Clinical trial NCT03860779: Biopotentials for Clinician Satisfaction With Sedation in Colonoscopy
Official title: Biopotentials for Clinician Satisfaction With Sedation in Colonoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bowel Disease
Keywords: colonoscopy
biosignals
pain
sedation
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2019-03-04
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled at the University Hospital for a colonoscopy using propofol sedation.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Correlation between clinician satisfaction with sedation and pain experienced during colonoscopy
timeFrame: 1 day
measure: Prediction of observer reported pain by biopotential feature pattern
timeFrame: 1 day
Secondary outcomes:
measure: Correlation between clinician satisfaction with sedation (CSSI) and sedation depth
timeFrame: 1 day
measure: Correlation between clinician satisfaction with sedation (CSSI) and frequency of sedation use
timeFrame: 1 day
measure: Correlation between clinician satisfaction with sedation (CSSI) and resected polyp count
timeFrame: 1 day
measure: Correlation between clinician satisfaction with sedation (CSSI) and total polyp resection time
timeFrame: 1 day
measure: Correlation between clinician satisfaction with sedation (CSSI) and time to reach caecum
timeFrame: 1 day
measure: Correlation between clinician satisfaction with sedation (CSSI) and years of experience of assisting nurse
timeFrame: 1 day
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: University Ulm
Study officials:
affiliation: University Ulm
name: Alexander Hann
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hann A, Gruss S, Goetze S, Mehlhase N, Frisch S, Walter B, Walter S. Autonomous Nervous Response During Sedation in Colonoscopy and the Relationship With Clinician Satisfaction. Front Med (Lausanne). 2021 Jun 16;8:643158. doi: 10.3389/fmed.2021.643158. eCollection 2021.