Biopotentials for Clinician Satisfaction With Sedation in Colonoscopy

Completed

• Conditions: Bowel Disease

• Registration Number: NCT03860779
• Lead Sponsor: University of Ulm

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-28
• Study First Submitted QC: 2019-02-28
• Study Start: 2019-03-04
• Study First Posted: 2019-03-04
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-09
• Last Update Posted: 2020-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

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

Exclusion Criteria

• Pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between clinician satisfaction with sedation and pain experienced during colonoscopy	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	1 day	Prediction of observer reported pain events (movements and paralinguistic sounds) by biopotential feature pattern.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Ulm; 🇩🇪 Ulm, Germany