Back to resultsImpact of Digital Communication Assist Tools in Endoscopic Team Communication During COVID-19 (EndoCom)
Primary Purpose
Endoscopy, Communication
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
DECT
Sponsored by
About this trial
This is an interventional health services research trial for Endoscopy focused on measuring endoscopy, team communication, endoscopic procedure, COVID-19
Eligibility Criteria
Inclusion Criteria:
- Member of staff of the endoscopic team (Doctor, nurse)
Exclusion Criteria:
- Deafness
- significantly impaired hearing
Sites / Locations
- Universitätsklinikum Ulm
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard Communication
DECT enhanced Communication
Arm Description
Endoscopic procedures performed by skilled endoscopic team with standard communication (no headset)
Endoscopic procedures performed by skilled endoscopic team with enhanced communication tools ( DECT headset)
Outcomes
Primary Outcome Measures
Communication associated adverse events
Adverse events arising from impaired communication by COVID-19 protection equipment
Secondary Outcome Measures
Severe adverse events
Severe adverse evatent, not arising from from impaired communication by COVID-19 protection equipment
Subjective Comfort of DECT communication
Subjectiveley perceived level of comfort using DECT communication during endoscopic procedures rated by numeric rating scale (1-6)
Endoscopic time
Duration of performed endoscopic procedures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04680858
Brief Title
Impact of Digital Communication Assist Tools in Endoscopic Team Communication During COVID-19
Acronym
EndoCom
Official Title
Impact of Digital Enhanced Telecommunication for Team Communication in Endoscopic Procedures During COVID-19 Pandemic
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
January 31, 2021 (Anticipated)
Study Completion Date
February 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ulm
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Team work is highly challenged by the COVID-19 pandemic. Necessary protective equipment as FFP-mask and face shields impair communication significantly.Objective of the study is to evalaute the impact of digital enhanced telecommunication in endoscopic procedures.
Detailed Description
Optimal communication is crucial for team work in high class endoscopy. Team work is highly challenged by the COVID-19 pandemic. Necessary protective equipment as FFP-mask and face shields impair communication significantly. Digital enhanced approaches to maintain team communication during endoscopic procedures are mandatory not only in actual circumstances.
Materials and methods:A prospective, two-armed interventional study will be performed at an endoscopy unit at a tertiary center. 200 endoscopic examinations (EGD, colonoscopy, EUS, ERCP) were randomly assigned (1:1) to a group that was performed with DECT equipped endoscopy team or with standard communication. All examinations were performed under protective equipment. Primary outcome was rate of communication associated adverse events. Secondary outcomes included team subjectively perceived comfort with DECT enhanced communication during endoscopic work, duration of examinations, SAE.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endoscopy, Communication
Keywords
endoscopy, team communication, endoscopic procedure, COVID-19
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two-armed study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard Communication
Arm Type
No Intervention
Arm Description
Endoscopic procedures performed by skilled endoscopic team with standard communication (no headset)
Arm Title
DECT enhanced Communication
Arm Type
Experimental
Arm Description
Endoscopic procedures performed by skilled endoscopic team with enhanced communication tools ( DECT headset)
Intervention Type
Other
Intervention Name(s)
DECT
Intervention Description
Use of a digital enhanced telecommunication headset for team communication
Primary Outcome Measure Information:
Title
Communication associated adverse events
Description
Adverse events arising from impaired communication by COVID-19 protection equipment
Time Frame
From start to stop of endoscopic procedure
Secondary Outcome Measure Information:
Title
Severe adverse events
Description
Severe adverse evatent, not arising from from impaired communication by COVID-19 protection equipment
Time Frame
From start to stop of endoscopic procedure
Title
Subjective Comfort of DECT communication
Description
Subjectiveley perceived level of comfort using DECT communication during endoscopic procedures rated by numeric rating scale (1-6)
Time Frame
From start to stop of endoscopic procedure
Title
Endoscopic time
Description
Duration of performed endoscopic procedures
Time Frame
From start to stop of endoscopic procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Member of staff of the endoscopic team (Doctor, nurse)
Exclusion Criteria:
Deafness
significantly impaired hearing
Facility Information:
Facility Name
Universitätsklinikum Ulm
City
Ulm
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of Digital Communication Assist Tools in Endoscopic Team Communication During COVID-19
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