Efficacy and Tolerance of Telerobotic vs Standard Ultrasound Exam in Children

Sponsor

Centre Hospitalier Intercommunal Creteil (Other)

Overall Status

Completed

CT.gov ID

NCT04776174

Collaborator

ADECHOTECH (Other)

Enrollment

Locations

Arm

8.1

Actual Duration (Months)

Patients Per Site

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In children with Covid-19, the diagnosis of Kawasaki Disease (KD) and pneumonia should be made very quickly. However, the regional hospitals surrounding Paris don't have the required expertise. The use of MELODY allows the paediatric team to quickly carry out the necessary examinations while avoiding the movement of patients and the risk of contamination.

The MELODY remote system developed by the company AdEchoTech is a CE marking telemedicine technique, allowing an expert to perform an ultrasound scan on a distant patient (several hundred/thousands of kms). The Melody system makes it possible to optimize ultrasound expertise resources wherever they are located (all specialties combined) The feasibility of the clinical use of telerobotic sonography has been demonstrated in adults for abdominal, cardiac and prenatal exam. Thus, the aim of this study is to assess the feasibility of this system in children.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Device: Ultrasound using the telerobotic Melody system	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Children will be initially scanned with a telerobotic ultrasound system. Within 3 hours after the telerobotic examination, patients will be scanned by a different sonographer with similar experience and qualifications using the conventional ultrasound, who will be blinded to the findings of the telerobotic examination.Children will be initially scanned with a telerobotic ultrasound system. Within 3 hours after the telerobotic examination, patients will be scanned by a different sonographer with similar experience and qualifications using the conventional ultrasound, who will be blinded to the findings of the telerobotic examination.

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Crossover Comparison of the Efficacy and Tolerance of Telerobotic vs Standard Ultrasound Exam in Children

Actual Study Start Date :

Mar 1, 2021

Actual Primary Completion Date :

Nov 3, 2021

Actual Study Completion Date :

Nov 3, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: standard and telerobotic ultrasound Included patients will have both ultrasound examination: standard ultraosound (abdominal, cardiac or pulmonary depending on the prescription and telerobotic ultrasound	Device: Ultrasound using the telerobotic Melody system The children will first have a telerobotic ultrasound abdominal, pulmonary or cardiac followed by a classical ultrasound.

Arm

Intervention/Treatment

Experimental: standard and telerobotic ultrasound

Included patients will have both ultrasound examination: standard ultraosound (abdominal, cardiac or pulmonary depending on the prescription and telerobotic ultrasound

Device: Ultrasound using the telerobotic Melody system

The children will first have a telerobotic ultrasound abdominal, pulmonary or cardiac followed by a classical ultrasound.

Outcome Measures

Primary Outcome Measures

Number of normal and abnormal standard and telerobotic ultrasound examinations [1 day]
Number of normal and abnormal examination conclusion for telerobotic and conventional ultrasound examinations

Secondary Outcome Measures

Age of participants [At baseline]
Age of patients with telerobotic ultrasound
Number of anomalies found [Up to 4 hours]
Conventional and telerobotic ultrasound examinations results
Parent satisfaction [Up to 4 hours]
Parent satisfaction questioner for the telerobotic examination using a 5-point Liekert scale from 1: "strongly disagree" to 5: "strongly agree"
Medical assistant satisfaction [Up to 4 hours]
Medical assistant satisfaction questioner for the telerobotic examination using a 5-point Liekert scale from 1: "strongly disagree" to 5: "strongly agree"
Sonographer satisfaction [Up to 4 hours]
Sonographer satisfaction questioner for the telerobotic examination using a 5-point Liekert scale from 1: "strongly disagree" to 5: "strongly agree"

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient from 1 year to 10 years
Patient requiring an ultrasound exam (thoracic, abdominal or cardiac)
French social security affiliation

Exclusion Criteria:

Obesity defined by a BMI greater than 30
Open wound making it impossible to carry out an ultrasound scan
Algetic patient
Instability of vital functions
Impossible to remain in a seated position
Refusal to participate in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHI Créteil	Créteil		France	94000
2	CHI Villeneuve-Saint-Georges	Villeneuve-Saint-Georges		France

Sponsors and Collaborators

Centre Hospitalier Intercommunal Creteil
ADECHOTECH

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Intercommunal Creteil

ClinicalTrials.gov Identifier:

NCT04776174

Other Study ID Numbers:

CHILDMELODY

First Posted:

Mar 1, 2021

Last Update Posted:

Nov 22, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Nov 22, 2021