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

University of Ulm

Status: Unknown

Conditions: Communication; Endoscopy

Treatments: Other: DECT

Study type: Interventional

Funder types: Other

Identifiers

NCT04680858

122020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 68 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Deafness
• significantly impaired hearing

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

500 participants in 2 patient groups

Standard Communication

No Intervention group

Description:

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

DECT enhanced Communication

Experimental group

Description:

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

Treatment:

Other: DECT