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Clinical Trials/NCT06231654
NCT06231654RecruitingNot Applicable

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

Fondation Lenval1 site in 1 country600 target enrollmentStarted: July 2, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
600
Locations
1
Primary Endpoint
measure of heart rate (HR) with remote photo-plethysmography (rPPG) at 30 seconds of recording

Study Overview

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

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
3 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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 Criteria

  • •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

Arms & Interventions

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.

Intervention: Remote photoplethysmography for physiological parameters (Device)

Outcomes

Primary Outcomes

measure of heart rate (HR) with remote photo-plethysmography (rPPG) at 30 seconds of recording

Time Frame: at inclusion

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

Secondary Outcomes

  • HR measurement using rPPG at 60 seconds of recording(at inclusion)
  • parental satisfaction(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)
  • failure rates of measurements(at inclusion)
  • Participant Satisfaction(at inclusion)

Investigators

Sponsor
Fondation Lenval
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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