Bowel DiseaseBCSSCNCT03860779
Biopotentials for Clinician Satisfaction With Sedation in Colonoscopy
An observational study of Bowel Disease, run by University of Ulm at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowel Disease
- How many people
- 112 participants
- Where
- 1 siteGermany
- Study dates
- 4 Mar 2019to 1 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled at the University Hospital for a colonoscopy using propofol sedation.
Who may be able to join
- Age above 18
- ASA classification I to II
- Indication for colonoscopy with propofol sedation
- Written informed consent
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Bowel Disease
- Keywords
- colonoscopy, biosignals, pain, sedation
- Medical subject headings
- Intestinal Diseases, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 1 day
Secondary outcomes (6)
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
Measured: 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.
Measured: 1 day
Correlation between clinician satisfaction with sedation (CSSI) and resected polyp count
Correlation between clinician satisfaction with sedation (CSSI) and resected polyp count
Measured: 1 day
Correlation between clinician satisfaction with sedation (CSSI) and total polyp resection time
Correlation between clinician satisfaction with sedation (CSSI) and total polyp resection time
Measured: 1 day
Correlation between clinician satisfaction with sedation (CSSI) and time to reach caecum
Correlation between clinician satisfaction with sedation (CSSI) and time to reach caecum
Measured: 1 day
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start4 Mar 2019
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bowel DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Hann, University of Ulm
- Investigators
- Alexander Hann, Principal investigator, University Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860779
- Sponsor's protocol ID
- BCSSC
- Acronym
- BCSSC
- Status last verified
- May 2020
- First submitted
- 28 Feb 2019
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34222272
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biopotentials for Clinician Satisfaction With Sedation in Colonoscopy
- ClinicalTrials.gov ID
- NCT03860779
- Acronym / sponsor ID
- BCSSC / BCSSC
- Conditions
- Bowel Disease
- Keywords
- colonoscopy, biosignals, pain, sedation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 4 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled at the University Hospital for a colonoscopy using propofol sedation.
Key inclusion criteria (4 listed)
- Age above 18
- ASA classification I to II
- Indication for colonoscopy with propofol sedation
- Written informed consent
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
6 secondary outcomes
Correlation between clinician satisfaction with sedation (CSSI) and sedation depth
Time frame: 1 day
Correlation between clinician satisfaction with sedation (CSSI) and frequency of sedation use
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Derived from this study: PubMed 34222272Hann 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Hann principal investigator
University Ulm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bowel Disease, run by University of Ulm at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between clinician satisfaction with sedation and pain experienced during colonoscopy (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03860779, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.