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OpenTrials
Completed

NCT Number: NCT04776174

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

1 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHI Créteil, Créteil, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound using the telerobotic Melody system

Device

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

Primary outcomes

  1. Number of normal and abnormal standard and telerobotic ultrasound examinations

    Time frame: 1 day

    Number of normal and abnormal examination conclusion for telerobotic and conventional ultrasound examinations

Secondary outcomes

  1. Age of participants

    Time frame: At baseline

    Age of patients with telerobotic ultrasound

  2. Number of anomalies found

    Time frame: Up to 4 hours

    Conventional and telerobotic ultrasound examinations results

  3. Parent satisfaction

    Time frame: 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"

  4. Medical assistant satisfaction

    Time frame: 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"

  5. Sonographer satisfaction

    Time frame: 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"

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Creteil

Other

Collaborators

  • ADECHOTECH

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 1, 2021
Registry last updated
Nov 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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