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

Sponsor
Centre Hospitalier Régional Metz-Thionville (Other)
Overall Status
Recruiting
CT.gov ID
NCT03555006
Collaborator
(none)
470
1
2
48.5
9.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Dual ultrasound reading "local vs remote"
  • Other: Dual ultrasound reading "local vs local"
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
470 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Tele-ultrasound Experimentation: Cooperation Protocol Between Electro-radiology Assistant and Remote Radiologist for the Realization of Some Exploration Indications by Ultrasound
Actual Study Start Date :
Oct 16, 2018
Anticipated Primary Completion Date :
Oct 16, 2022
Anticipated Study Completion Date :
Oct 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Percentage of consistency between the reports [Day 1]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHR Metz Thionville Metz France 57085

Sponsors and Collaborators

  • Centre Hospitalier Régional Metz-Thionville

Investigators

  • Principal Investigator: Elisabeth PARIZEL, MD, CHR Metz Thionville

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Régional Metz-Thionville
ClinicalTrials.gov Identifier:
NCT03555006
Other Study ID Numbers:
  • 2016-04-CHRMT
First Posted:
Jun 13, 2018
Last Update Posted:
Jun 14, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 14, 2021