Combination of COMBO Endoscopy Oropharyngeal Airway and HFNC Oxygenation in Sedated Gastrointestinal Endoscopy for Morbidly Obese Patients

Официальное название

Combination of COMBO Endoscopy Oropharyngeal Airway and High-flow Nasal Cannula Oxygenation in Sedated Gastrointestinal Endoscopy for Morbidly Obese Patients: a Multicenter, Randomized, Controlled Clinical Trial

Обзор

Hypoxaemia during sedated gastrointestinal endoscopy exceeds 40 % in morbidly obese (BMI ≥ 35 kg m-²) patients. High-flow nasal cannula alone often fails because of persistent airway collapse. A recent innovation in this domain is the COMBO Endoscopy Oropharyngeal Airway-a multifaceted device that encompasses capnography monitoring, bite block , oxygenation support, and oropharyngeal airway management.The purpose of this study is to investigate whether the combination of the COMBO Endoscopy Oropharyngeal Airway and High-Flow Nasal Cannula oxygenation reduces the incidence of hypoxemia in this population.

Вмешательства

• Устройство COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation
  Using the COMBO endoscopy oropharyngeal airway with High-Flow Nasal Cannula Oxygenation in sedated gastrointestinal endoscopy for morbidly obese patients
• Устройство High-Flow Nasal Cannula Oxygenation
  In this group, patients use high-flow nasal cannula oxygenation

Первичные конечные точки

• The incidence of hypoxemia [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 hypoxaemia [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.
• BMI ≥ 35 kg/m².
• Patients undergoing gastroscopy or gastrointestinal endoscopy.
• 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, oropharyngeal obstruction) making oropharyngeal airway placement unsafe or unfeasible.
• 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 · 5 центров

• Peking University First Hospital — Пекин
• Jinjiang Municipal Hospital — Jinjiang
• The First Affiliated Hospital, Zhejiang University School of Medicine — Ханчжоу
• The Fifth Affiliated Hospital of Wenzhou Medical University — Lishui
• Taizhou Hospital of Zhejiang Province — Taizhou

Идентификаторы

NCT: NCT07175155 · ZJU2025C140

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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