Biopotentials for Clinician Satisfaction With Sedation in Colonoscopy

Study Overview
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Brief Summary
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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.

Official Title
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Biopotentials for Clinician Satisfaction With Sedation in Colonoscopy

Conditions
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Bowel Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age above 18 ASA classification I to II Indication for colonoscopy with propofol sedation Written informed consent Exclusion Criteria: Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between clinician satisfaction with sedation and pain experienced during colonoscopy | Correlation between Clinician Satisfaction with Sedation Instrument (CSSI) and observer reported pain (movements and paralinguistic sounds) during sedation | 1 day | 
| Prediction of observer reported pain by biopotential feature pattern | Prediction of observer reported pain events (movements and paralinguistic sounds) by biopotential feature pattern. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between clinician satisfaction with sedation (CSSI) and sedation depth | Correlation between clinician satisfaction with sedation (CSSI) and sedation depth measured by Modified Observer's assessment of Alertness/Sedation Score | 1 day | 
| Correlation between clinician satisfaction with sedation (CSSI) and frequency of sedation use | Correlation between clinician satisfaction with sedation (CSSI) and frequency of sedation use measured in relation to total examination duration. | 1 day | 
| Correlation between clinician satisfaction with sedation (CSSI) and resected polyp count | 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 | Correlation between clinician satisfaction with sedation (CSSI) and total polyp resection time | 1 day | 
| Correlation between clinician satisfaction with sedation (CSSI) and time to reach caecum | 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 | Correlation between clinician satisfaction with sedation (CSSI) and years of experience of assisting nurse | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, biosignals, pain, sedation