Clinical trial NCT06231654: Evaluation of Remote Photoplethysmography to Assist Vital Signs Measure in Pediatrics
Official title: Use of Remote Photoplethysmography to Measure Heart Rate and Respiratory Rate in Pediatrics Compared to Standard Acquisition System: Prospective Comparative Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Using Remote Photoplethysmography for Physiological Parameters
Lead sponsor: Fondation Lenval
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 600
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: measure of heart rate (HR) with remote photo-plethysmography (rPPG) at 30 seconds of recording
timeFrame: at inclusion
Secondary outcomes:
measure: HR measurement using rPPG at 60 seconds of recording
timeFrame: at inclusion
measure: FR measurement using rPPG (60-second recording)
timeFrame: at inclusion
measure: FR measurement using rPPG (30-second recording)
timeFrame: at inclusion
measure: FR measurement using rPPG according to the age ranges ranking
timeFrame: at 12 months
measure: HR measurement using rPPG according to the age ranges ranking
timeFrame: at 12 months
measure: parental satisfaction
timeFrame: at inclusion
measure: failure rates of measurements
timeFrame: at 12 months
Other outcomes:
Locations:
city: Nice
country: France
facility: Fondation Lenval - Hôpitaux Pédiatriques de Nice CHU-LENVAL
Study officials:
References: