跳至主要内容
临床试验/NCT00685386
NCT00685386已完成不适用

A Randomized, Controlled, Double-blind Trial of CO2 Versus Air Insufflation During Endoscopic Retrograde Cholangiopancreatography

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2008年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
74
试验地点
2
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

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

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

申办方类型
Other

研究点 (2)

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