跳至主要内容
临床试验/NCT03555006
NCT03555006终止不适用

Tele-ultrasound Experimentation: Cooperation Protocol Between Electro-radiology Assistant and Remote Radiologist for the Realization of Some Exploration Indications by Ultrasound

Centre Hospitalier Régional Metz-Thionville2 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2018年10月16日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
104
试验地点
2
主要终点
Percentage of consistency between the reports

研究概览

简要总结

This study tries to evaluate the non-inferiority quality and safety of ultrasound examinations realise by electro-radiology assistant with a remote radiologist compared to those realize by electro-radiology assistant with a referent radiologist on site.

详细描述

The number of requests for medical imaging examinations is clearly growing while there is an understaffing among the radiologists. The solution is the amelioration of information transmission technologies, for organize a territorial teleradiology in order to care duty. Currently, in the ultrasound field, the investigators can't realize image transfer because analyse and expertise are made during examination and only reading of fixed images can't be enough for the examination interpretation.

The most part of other developed countries recognize a paramedical job devoted to ultrasound. Tele-ultrasound is used in expert resort, for example during high-risk pregnancy.

A French society commercializes tele-ultrasound robots, arranged by a caregiver beside sick person and a tele-radiologist realize acquisition of information and images with remote commands from robot.

The CHR Metz-Thionville has a cooperation protocol between electro-radiology assistants and radiologists for the ultrasound practical, endorsed by Lorraine ARS and HAS (French health organizations) since 2012, and currently national impact.

This study purpose to evaluation the non-inferiority of agreement between two interpretations of the same ultrasound realize by an electro-radiology assistant on the one hand by two radiologists present in the radiology service and on the other hand, one radiologist in by the radiology service and one remote radiologist.

研究设计

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

入排标准

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

入选标准

  • Major patient
  • Who needs abdomino-pelvic ultrasound, except emergency cases
  • With no substitutable examination

排除标准

  • Pregnant and nursing women
  • Patient in the incapacity to express his consent
  • Unavailability of a remote radiologist or a second local radiologist during the examination realization
  • Patient opposed to use data

结局指标

主要结局

Percentage of consistency between the reports

时间窗: Day 1

It will be evaluated in blind by a third radiologist with the RADPEER scoring.

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier Régional Metz-Thionville
申办方类型
Other
责任方
Sponsor

研究点 (2)

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