NCT04680858

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 23, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2021

Completed
Last Updated

December 31, 2020

Status Verified

December 1, 2020

Enrollment Period

7 months

First QC Date

December 17, 2020

Last Update Submit

December 28, 2020

Conditions

EndoscopyCommunication

Keywords

endoscopyteam communicationendoscopic procedureCOVID-19

Outcome Measures

Primary Outcomes (1)

  • Communication associated adverse events

    Adverse events arising from impaired communication by COVID-19 protection equipment

    From start to stop of endoscopic procedure

Secondary Outcomes (3)

  • Severe adverse events

    From start to stop of endoscopic procedure

  • Subjective Comfort of DECT communication

    From start to stop of endoscopic procedure

  • Endoscopic time

    From start to stop of endoscopic procedure

Study Arms (2)

Standard Communication

NO INTERVENTION

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

DECT enhanced Communication

EXPERIMENTAL

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

Other: DECT

Interventions

DECTOTHER

Use of a digital enhanced telecommunication headset for team communication

DECT enhanced Communication

Eligibility Criteria

Age18 Years - 68 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Deafness
  • significantly impaired hearing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Ulm

Ulm, Germany

Location

MeSH Terms

Conditions

CommunicationCOVID-19

Condition Hierarchy (Ancestors)

BehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Two-armed study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Mecical clinic 1

Study Record Dates

First Submitted

December 17, 2020

First Posted

December 23, 2020

Study Start

July 1, 2020

Primary Completion

January 31, 2021

Study Completion

February 15, 2021

Last Updated

December 31, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)