Efficacy and Tolerance of Telerobotic vs Standard Ultrasound Exam in Children

Not Applicable

Completed

• Conditions: Covid19
• Interventions: Device: Ultrasound using the telerobotic Melody system

• Registration Number: NCT04776174
• Lead Sponsor: Centre Hospitalier Intercommunal Creteil

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-02-26
• Study Start: 2021-03-01
• Study First Posted: 2021-03-01
• Status Verified: 2021-11
• Primary Completion: 2021-11-03
• Study Completion: 2021-11-03
• Last Update Submitted: 2021-11-19
• Last Update Posted: 2021-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
standard and telerobotic ultrasound	Ultrasound using the telerobotic Melody system	Included patients will have both ultrasound examination: standard ultraosound (abdominal, cardiac or pulmonary depending on the prescription and telerobotic ultrasound

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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"
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"
Age of participants	At baseline	Age of patients with telerobotic ultrasound
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"

Trial Locations

Locations (2)

CHI Créteil; 🇫🇷 Créteil, France

CHI Villeneuve-Saint-Georges; 🇫🇷 Villeneuve-Saint-Georges, France