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Biopotentials for Clinician Satisfaction With Sedation in Colonoscopy (BCSSC)

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ClinicalTrials.gov Identifier: NCT03860779
Recruitment Status : Recruiting
First Posted : March 4, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Alexander Hann, 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.

Condition or disease
Bowel Disease

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biopotentials for Clinician Satisfaction With Sedation in Colonoscopy
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy




Primary Outcome Measures :
  1. Correlation between clinician satisfaction with sedation and pain experienced during colonoscopy [ Time Frame: 1 day ]
    Correlation between Clinician Satisfaction with Sedation Instrument (CSSI) and observer reported pain (movements and paralinguistic sounds) during sedation

  2. Prediction of observer reported pain by biopotential feature pattern [ Time Frame: 1 day ]
    Prediction of observer reported pain events (movements and paralinguistic sounds) by biopotential feature pattern.


Secondary Outcome Measures :
  1. Correlation between clinician satisfaction with sedation (CSSI) and sedation depth [ Time Frame: 1 day ]
    Correlation between clinician satisfaction with sedation (CSSI) and sedation depth measured by Modified Observer's assessment of Alertness/Sedation Score

  2. Correlation between clinician satisfaction with sedation (CSSI) and frequency of sedation use [ Time Frame: 1 day ]
    Correlation between clinician satisfaction with sedation (CSSI) and frequency of sedation use measured in relation to total examination duration.

  3. Correlation between clinician satisfaction with sedation (CSSI) and resected polyp count [ Time Frame: 1 day ]
    Correlation between clinician satisfaction with sedation (CSSI) and resected polyp count

  4. Correlation between clinician satisfaction with sedation (CSSI) and total polyp resection time [ Time Frame: 1 day ]
    Correlation between clinician satisfaction with sedation (CSSI) and total polyp resection time

  5. Correlation between clinician satisfaction with sedation (CSSI) and time to reach caecum [ Time Frame: 1 day ]
    Correlation between clinician satisfaction with sedation (CSSI) and time to reach caecum

  6. Correlation between clinician satisfaction with sedation (CSSI) and years of experience of assisting nurse [ Time Frame: 1 day ]
    Correlation between clinician satisfaction with sedation (CSSI) and years of experience of assisting nurse



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients scheduled at the University Hospital for a colonoscopy using propofol sedation.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03860779


Contacts
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Contact: Alexander Hann +49 731 500 ext 44750 Alexander.Hann@uniklinik-ulm.de
Contact: Steffen Walter +49 731 500 ext 61910 steffen.walter@uni-ulm.de

Locations
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Germany
University Ulm Recruiting
Ulm, Germany, 89081
Contact: Alexander Hann    0049731500 ext 44750    Alexander.Hann@uniklinik-ulm.de   
Sponsors and Collaborators
University of Ulm
Investigators
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Principal Investigator: Alexander Hann University Ulm

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Responsible Party: Alexander Hann, Senior Gastroenterologist, Department of Gastroenterology, University of Ulm
ClinicalTrials.gov Identifier: NCT03860779     History of Changes
Other Study ID Numbers: BCSSC
First Posted: March 4, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alexander Hann, University of Ulm:
colonoscopy
biosignals
pain
sedation