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

Tele-ultrasound Clinical Trial

— TELECHO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03555006
• Other study ID #: 2016-04-CHRMT
• Status: Terminated
• Phase: N/A
• Start date: October 16, 2018
• Est. completion date: March 13, 2020

Study information

• Verified date: October 2022
• Source: Centre Hospitalier Régional Metz-Thionville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 104
• Est. completion date: March 13, 2020
• Est. primary completion date: March 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tele-ultrasound

Intervention

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.
• Dual ultrasound reading "local vs local"
The examination will be interpreted by two department's radiologists and a posteriori by a third radiologist.

Locations

Country	Name	City	State
France	CHR Metz Thionville	Metz

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional Metz-Thionville

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of consistency between the reports	It will be evaluated in blind by a third radiologist with the RADPEER scoring.	Day 1