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临床试验/NCT04680858
NCT04680858Unknown不适用

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

University of Ulm1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
试验地点
1
主要终点
Communication associated adverse events

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 68 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • significantly impaired hearing

结局指标

主要结局

Communication associated adverse events

时间窗: From start to stop of endoscopic procedure

Adverse events arising from impaired communication by COVID-19 protection equipment

次要结局

  • 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)

研究者

发起方
University of Ulm
申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas Seufferlein

Head of Mecical clinic 1

University of Ulm

研究点 (1)

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