointestinal Endoscopy in Critical Patients

Без фазы С лечением Liver Cirrhosis Polyps of Colon Gastrointestinal Dysfunction

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 catheter oxygen, regular nasal catheter oxygen.
Кому может быть актуально
Состояния в реестре: Liver Cirrhosis, Polyps of Colon, Gastrointestinal Dysfunction. Базовые параметры: 18 лет — 80 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
Китай
Следующий шаг
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Официальное название

Effect of High Flow Nasal Cannula Oxygenation on Incidence of Hypoxia During Sedated Gastrointestinal Endoscopy in Critical Patients: A Multicentre Randomised Controlled Trial

Обзор

High flow nasal cannula oxygenation (HFNC) offers high flow and concentration oxygen delivery, providing excellent non-respiratory oxygenation. As a relatively new oxygen delivery method, it has gained widespread use. We have demonstrated that high flow nasal cannula oxygenation reduce the incidence of hypoxia during sedated gastrointestinal endoscopy in patients with American Anesthesiologist Rating (ASA rating) grades 1 to 2 and obesity. We hypothesized that HFNC could mitigate the risk of hypoxia in critical patients during sedated gastrointestinal endoscopy. To confirm this, we selected critical patients with ASA grades 3 to 4 who were scheduled for gastrointestinal endoscopy. We observed and compared the incidence of hypoxia (75%≤SpO2 \< 90% and \< 60S), severe hypoxia (SpO2\<75% for any duration or 75%≤SpO2 \< 90%, ≥60s), subclinical respiratory depression (90%≤SpO2 \< 95%), respiratory-related adverse events, sedation-related adverse events, and complications associated with high flow nasal cannula oxygenation using HFNC or regular nasal cannula during the sedated gastrointestinal endoscopy.

Вмешательства

  • Устройство High-flow nasal catheter oxygen
    Before induction of anesthesia, connect the Airvo2 (HFNC high flow device) special nasal cannula to inhale oxygen, and preoxygenate with an oxygen flow rate of 6L /min. After induction of anesthesia, adjust the oxygen flow rate to 60L /min, oxygen concentration 100%, oxygen temperature 37℃ until the end of gastrointestinal endoscopy.
  • Устройство regular nasal catheter oxygen
    Before anesthesia induction, a disposable nasal catheter oxygen inhalation device (covered by HFNC nasal catheter and blinded to the patient) was connected to an oxygen source for pre-oxygen inhalation, 6L/min. After induction of anesthesia, oxygen was continued for 6L/min until the end of gastroenteroscopy.

Первичные конечные точки

  • Incidence of hypoxia [Срок оценки: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]
Вторичные конечные точки (2)
  • Incidence of severe hypoxia [Срок оценки: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]
  • Incidence of subclinical respiratory depression [Срок оценки: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]

Критерии участия

Критерии включения

  • 18≤ age ≤80, gender is not limited;
  • Patients undergoing elective gastroenteroscopy or treatment;
  • ASA grade Ⅲ\~Ⅳ;
  • 18 kg/m2≤BMI≤28kg/m2;
  • The operation time of gastroenteroscopy is expected to be no more than 60min;
  • Clearly understand, voluntarily participate in the study, and have informed consent from myself or my family members.

Критерии исключения

  • Patients with nasal congestion, nasal bleeding, recent nasal trauma, recent nasal surgery, increased intracranial pressure and skull fracture, etc., who can not perform high-flow nasal catheter oxygen;
  • acute respiratory infections and asthma attacks;
  • Patients diagnosed with COPD;
  • Clear difficult airway;
  • Acute upper gastrointestinal bleeding with shock;
  • Gastrointestinal obstruction with gastric content retention;
  • Allergic to sedatives such as propofol;
  • Persons with no capacity for civil conduct such as cognitive dysfunction.

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
Простое слепое
Основная цель
Профилактика

Центры проведения

Китай · 3 центра
  • Shenzhen Hospital of Southern Medical University — Шэньчжэнь
  • Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center — Шэньчжэнь
  • The First Affiliated Hospital, Zhejiang University School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT07252102 · ZJU2025C036

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗