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

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

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.

Study Overview

• Status: Unknown
• Conditions: Communication; Endoscopy
• Intervention / Treatment: Other: DECT

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 Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Ulm, Germany
    • Universitätsklinikum Ulm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Deafness
• significantly impaired hearing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Ulm

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): January 31, 2021
• Study Completion (Anticipated): February 15, 2021

Study Registration Dates

• First Submitted: December 17, 2020
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (Actual): December 23, 2020

Study Record Updates

• Last Update Posted (Actual): December 31, 2020
• Last Update Submitted That Met QC Criteria: December 28, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: COVID-19; endoscopy; endoscopic procedure; team communication
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 122020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No