Evaluation of Remote Photoplethysmography to Assist Vital Signs Measure in Pediatrics
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-17
SponsorFondation Lenval
About this trial
Introduced in 1930, photoplethysmography techniques presented the possibility of measuring SpO2 and heart rates (HR) using the absorption of light by the blood to define these signals. In recent years, a new approach to photoplethysmography to measure physiological parameters without contact has been developed. This technique, called remote Photoplethysmography Imaging (rPPG), uses the different Red - Green - Blue color spectra at a skin captured by the camera video to determine a plethysmography signal. However, it has never been studied in pediatric patients. The objective is to evaluate the remote photoplethysmography technology to measure vital signs in pediatrics
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children under 18 and over 3 years of age
Any reason for consultation or hospitalization
Written and signed informed consent from one parent or the person with parental authority,
Membership of a social security scheme
Disqualifiers
Patient with a neurocognitive disorder
Patient in immediate vital distress,
Known cardiac arrhythmia,
Scleroderma
Trial design
Design model
Single group
Treatments tested in this trial
Remote photoplethysmography for physiological parameters
DevicePatients participating in the study will be recruited from our emergency department. The child will be placed in a dedicated, quiet, well-lit office with their parents. The following data are then collected: sex, age, phototype according to Fitzpatrick's classification. The child sits in a chair facing a camera connected to a laptop running Caducy® Medical Device software. At the same time, and following the usual procedure, three ECG electrodes will be positioned on the patient. The whole device is connected to our standard device. Once the child is immobile and ready, the Caducy® application is launched. At the same time, our standard device is activated. After 30 seconds, we will collect the HR and FR values revealed by the Caducy® application via the non-contact plethysmography method. On the other hand, it will collect the HR and FR values revealed by our standard device (Mindray® scope).
Treatment groups
600 Participants
are divided into 1 treatment groupGroup A: patentsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
measure of heart rate (HR) with remote photo-plethysmography (rPPG) at 30 seconds of recording
Assess the reliability of HR measurement using the rPPG at 30 seconds of recording versus that measured using ECG electrodes, the method taken as the gold standard, in a pediatric population
Time frame
at inclusionSecondary outcomes
1
HR measurement using rPPG at 60 seconds of recording
Evaluate the reliability of HR measurement using rPPG (60-second recording) compared to ECG electrodes
Time frame
at inclusion2
RR measurement using rPPG (60-second recording)
Evaluate the reliability of RR measurement using rPPG (60-second recording) compared to electrode system.
Time frame
at inclusion3
RR measurement using rPPG (30-second recording)
Evaluate the reliability of RR measurement using rPPG (30-second recording) compared to electrode system.
Time frame
at inclusion4
RR measurement using rPPG according to the age ranges ranking
Evaluate the reliability of RR measurement using rPPG at 30-second recording according to the age ranges ranking as the different periods of childhood \[3y-7y\[, \[7y-12y\[, \[12y-18y\[ and the patient phototype according to Fitzpatrick's classification
Time frame
at inclusionSponsors and contacts
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Source ClinicalTrials.gov