Patient Positioning and Airway Management During Endoscopic Retrograde Cholangiopancreatography ERCP and the Effect on Airway Complications and Procedure Outcomes in Patients With Risks for Anesthesia Adverse Events
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Incidence of sedation related adverse events or the need for airway maneuvers
研究概览
简要总结
The aim of this study is to determine the effect of airway management (a set of medical procedures performed to prevent airway blockage and thus ensure an open path between a patient's lungs and the atmosphere) during endoscopic retrograde cholangiopancreatography [(ERCP), a procedure commonly used to treat conditions of the bile ducts and pancreas] and the effect on airway complications (problems), time to biliary cannulation (access into bile duct) and total procedure duration (length of time). Two methods are being compared and studied: 1) general endotracheal anesthesia: an inhalation anesthetic (substance that blocks pain) technique in which anesthetic and respiratory gases pass through a tube placed in the trachea (throat) via the mouth or nose vs 2) deep sedation without endotracheal intubation: local anesthesia together with sedation (drug that produces sleep) and analgesia (drug that treats pain) only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Patient undergoing ERCP without preceding endoscopic ultrasound (EUS)
- •At least one of the following risk factors for adverse events during sedation:
- •STOP-BANG score of 3 or higher
- •Abdominal ascites on either physical exam or imaging within the last 14 days
- •BMI greater than or equal to 35
- •Chronic lung disease
- •ASA class 4
- •Mallampati Class 4 airway (only hard palate visible)
- •Concurrent moderate to heavy alcohol use (≥4 drinks/day for men and ≥3 drinks/day for women)
排除标准
- •EUS preceding the ERCP
- •Emergent indication for ERCP (eg cholangitis with septic shock)
- •Presence of a tracheostomy
- •Unstable airway
- •Gastric outlet obstruction
- •Altered foregut anatomy (eg Roux-en-Y gastric bypass, Billroth II)
- •Inability to give informed consent
研究组 & 干预措施
general endotracheal anesthesia
an inhalation anesthetic (substance that blocks pain) technique in which anesthetic and respiratory gases pass through a tube placed in the trachea (throat) via the mouth or nose
干预措施: general endotracheal anesthesia (Other)
deep sedation without endotracheal intubation
local anesthesia together with sedation (drug that produces sleep) and analgesia (drug that treats pain) only.
干预措施: deep sedation without endotracheal intubation (Other)
结局指标
主要结局
Incidence of sedation related adverse events or the need for airway maneuvers
时间窗: approximately one year
次要结局
- Procedure duration(intraoperative)
- Time to cannulation of intended duct system(during the procedure)
- Technical success of ERCP(approximately one year)
- Immediate ERCP adverse events(Adverse events within 24 hours of ERCP)
- Delayed adverse events(Adverse events occurring within 7 days)