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Using Remote Photoplethysmography for Physiological ParametersrMonitoped1NCT06231654

Evaluation of Remote Photoplethysmography to Assist Vital Signs Measure in Pediatrics

A study testing Remote photoplethysmography for physiological parameters in people with Using Remote Photoplethysmography for Physiological Parameters, run by Fondation Lenval at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 17 years
What is being tested?
Remote photoplethysmography for physiological parameters
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
1 siteFrance
Study dates
2 Jul 2025to 2 Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site, 1 recruiting
  • Fondation Lenval - Hôpitaux Pédiatriques de Nice CHU-LENVAL

    Nice, 06200

    Antoine TRAN, MCU-MD, 04-92-03-04-42, antoine.tran@hpu.lenval.com

    Aline JOULIE, 04.92.03.05.20 ext. +33, joulie.a@chu-nice.fr

    Recruiting

Other trials in France

About this study

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

Read the detailed description

When assessing a child's clinical condition, the vulnerability of the child means is the needs to assess quickly and simply his vital status. Although several parameters are available to evaluate a potential life-threatening condition in pediatrics, the initial measurement of vital constants provides the clinician an immediate assessment about how much the vital status of the child is good or not. More particularly, heart rate (HR), respiratory rate (RR), oxygen saturation and blood pressure are defined as objective markers of a child's circulatory and respiratory status. In practice, manual measurements such as pulse palpation or thoracic ampliation counting are obsolete. A number of methods of measure are commonly used. Electrical recording via ECG electrodes or pulse counting via an oximeter can be used to measure heart rate. Respiratory rate can be measured using chest electrodes to assess its ampliation. In any emergency room, the collection of these constants requires a variety of medical devices that are usually time-consuming and human resources to collect them exhaustively and reliably. Moreover, these measurements may not be carried out under optimal conditions with children who may not be compliant, with as a result a lack of reliability or a missing measurement.

In adults, new and innovative measurement methods have emerged that offer acceptable reliability and accuracy compared with current reference methods. These include remote photo-plethysmography (rPPG), a process that enables vital constants to be assessed using a simple camera recording of the face over a short period of time.

Photoplethysmography (PPG) detect blood volume in the micro-vessels of tissues on the skin's surface. With each heartbeat, the volume in the arteries and arterioles changes. It is this variation that is measured using a LED placed mostly on the finger, ear or forehead.

Remote photoplethysmography (rPPG) is a non-invasive optical method for detecting pulse waves generated by the heart through measurements of peripheral blood perfusion. This technology may replace standard medical devices because of its ease of use, its low cost, its safety, convenience and its ability to offer multiple physiological assessments.

The company I-Virtual has enabled the development of this technique, whose technology is based on the analysis of different skin color spectra in the face, in order to determine a signal at the origin of these constants.

The Caducy® application using the rPPG technique can be downloaded onto a wide range of media. Using this app is quick and easy and requires to take a selfie using any camera available on a smartphone, tablet or computer at a sufficient distance ( the whole face should be visible on the screen). The application then takes between 30 seconds and 1 minute to analyze the various parameters. On January 25, 2023, i-Virtual obtained CE Class IIa certification for its Caducy® medical device, which measures vital signs via webcam. It thus became the first company in the world with this type of technology to obtain CE marking.

However, it has never been studied in pediatric patients. And yet, this easy-to-use, fast, material-saving application, certified for adult patients, could alleviate the difficulties of measuring vital signs in pediatrics that's mentioned earlier. In partnership with I-Virtual, the investigator would therefore like to test the use of remote photo-plethysmography or rPPG via its Caducy® application in pediatrics. The objective of the study is to evaluate the use of remote photoplethysmography to measure heart rate and respiratory rate in pediatric patients compared to standard acquisition system

Being tested
Remote photoplethysmography for physiological parameters

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Remote photoplethysmography for physiological parametersDevice

    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).

Study groups in NCT06231654
Study groupRoleWhat they receive
patentsExperimentalthe 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.
Receives: Device: Remote photoplethysmography for physiological parameters

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: at inclusion

Secondary outcomes (8)
  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

    Measured: at inclusion

  2. RR measurement using rPPG (60-second recording)

    Evaluate the reliability of RR measurement using rPPG (60-second recording) compared to electrode system.

    Measured: at inclusion

  3. RR measurement using rPPG (30-second recording)

    Evaluate the reliability of RR measurement using rPPG (30-second recording) compared to electrode system.

    Measured: at inclusion

  4. 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

    Measured: at inclusion

  5. HR measurement using rPPG according to the age ranges ranking

    Evaluate the reliability of HR 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

    Measured: at inclusion

  6. parental satisfaction

    Evaluation of parental satisfaction with the application with likert Scale

    Measured: at inclusion

  7. failure rates of measurements

    Estimation of failure rates of measurements with each of the techniques (rPPG and electrodes).

    Measured: at inclusion

  8. Participant Satisfaction

    • Evaluation of participant satisfaction (children/adolescents aged 3-17 years) with the application with Likert Scale

    Measured: at inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2024
  2. Study start2 Jul 2025
  3. Primary completion2 Jul 2026 (estimated)
  4. Study completion2 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06231654
Sponsor's protocol ID
23-HNCL-06
Acronym
rMonitoped1
Status last verified
Jan 2026
First submitted
21 Dec 2023
Last updated
28 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41856588

Questions about this trial

What is this clinical trial studying?

A study testing Remote photoplethysmography for physiological parameters in people with Using Remote Photoplethysmography for Physiological Parameters, run by Fondation Lenval at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Antoine TRAN, MCU-MD (04-92-03-04-42, antoine.tran@hpu.lenval.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

measure of heart rate (HR) with remote photo-plethysmography (rPPG) at 30 seconds of recording (time frame: at inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06231654, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.

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