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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-16

Study Completion Date

2020-03-13

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tele-ultrasound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Dual ultrasound reading "local vs remote"

Intervention Type OTHER

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.

Local vs local group

The examination will be interpreted by two department's radiologists

Group Type OTHER

Dual ultrasound reading "local vs local"

Intervention Type OTHER

The examination will be interpreted by two department's radiologists and a posteriori by a third radiologist.

Interventions

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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.

Intervention Type OTHER

Dual ultrasound reading "local vs local"

The examination will be interpreted by two department's radiologists and a posteriori by a third radiologist.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No