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

Communication Clinical Trial

— EndoCom  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04680858
• Other study ID #: 122020
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: February 15, 2021

Study information

• Verified date: December 2020
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: February 15, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 68 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Deafness

• significantly impaired hearing

Related Conditions & MeSH terms

• Communication
• Endoscopy

Intervention

Other:
• DECT
Use of a digital enhanced telecommunication headset for team communication

Locations

Country	Name	City	State
Germany	Universitätsklinikum Ulm	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Communication associated adverse events	Adverse events arising from impaired communication by COVID-19 protection equipment	From start to stop of endoscopic procedure
Secondary	Severe adverse events	Severe adverse evatent, not arising from from impaired communication by COVID-19 protection equipment	From start to stop of endoscopic procedure
Secondary	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
Secondary	Endoscopic time	Duration of performed endoscopic procedures	From start to stop of endoscopic procedure