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临床试验/NCT03860779
NCT03860779已完成不适用

Biopotentials for Clinician Satisfaction With Sedation in Colonoscopy

University of Ulm1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2019年3月4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
112
试验地点
1
主要终点
Correlation between clinician satisfaction with sedation and pain experienced during colonoscopy

研究概览

简要总结

Nurse-administered propofol sedation has become the standard procedure for colonoscopy in Germany. Although patient satisfaction with this method is high, there is little data about the satisfaction of the examiner and factors that might negatively influence this satisfaction. Often due to the fact that the sedated patient usually expresses pain by movements of the body and paralinguistic sounds the examination has to pause until the next propofol bolus induces a deeper sedation. In order to measure the correlation of examiner satisfaction and negative factors the investigators initiated this prospective observational study. During this study examiner satisfaction and the correlation with observer reported pain (movements and paralinguistic sounds) will be measured. Additionally different biopotentials (electromyography, skin conductance level, body temperature, pulse) of the patient will be recorded during the examination and feature pattern will be correlated to the observer reported pain in order to detect pain before the expression of pain leads to a pause in the colonoscopy examination. Other factors that might influence examiner satisfaction, like duration to reach the caecum and duration of polypectomy will additionally be evaluated.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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 above 18
  • ASA classification I to II
  • Indication for colonoscopy with propofol sedation
  • Written informed consent

排除标准

  • Pregnancy

结局指标

主要结局

Correlation between clinician satisfaction with sedation and pain experienced during colonoscopy

时间窗: 1 day

Correlation between Clinician Satisfaction with Sedation Instrument (CSSI) and observer reported pain (movements and paralinguistic sounds) during sedation

Prediction of observer reported pain by biopotential feature pattern

时间窗: 1 day

Prediction of observer reported pain events (movements and paralinguistic sounds) by biopotential feature pattern.

次要结局

  • Correlation between clinician satisfaction with sedation (CSSI) and sedation depth(1 day)
  • Correlation between clinician satisfaction with sedation (CSSI) and time to reach caecum(1 day)
  • Correlation between clinician satisfaction with sedation (CSSI) and years of experience of assisting nurse(1 day)
  • Correlation between clinician satisfaction with sedation (CSSI) and frequency of sedation use(1 day)
  • Correlation between clinician satisfaction with sedation (CSSI) and resected polyp count(1 day)
  • Correlation between clinician satisfaction with sedation (CSSI) and total polyp resection time(1 day)

研究者

发起方
University of Ulm
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexander Hann

Senior Gastroenterologist, Department of Gastroenterology

University of Ulm

研究点 (1)

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