Biopotentials for Clinician Satisfaction With Sedation in Colonoscopy
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
- 否
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
Alexander Hann
Senior Gastroenterologist, Department of Gastroenterology
University of Ulm
