Tele-ultrasound Experimentation: Cooperation Protocol Between Electro-radiology Assistant and Remote Radiologist

Not Applicable

Terminated

• Conditions: Tele-ultrasound
• Interventions: Other: Dual ultrasound reading "local vs remote"; Other: Dual ultrasound reading "local vs local"

• Registration Number: NCT03555006
• Lead Sponsor: Centre Hospitalier Régional Metz-Thionville

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-06-01
• Study First Submitted QC: 2018-06-12
• Study First Posted: 2018-06-13
• Study Start: 2018-10-16
• Primary Completion: 2020-03-13
• Study Completion: 2020-03-13
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-06
• Last Update Posted: 2022-10-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Local vs remote group	Dual ultrasound reading "local vs remote"	The examination will be interpreted by a department's radiologist and by a remote radiologist in blind of the first interpretation
Local vs local group	Dual ultrasound reading "local vs local"	The examination will be interpreted by two department's radiologists

Primary Outcome Measures

Name	Time	Method
Percentage of consistency between the reports	Day 1	It will be evaluated in blind by a third radiologist with the RADPEER scoring.

Trial Locations

Locations (1)

CHR Metz Thionville; 🇫🇷 Metz, France