## Protocol Section
### Identification Module
**NCT ID:** NCT03860779

**Acronym:** BCSSC

**Brief Title:** Biopotentials for Clinician Satisfaction With Sedation in Colonoscopy

**Official Title:** Biopotentials for Clinician Satisfaction With Sedation in Colonoscopy

#### Organization Study ID Info
**ID:** BCSSC
#### Organization
**Class:** OTHER
**Full Name:** University of Ulm
### Status Module
#### Completion Date
**Date:** 2019-07-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-05-12

**Type:** ACTUAL

**Last Update Submit Date:** 2020-05-09

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-07-01

**Type:** ACTUAL

#### Start Date
**Date:** 2019-03-04

**Type:** ACTUAL

**Status Verified Date:** 2020-05

#### Study First Post Date
**Date:** 2019-03-04
**Type:** ACTUAL
**Study First Submit Date:** 2019-02-28
**Study First Submit QC Date:** 2019-02-28
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Ulm

#### Responsible Party

**Investigator Affiliation:** University of Ulm

**Investigator Full Name:** Alexander Hann

**Investigator Title:** Senior Gastroenterologist, Department of Gastroenterology

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Bowel Disease

**Keywords:**

- colonoscopy

- biosignals

- pain

- sedation

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 112

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** Correlation between Clinician Satisfaction with Sedation Instrument (CSSI) and observer reported pain (movements and paralinguistic sounds) during sedation

**Measure:** Correlation between clinician satisfaction with sedation and pain experienced during colonoscopy

**Time Frame:** 1 day

**Description:** Prediction of observer reported pain events (movements and paralinguistic sounds) by biopotential feature pattern.

**Measure:** Prediction of observer reported pain by biopotential feature pattern

**Time Frame:** 1 day

#### Secondary Outcomes

**Description:** Correlation between clinician satisfaction with sedation (CSSI) and sedation depth measured by Modified Observer's assessment of Alertness/Sedation Score

**Measure:** Correlation between clinician satisfaction with sedation (CSSI) and sedation depth

**Time Frame:** 1 day

**Description:** Correlation between clinician satisfaction with sedation (CSSI) and frequency of sedation use measured in relation to total examination duration.

**Measure:** Correlation between clinician satisfaction with sedation (CSSI) and frequency of sedation use

**Time Frame:** 1 day

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

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

**Time Frame:** 1 day

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

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

**Time Frame:** 1 day

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

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

**Time Frame:** 1 day

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

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

**Time Frame:** 1 day

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion Criteria:

* Pregnancy

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients scheduled at the University Hospital for a colonoscopy using propofol sedation.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ulm

**Country:** Germany

**Facility:** University Ulm

**Zip:** 89081

#### Overall Officials

**Official 1:**

**Affiliation:** University Ulm

**Name:** Alexander Hann

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

### References Module

#### 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.

**PMID:** 34222272

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000004066

- Term: Digestive System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M10444

- Name: Intestinal Diseases

- Relevance: HIGH

- As Found: Bowel Disease

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007410

- Term: Intestinal Diseases

### Misc Info Module

- Version Holder: 2024-05-24
