Efficacy and Tolerance of Telerobotic vs Standard Ultrasound Exam in Children

NCT04776174 | Completed

• 1 other identifier: CHILDMELODY
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Age of participants

  At baseline

• Number of anomalies found

  Up to 4 hours

• Parent satisfaction

  Up to 4 hours

• Medical assistant satisfaction

  Up to 4 hours

• Sonographer satisfaction

  Up to 4 hours

Study Arms (1)

standard and telerobotic ultrasound

EXPERIMENTAL

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

Interventions

Ultrasound using the telerobotic Melody system DEVICE

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

standard and telerobotic ultrasound

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead
• ADECHOTECH: collaborator

Study Sites (2)

CHI Créteil

Créteil, 94000, France

Location

CHI Villeneuve-Saint-Georges

Villeneuve-Saint-Georges, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: March 1, 2021
• Study Start: March 1, 2021
• Primary Completion: November 3, 2021
• Study Completion: November 3, 2021
• Last Updated: November 22, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)