Impact of Digital Enhanced Telecommunication for Team Communication in Endoscopic Procedures During COVID-19 Pandemic
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Communication associated adverse events
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 68 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Member of staff of the endoscopic team (Doctor, nurse)
Exclusion Criteria
- •significantly impaired hearing
Outcomes
Primary Outcomes
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 Outcomes
- Subjective Comfort of DECT communication(From start to stop of endoscopic procedure)
- Endoscopic time(From start to stop of endoscopic procedure)
- Severe adverse events(From start to stop of endoscopic procedure)
Investigators
Thomas Seufferlein
Head of Mecical clinic 1
University of Ulm