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

NCT ID: NCT04680858

Last Updated: 2020-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-02-15

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.

Conditions

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Endoscopy Communication

Keywords

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endoscopy team communication endoscopic procedure COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two-armed study
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Standard Communication

Endoscopic procedures performed by skilled endoscopic team with standard communication (no headset)

Group Type NO_INTERVENTION

No interventions assigned to this group

DECT enhanced Communication

Endoscopic procedures performed by skilled endoscopic team with enhanced communication tools ( DECT headset)

Group Type EXPERIMENTAL

DECT

Intervention Type OTHER

Use of a digital enhanced telecommunication headset for team communication

Interventions

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DECT

Use of a digital enhanced telecommunication headset for team communication

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Member of staff of the endoscopic team (Doctor, nurse)

Exclusion Criteria

* Deafness
* significantly impaired hearing
Minimum Eligible Age

18 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ulm

OTHER

Sponsor Role lead

Responsible Party

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Thomas Seufferlein

Head of Mecical clinic 1

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universitätsklinikum Ulm

Ulm, , Germany

Site Status

Countries

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Germany

Other Identifiers

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122020

Identifier Type: -

Identifier Source: org_study_id