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

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

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.

Study Overview

• Status: Terminated
• Conditions: Tele-ultrasound
• Intervention / Treatment: Other: Dual ultrasound reading "local vs remote"; Other: Dual ultrasound reading "local vs local"

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 Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Metz, France, 57085
    • CHR Metz Thionville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Local vs remote group; The examination will be interpreted by a department's radiologist and by a remote radiologist in blind of the first interpretation	Other: 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 and a posteriori by a third radiologist.
Other: Local vs local group; The examination will be interpreted by two department's radiologists	Other: Dual ultrasound reading "local vs local"; The examination will be interpreted by two department's radiologists and a posteriori by a third radiologist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of consistency between the reports	It will be evaluated in blind by a third radiologist with the RADPEER scoring.	Day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional Metz-Thionville
• Investigators: Principal Investigator: Elisabeth PARIZEL, MD, CHR Metz Thionville

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2018
• Primary Completion (Actual): March 13, 2020
• Study Completion (Actual): March 13, 2020

Study Registration Dates

• First Submitted: June 1, 2018
• First Submitted That Met QC Criteria: June 12, 2018
• First Posted (Actual): June 13, 2018

Study Record Updates

• Last Update Posted (Actual): October 7, 2022
• Last Update Submitted That Met QC Criteria: October 6, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2016-04-CHRMT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No