High-Flow Nasal Cannula for Preventing Hypoxia During Sedated Endoscopy in High-Risk Obstructive Sleep Apnea Patients

Официальное название

High-Flow Nasal Cannula for Preventing Hypoxia During Sedated Endoscopy in High-Risk Obstructive Sleep Apnea Patients: A Multicenter Randomized Trial

Обзор

Hypoxia represents the most frequent adverse event during propofol-sedated gastrointestinal endoscopy. The STOP-BANG questionnaire serves as a widely adopted, straightforward tool for screening obstructive sleep apnea (OSA) risk, with a score ≥5 identifying high-risk OSA patients who are particularly susceptible to hypoxia under sedation. Although preliminary research from our team suggests that High-Flow Nasal Cannula (HFNC) may lower the incidence of hypoxemia, evidence remains limited and inconsistent in studies specifically targeting high-risk OSA populations. Therefore, this multicenter randomized controlled trial aims to evaluate whether HFNC can effectively reduce the occurrence of hypoxia during sedated gastrointestinal endoscopy in patients identified as high-risk for OSA.

Вмешательства

• Устройство High-flow nasal cannula Group
  Using High-flow nasal cannula oxygenation
• Устройство Regular Nasal Cannula
  Using regular nasal cannula for oxygenation

Первичные конечные точки

• The 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)

• The incidence of sub-clinical respiratory depression [Срок оценки: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]
• The incidence of severe hypoxia [Срок оценки: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]

Критерии участия

Критерии включения

• Age ≥18 years.
• STOP-Bang score ≥5.
• Scheduled for sedated gastrointestinal endoscopy (gastroscopy, colonoscopy, or combined gastroscopy + colonoscopy).
• The estimated duration of the procedure does not exceed 45 minutes.
• Patients have signed the informed consent form.

Критерии исключения

• Coagulation disorders or bleeding tendency (e.g., oral/nasal bleeding risk, mucosal injury, space-occupying obstructions).
• Active upper respiratory tract infection (oral, nasal, or pharyngeal), or fever (core temperature >37.5°C).
• Chronic obstructive pulmonary disease or other acute/chronic pulmonary diseases requiring long-term or intermittent oxygen therapy, or preoperative SpO₂ ≤ 92% on room air.
• Severe organ dysfunction, including: Cardiac insufficiency (<4 METs), Severe renal insufficiency (requiring dialysis), Diagnosed severe hepatic insufficiency, Increased intracranial pressure, ASA physical status ≥ IV.
• Confirmed pregnancy or current breastfeeding.
• Known allergy to sedatives (e.g., propofol) or medical adhesives.
• Multiple traumatic injuries.
• Current participation in another clinical trial.
• Other conditions deemed unsuitable by the investigator

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

• The First Affiliated Hospital, Zhejiang University School of Medicine — Ханчжоу
• The First Hospital Of Jiaxing — Jiaxing
• Quzhou People's Hospital — Quzhou

Публикации

• Xu M, Xiang S, Pi Y, Zhu Y, Chen X, Yang Q, Wu H, Deng K, Yin Y, Su D. High-flow nasal cannula oxygenation in sedated endoscopy for high-risk obstructive sleep apnea patients: study protocol for a multicentre randomised controlled trial. Ann Med. 2026 Dec;58(1):2704998. doi: 10.1080/07853890.2026.2704998. Epub 2026 Jul 27. PMID 42504139

Идентификаторы

NCT: NCT07307560 · ZJU2025C207

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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