Efficacy and Tolerance of Telerobotic vs Standard Ultrasound Exam in Children

Study Overview
=================
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.

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

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Device: Ultrasound using the telerobotic Melody system


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 10 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: standard and telerobotic ultrasound<br>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<br>* The children will first have a telerobotic ultrasound abdominal, pulmonary or cardiac followed by a classical ultrasound.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of normal and abnormal standard and telerobotic ultrasound examinations | Number of normal and abnormal examination conclusion for telerobotic and conventional ultrasound examinations | 1 day | 

Secondary Outcome Measures

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