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临床试验/NCT02001792
NCT02001792已完成不适用

Patient Positioning During Colonoscopy: Effects on Safety and Diagnostic Outcome

Technical University of Munich3 个研究点 分布在 1 个国家目标入组 412 人开始时间: 2012年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
412
试验地点
3
主要终点
frequency of breathing and cardiac problems (decrease of saturation, hypotension, bradycardia) during colonoscopy

研究概览

简要总结

The purpose of this study is to determine the effects of patient positioning during colonoscopy on patient safety and diagnostic outcome.

详细描述

Sedative drugs are widely-used during endoscopic procedures. The administration of these drugs contain the potential hazard of breathing and cardiac complications. Moreover it is well-known that the dorsal position is in some ways associated to breathing problems while patients are asleep. We assume this also to be true related to short anesthesia during colonoscopy. Patient positioning may therefore have a positive effect on the safety during colonoscopy by reducing the absolute time that sedated patients spend in a supine position. We compiled a randomized trial which compares the appearance of breathing and cardiovascular complications by performing colonoscopy either in a dorsal or in a left lateral position.

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
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • colonoscopy indicated

排除标准

  • patient denies sedation
  • prior saturation < 90%
  • prior heart rate < 50 bpm
  • prior blood pressure < 90 mmHg

结局指标

主要结局

frequency of breathing and cardiac problems (decrease of saturation, hypotension, bradycardia) during colonoscopy

时间窗: participants will be followed for the duration of colonoscopy during hospital stay an expected average of 1 hour

saturation and heart rate will be measured continuously, blood pressure will be measures all 3 minutes

次要结局

  • Adenoma detection rate(1 day)

研究者

发起方
Technical University of Munich
申办方类型
Other
责任方
Sponsor

研究点 (3)

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