Biopotentials for Clinician Satisfaction With Sedation in Colonoscopy

University of Ulm112 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

112

Conditions

Bowel Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: 1 day

Secondary Outcomes

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

Time frame: 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.

Time frame: 1 day

Correlation between clinician satisfaction with sedation (CSSI) and resected polyp count

Time frame: 1 day

Correlation between clinician satisfaction with sedation (CSSI) and total polyp resection time

Time frame: 1 day

Correlation between clinician satisfaction with sedation (CSSI) and time to reach caecum

Time frame: 1 day

Correlation between clinician satisfaction with sedation (CSSI) and years of experience of assisting nurse

Time frame: 1 day