The Efficacy and Safety of the COMBO Endoscopy Oropharyngeal Airway in Gastrointestinal Endoscopy Procedure

Официальное название

The Efficacy and Safety of the COMBO Endoscopy Oropharyngeal Airway Reduce the Incidence of Hypoxia in Patients Undergoing Gastrointestinal Endoscopy Sedated With Propofol.

Обзор

Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing gastrointestinal endoscopy with propofol. 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. This device has been purposefully designed to cater to the unique requirements of endoscopic procedures. The principal objective of our randomized study is to assess the efficacy and safety of the COMBO Endoscopy Oropharyngeal Airway reduce the incidence of hypoxia on patients undergoing gastrointestinal endoscopy under propofol sedation.

Вмешательства

• Устройство the COMBO Endoscopy Oropharyngeal Airway
  Using the COMBO Endoscopy Oropharyngeal Airway for 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≤ Age ≤60.
• Patients undergoing gastroendoscopy and/or colonoscopy procedure.
• Patients have signed the informed consent form.
• The ASA classification ranges from I to II.
• The estimated duration of the procedure does not exceed 45 minutes.

Критерии исключения

• Patients who exhibit contraindications to oropharyngeal airway ventilation, such as coagulation disorders, a predisposition to oral and nasal bleeding, mucosal damage, or anatomical constraints impeding oropharyngeal channel placement.
• Severe cardiac insufficiency, defined as a maximal exercise capacity of less than 4 metabolic equivalents (METs).
• Profound renal insufficiency necessitating preoperative dialysis.
• A confirmed severe liver dysfunction.
• Patients diagnosed with chronic obstructive pulmonary disease (COPD) or those presently experiencing other acute and chronic pulmonary conditions necessitating prolonged or intermittent oxygen therapy.
• Elevated intracranial pressure.
• Upper respiratory tract infections, encompassing the oral, nasal, and pharyngeal regions.
• Fever, defined as a core body temperature exceeding 37.5 degrees Celsius.
• Pregnancy or lactation.
• Hypersensitivity reactions to sedatives like propofol or medical equipment such as adhesive tape.
• Urgent surgical intervention.
• Polytrauma.
• Peripheral oxygen saturation (SpO2) levels below 95% while breathing room air preoperatively.
• BMI<18.5 or BMI>30.
• Patients with a documented history of substance abuse, specifically drugs and/or alcohol, within the two years preceding the commencement of the screening period. Substance abuse in this context is defined as consuming more than three standard alcoholic beverages daily, roughly equivalent to 10g of alcohol or 50g of Chinese Baijiu.
• Patients with a history of mental and neurological disorders, including but not limited to depression, severe central nervous system depression, Parkinson's disease, basal ganglia lesions, schizophrenia, epilepsy, Alzheimer's disease, and myasthenia gravis.
• Presently engaged in concurrent participation in additional clinical trials.
• Patients considered ineligible by researchers for inclusion in this clinical trial.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 10 центров

• The First Affiliated Hospital with Nanjing Medical University — Нанкин
• The First Affiliated Hospital Of Nanchang University — Nanchang
• Shangdong Provincial Qianfoshan Hospital — Цзинань
• Fudan University Shanghai Cancer Center — Шанхай
• Renji Hospital — Шанхай
• Tongji Hospital Of Tongji University — Шанхай
• Xinhua Hospital Affliated To Shanghai Jiaotong University School Of Medicine — Шанхай
• The First Affliated Hospital of Xi'an Jiangtong University — Xi’an
• … и ещё 2 центра

Публикации

• Zhang Y, Shi M, Qu Y, Cheng X, Zhang J, Guo S, Zheng Y, Su D. Efficacy and safety of the COMBO endoscopy oropharyngeal airway in gastrointestinal endoscopy: a study protocol for a multicenter randomized controlled trial. Trials. 2025 Dec 13;27(1):51. doi: 10.1186/s13063-025-09351-2. PMID 41390738

Идентификаторы

NCT: NCT06081647 · LY2023-159-B

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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