NCT00685386已完成不适用
A Randomized, Controlled, Double-blind Trial of CO2 Versus Air Insufflation During Endoscopic Retrograde Cholangiopancreatography
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Abdominal pain (VAS).
研究概览
简要总结
The purpose of this study it to conduct a randomized, controlled, double-blinded trial of carbon dioxide (CO2) versus air insufflation during endoscopic retrograde cholangiopancreatography (ERCP).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •referred for ERCP for any indication at UNC Hospitals
排除标准
- •age < 18 years
- •COPD requiring oxygen or with known CO2 retention
- •any medical condition with known CO2 retention
- •medical instability making the procedure unsafe
- •absolute requirement for same-day second endoscopy
- •ERCP performed in the OR or under GA
- •inability to read or understand English
- •use of chronic opiates for pain
- •pregnant women
研究组 & 干预措施
I
Experimental
干预措施: CO2 insufflation (Other)
II
Placebo Comparator
Room air will be used for insufflation as the placebo comparator arm.
干预措施: Room air insufflation (Other)
结局指标
主要结局
Abdominal pain (VAS).
时间窗: pre-procedure and up to 24 hours post-procedure.
次要结局
- The extent of CO2 retention.(Intra-procedure)
研究者
研究点 (1)
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