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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Créteil, France, 94000
- CHI Créteil
-
Villeneuve-Saint-Georges, France
- CHI Villeneuve-Saint-Georges
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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)
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 |
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 |
|---|---|---|
|
Agreement Between Telerobotic and Conventional Ultrasound Examinations Assessed by Cohen Kappa Coefficient
Time Frame: 1 day
|
Agreement between telerobotic and conventional ultrasound examinations was assessed using the Cohen kappa coefficient based on the overall examination conclusions (normal or abnormal) obtained by the two methods. Kappa values range from 0 to 1, where 0 indicates no agreement beyond chance and 1 indicates perfect agreement; higher values indicate better agreement between the two examination methods. |
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parent Acceptance of Telerobotic Ultrasound
Time Frame: Up to 4 hours
|
Parents completed a 5-point Likert questionnaire immediately after the telerobotic ultrasound examination. Responses were reported as the number of participants selecting each response category. Higher levels of agreement indicate greater acceptance. |
Up to 4 hours
|
|
Patient Site 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" |
Up to 4 hours
|
|
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" |
Up to 4 hours
|
|
Duration of Ultrasound Examination
Time Frame: Within 1 day (during the paired standard and telerobotic ultrasound examinations)
|
Duration of the ultrasound examination performed using the telerobotic and conventional ultrasound systems. |
Within 1 day (during the paired standard and telerobotic ultrasound examinations)
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHILDMELODY
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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