Comparison of Continuous Non-invasive All Vital Signs Monitoring Devices With Invasive Gold Standard for Children

Study Overview
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Brief Summary
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In this clinical study, the investigator will compare vital signs measurements obtained using the non-invasive, wireless VitalTracert monitoring devices (both a VT-Watch and a VT-Patch) to a proprietary continuous physiological data collection tool in 40 patients including 16 patients with an invasive arterial line catheter (radial or femoral) at the pediatric intensive care unit.

Detailed Description
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Detailed Description: The VitalTracer non-invasive, wireless monitoring device is based on reflective photoplethysmograph (PPG) technology. It measures several vital signs, including Oxygen saturation, ECG, blood pressure, respiratory rate, heart rate and skin temperature. The data is transmitted to VitalTracer's application (in Google Play) and is available as a full monitoring system in a hospital setting. The aim of this study is to compare the VitalTracer monitor with the invasive method of blood pressure and SPO2 measurements. The study population includes 40 patients admitted to NICU and PICU. Once in the intensive care unit, the investigator will attach the VitalTracer non-invasive monitor (both a VT-watch and a VT-patch), which are identical in terms of the monitoring system, and monitor the participants for 24 hours. Though both methods are continuous, the investigator will record the vital signs every 1 minute during the 24 hours of the study.

Official Title
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Validation of Vital Signs Recording With VT-Patch® or VT-Watch® Connected Devices in Children Hospitalized in NICU and PICU

Conditions
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Oxygen Saturation, Children, Vital Signs, Blood Pressure, Hypertension, Neonatal, Intensive Care Unit

Intervention / Treatment
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* Device: Non-invasive monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PICU monitoring for the next 24 hours Exclusion Criteria: Recent cardiac or thoracic surgery Thoracic skin lesion that contraindicates the VT patch No parental consent Intermittent presence of one study observer in the patient room considered inappropriate by the physician or the nurse in charge because of the child's medical condition

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Non-invasive monitoring|Comparison of VitalTracer monitoring devices with invasive and/or non-invasive gold standard reference|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of VitalTracer devices Oxygen Saturation (SPO2) measurement | Percentage of the difference between the absolute value of SpO2 recorded by VT-Patch® or VT-Watch® and the one recorded in high resolution database. | 24 hours per subject | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of VitalTracer devices blood pressure, heart rate, skin temperature, and Electrocardiogram (ECG) measurement. | Percentage of the difference between the absolute value of Blood Pressure, Heart Rate and skin temperature and the quality of ECG signals recorded by the VT-Patch® or VT-Watch® and the one recorded in high resolution database. | 24 hours per subject | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wearable, Vital signs, SPO2, ECG, Continuous, Blood pressure, Skin temperature, Heart rate, VitalTracer, All-in-one, Children, PICU, NICU, Fitzpatrick scale, Different Skin Color, Dark skin color