Supraglottic Oxygenation Via Oral Transtracheal Catheter for Reducing the Incidence of Hypoxemia During ERCP Under Sedation：a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 410
- 试验地点
- 3
- 主要终点
- The incidence of hypoxia
研究概览
简要总结
Endoscopic retrograde cholangiopancreatography (ERCP) is commonly used for the diagnosis and treatment of pancreatobiliary diseases. While Monitored Anesthesia Care (MAC) enhances the efficiency of ERCP, deep sedation introduces significant airway risks, particularly hypoxemia resulting from sedative-induced upper airway collapse. With reported hypoxemia rates ranging from 10% to 69%, and the potential for severe complications such as myocardial ischemia and neurological damage, effective airway management is paramount. Supraglottic oxygenation via oral transtracheal catheter provides a viable method for relieving obstruction and enabling positive pressure ventilation, serving as a less invasive alternative to tracheal intubation. Despite its proven utility in other settings, this technique has not yet been evaluated in the context of deeply sedated ERCP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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≥18years
- •The ASA classification ranges from I to III
- •Patients have signed the informed consent form
- •Patients scheduled to undergo sedated ERCP examination procedure
排除标准
- •Severe cardiac dysfunction (<4 METs);
- •Diagnosed chronic obstructive pulmonary disease (COPD) or other acute/chronic pulmonary diseases requiring long-term/intermittent oxygen therapy;
- •Upper respiratory tract infections including oral, nasal or pharyngeal infections;
- •Fever (core temperature >37.5°C);
- •Confirmed pregnancy or current breastfeeding;
- •Hypersensitivity to sedative drugs such as propofol;
- •Current participation in other clinical trials;
研究组 & 干预措施
The Supraglottic Oxygenation Via Oral Transtracheal Catheter Group
In this group, patients received supraglottic oxygenation via an oral transtracheal catheter
干预措施: The Supraglottic Oxygenation Via Oral Transtracheal Catheter Group (Device)
The Regular Nasal Cannula Group
In this group, patients received oxygenation via the regular nasal cannula
干预措施: The Regular Nasal Cannula (Device)
结局指标
主要结局
The incidence of hypoxia
时间窗: Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit)
75%≤SpO2\<90%for\<60s
次要结局
- The incidence of sub-clinical respiratory depression(Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit))
- The incidence of severe hypoxia(Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit))
研究者
Diansan Su
Chairman of Anesthesiology
Zhejiang University