COMBO Endoscopy Oropharyngeal Airway in Sedated Endoscopic Retrograde Cholangiopancreatography for Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The incidence of hypoxia
研究概览
简要总结
Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) 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 this study is to assess the efficacy of the COMBO Endoscopy Oropharyngeal Airway in reducing the incidence of hypoxia in patients undergoing ERCP under sedation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years；
- •The ASA classification ranges from I to III.
- •Patients have signed the informed consent form.
- •Patients scheduled to undergo sedated ERCP examination;
- •The estimated duration of the procedure does not exceed 45 minutes.
排除标准
- •Patients with coagulation disorders, tendency for oral/nasal bleeding, mucosal injury/occupying lesions, or difficult oropharyngeal airway insertion making airway management unfeasible;
- •Severe cardiac dysfunction (<4 METs);
- •Severe renal insufficiency (requiring preoperative dialysis);
- •Child-Pugh class C;
- •Diagnosed chronic obstructive pulmonary disease (COPD) or other acute/chronic pulmonary diseases requiring long-term/intermittent oxygen therapy;
- •Increased intracranial pressure;
- •Upper respiratory tract infections (oral/nasal/pharyngeal);
- •Fever (core temperature >37.5°C);
- •Confirmed pregnancy or current breastfeeding;
- •Allergy to sedatives (e.g., propofol) or medical adhesives;
- •Emergency procedures;
- •Multiple trauma injuries;
- •Peripheral oxygen saturation (SpO2) levels below 95% while breathing room air preoperatively;
- •BMI <18.5 or >30 kg/m²;
- •Current participation in other clinical trials;
- •Other conditions deemed ineligible by investigators.
结局指标
主要结局
The incidence of hypoxia
时间窗: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
75% ≤ SpO2 \< 90% for \<60 s
次要结局
- The incidence of sub-clinical respiratory depression(Patients will be followed for the duration of hospital stay, an expected average about 2 hours)
- The incidence of severe hypoxia(Patients will be followed for the duration of hospital stay, an expected average about 2 hours)
研究者
Diansan Su
Chair of the Department of Anesthesiology
Zhejiang University