Effekt och tolerans av Telerobotic vs standard ultraljudsundersökning hos barn
Crossover-jämförelse av effektiviteten och toleransen av Telerobotic vs standard ultraljudsundersökning hos barn
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Créteil, Frankrike, 94000
- CHI Créteil
-
Villeneuve-Saint-Georges, Frankrike
- CHI Villeneuve-Saint-Georges
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Agreement Between Telerobotic and Conventional Ultrasound Examinations Assessed by Cohen Kappa Coefficient
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Parent Acceptance of Telerobotic Ultrasound
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
|
Samarbetspartners och utredare
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CHILDMELODY
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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