RecruitingNot ApplicableNCT06231654

Evaluation of Remote Photoplethysmography to Assist Vital Signs Measure in Pediatrics

Use of Remote Photoplethysmography to Measure Heart Rate and Respiratory Rate in Pediatrics Compared to Standard Acquisition System: Prospective Comparative Trial


Sponsor

Fondation Lenval

Enrollment

600 participants

Start Date

Jul 2, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 3 YearsMax Age: 17 Years

Inclusion Criteria4

  • 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

Exclusion Criteria6

  • Patient with a neurocognitive disorder
  • Patient in immediate vital distress,
  • Known cardiac arrhythmia,
  • Scleroderma
  • Patients suffering from pathological tremors or muscle spasms that prevent them from remaining static for the duration of the measurement.
  • Parents who do not understand and/or speak French

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Interventions

DEVICERemote photoplethysmography for physiological parameters

Patients 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).


Locations(1)

Fondation Lenval - Hôpitaux Pédiatriques de Nice CHU-LENVAL

Nice, France

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NCT06231654