Impact of Digital Communication Assist Tools in Endoscopic Team Communication During COVID-19

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Digital Enhanced Telecommunication for Team Communication in Endoscopic Procedures During COVID-19 Pandemic

Conditions
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Endoscopy, Communication

Intervention / Treatment
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* Other: DECT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Member of staff of the endoscopic team (Doctor, nurse) Exclusion Criteria: Deafness significantly impaired hearing

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two-armed study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Communication<br>Endoscopic procedures performed by skilled endoscopic team with standard communication (no headset) | |
| Experimental: DECT enhanced Communication<br>Endoscopic procedures performed by skilled endoscopic team with enhanced communication tools ( DECT headset) | Other: DECT<br>* Use of a digital enhanced telecommunication headset for team communication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Communication associated adverse events | Adverse events arising from impaired communication by COVID-19 protection equipment | From start to stop of endoscopic procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe adverse events | Severe adverse evatent, not arising from from impaired communication by COVID-19 protection equipment | From start to stop of endoscopic procedure | 
| Subjective Comfort of DECT communication | Subjectiveley perceived level of comfort using DECT communication during endoscopic procedures rated by numeric rating scale (1-6) | From start to stop of endoscopic procedure | 
| Endoscopic time | Duration of performed endoscopic procedures | From start to stop of endoscopic procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endoscopy, team communication, endoscopic procedure, COVID-19