Is the Gastro LMA a Feasible Alternative to the Use of a Native Airway for Endoscopic Retrograde Cholangiopancreatography (ERCP) Cases?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- The Number of Participants With Overall Success of ERCP With LMA Gastro
研究概览
简要总结
This trial determines the feasibility of Laryngeal Mask Airway Gastro (Laryngeal Mask Airway) when used on patients who are undergoing endoscopic retrograde cholangiopancreatography for pancreas and bile duct disorders. Laryngeal Mask Airway is a device that helps patients breathe while they are asleep during procedures.
详细描述
PRIMARY OBJECTIVES:
I. To determine the successful completion of endoscopic retrograde cholangiopancreatography (ERCP) with the Laryngeal Mask Airway (LMA) Gastro.
SECONDARY OBJECTIVES:
I. To determine gastroenterologist satisfaction with the LMA Gastro.
II. To determine anesthesia provider satisfaction with the LMA Gastro.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Adult patients undergoing elective ERCP with general anesthesia
排除标准
- •Patients with propofol allergy
- •Patients at increased aspiration risk
- •Patients with abnormal head/neck pathology preventing LMA Gastro placement
- •Patients with surgical or radiation treatment to the head/neck making LMA Gastro placement difficult
- •Esophagectomy patients
- •Patients already intubated upon arrival to endoscopy suite
- •Patients undergoing endoscopic ultrasound (EUS)
- •Patients with body mass index (BMI) 35 kg/m^2
- •Non-English speaking patients
研究组 & 干预措施
Device feasibility (Laryngeal Mask Airway, ERCP)
Patients wear Laryngeal Mask Airway after receiving general anesthesia and falling asleep. Patients then undergo standard of care endoscopic retrograde cholangiopancreatography. Patients also complete a 5-minute interview following ERCP procedure.
干预措施: Endoscopic Retrograde Cholangiopancreatography (Procedure)
Device feasibility (Laryngeal Mask Airway, ERCP)
Patients wear Laryngeal Mask Airway after receiving general anesthesia and falling asleep. Patients then undergo standard of care endoscopic retrograde cholangiopancreatography. Patients also complete a 5-minute interview following ERCP procedure.
干预措施: Interview (Other)
Device feasibility (Laryngeal Mask Airway, ERCP)
Patients wear Laryngeal Mask Airway after receiving general anesthesia and falling asleep. Patients then undergo standard of care endoscopic retrograde cholangiopancreatography. Patients also complete a 5-minute interview following ERCP procedure.
干预措施: Laryngeal Mask Airway (Device)
结局指标
主要结局
The Number of Participants With Overall Success of ERCP With LMA Gastro
时间窗: Up to 3 months
Successful completion of ERCP with the LMA® Gastro™
次要结局
未报告次要终点