Biopotentials for Clinician Satisfaction With Sedation in Colonoscopy

Bowel Disease Clinical Trial

— BCSSC  

Official title:

Biopotentials for Clinician Satisfaction With Sedation in Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03860779
• Other study ID #: BCSSC
• Status: Completed
• Start date: March 4, 2019
• Est. completion date: July 1, 2019

Study information

• Verified date: May 2020
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age above 18

• ASA classification I to II

• Indication for colonoscopy with propofol sedation

• Written informed consent

Exclusion Criteria:

• Pregnancy

Related Conditions & MeSH terms

• Bowel Disease
• Intestinal Diseases

Locations

Country	Name	City	State
Germany	University Ulm	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Correlation between clinician satisfaction with sedation (CSSI) and resected polyp count	Correlation between clinician satisfaction with sedation (CSSI) and resected polyp count	1 day
Secondary	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
Secondary	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
Secondary	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