Efficacy and Tolerance of Telerobotic vs Standard Ultrasound Exam in Children

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

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Device: Ultrasound using the telerobotic Melody system

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Créteil, France, 94000
    • Chi Creteil
  • Villeneuve-Saint-Georges, France
    • CHI Villeneuve-Saint-Georges

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil
• Collaborators: ADECHOTECH

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): November 3, 2021
• Study Completion (Actual): November 3, 2021

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): November 22, 2021
• Last Update Submitted That Met QC Criteria: November 19, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CHILDMELODY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No