Efficacy and Tolerance of Telerobotic vs Standard Ultrasound Exam in Children

Centre Hospitalier Intercommunal Creteil

Status: Completed

Conditions: Covid19

Treatments: Device: Ultrasound using the telerobotic Melody system

Study type: Interventional

Funder types: Other

Identifiers

NCT04776174

CHILDMELODY

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 1 to 10 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

standard and telerobotic ultrasound

Experimental group

Description:

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

Treatment:

Device: Ultrasound using the telerobotic Melody system