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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04680858
Recruitment Status : Enrolling by invitation
First Posted : December 23, 2020
Last Update Posted : December 31, 2020
Sponsor:
Information provided by (Responsible Party):
Thomas Seufferlein, University of Ulm

Study Description
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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.

Condition or disease Intervention/treatment Phase
Endoscopy Communication Other: DECT Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two-armed study
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Impact of Digital Enhanced Telecommunication for Team Communication in Endoscopic Procedures During COVID-19 Pandemic
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : February 15, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Standard Communication
Endoscopic procedures performed by skilled endoscopic team with standard communication (no headset)
Experimental: DECT enhanced Communication
Endoscopic procedures performed by skilled endoscopic team with enhanced communication tools ( DECT headset)
 Other: DECT
Use of a digital enhanced telecommunication headset for team communication


Outcome Measures
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Primary Outcome Measures :
  1. Communication associated adverse events [ Time Frame: From start to stop of endoscopic procedure ]
    Adverse events arising from impaired communication by COVID-19 protection equipment


Secondary Outcome Measures :
  1. Severe adverse events [ Time Frame: From start to stop of endoscopic procedure ]
    Severe adverse evatent, not arising from from impaired communication by COVID-19 protection equipment

  2. Subjective Comfort of DECT communication [ Time Frame: From start to stop of endoscopic procedure ]
    Subjectiveley perceived level of comfort using DECT communication during endoscopic procedures rated by numeric rating scale (1-6)

  3. Endoscopic time [ Time Frame: From start to stop of endoscopic procedure ]
    Duration of performed endoscopic procedures


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Deafness
  • significantly impaired hearing
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04680858


Locations
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Germany
Universitätsklinikum Ulm
Ulm, Germany
Sponsors and Collaborators
University of Ulm
More Information
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Responsible Party: Thomas Seufferlein, Head of Mecical clinic 1, University of Ulm
ClinicalTrials.gov Identifier: NCT04680858    
Other Study ID Numbers: 122020
First Posted: December 23, 2020    Key Record Dates
Last Update Posted: December 31, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thomas Seufferlein, University of Ulm:
endoscopy
team communication
endoscopic procedure
COVID-19
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases