Efficacy and Tolerance of Telerobotic vs Standard Ultrasound Exam in Children

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04776174
• Other study ID #: CHILDMELODY
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: November 3, 2021

Study information

• Verified date: November 2021
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 3, 2021
• Est. primary completion date: November 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Device:
• Ultrasound using the telerobotic Melody system
The children will first have a telerobotic ultrasound abdominal, pulmonary or cardiac followed by a classical ultrasound.

Locations

Country	Name	City	State
France	CHI Créteil	Créteil
France	CHI Villeneuve-Saint-Georges	Villeneuve-Saint-Georges

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil	ADECHOTECH

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Age of participants	Age of patients with telerobotic ultrasound	At baseline
Secondary	Number of anomalies found	Conventional and telerobotic ultrasound examinations results	Up to 4 hours
Secondary	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
Secondary	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
Secondary	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