Evaluation of Remote Photoplethysmography to Assist Vital Signs Measure in Pediatrics

NCT06231654 | Recruiting

• 1 other identifier: 23-HNCL-06
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Using Remote Photoplethysmography for Physiological Parameters

Outcome Measures

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

  at inclusion

Secondary Outcomes (8)

• HR measurement using rPPG at 60 seconds of recording

  at inclusion

• RR measurement using rPPG (60-second recording)

  at inclusion

• RR measurement using rPPG (30-second recording)

  at inclusion

• RR measurement using rPPG according to the age ranges ranking

  at inclusion

• HR measurement using rPPG according to the age ranges ranking

  at inclusion

Study Arms (1)

patents

EXPERIMENTAL

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.

Device: Remote photoplethysmography for physiological parameters

Interventions

Remote photoplethysmography for physiological parameters DEVICE

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).

patents

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Lenval: lead

Study Sites (1)

Fondation Lenval - Hôpitaux Pédiatriques de Nice CHU-LENVAL

Nice, 06200, France

RECRUITING

Related Publications (1)

• Haas-Ferrua S, Giaccardi H, Ancey B, Freyssinet E, Baranton E, Joulie A, Bendimerad I, Olla M, De Oliveira F, Moussaoui A, Boyer L, Fontas E, Tran A. Measurement of heart rate and respiratory rate using remote photoplethysmography in paediatrics: a prospective comparative trial protocol - 'rMonitoped1'. BMJ Open. 2026 Mar 19;16(3):e104840. doi: 10.1136/bmjopen-2025-104840.

  PMID: 41856588 DERIVED

Central Study Contacts

Antoine TRAN, MCU-MD

CONTACT

04-92-03-04-42; antoine.tran@hpu.lenval.com

Marco OLLA, MD

CONTACT

04-92-03-04-42; marco.olla@hpu.lenval.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 30, 2024
• Study Start: July 2, 2025
• Primary Completion (Estimated): July 2, 2026
• Study Completion (Estimated): July 2, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)