Non Contact Measurement of Vital Signs

Study Overview
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Brief Summary
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The purpose of this study is to test the accuracy of a web cam-based biomedical device developed at UVA (not FDA-approved) that is designed to measure heart rate, respiratory rate, and oxygen saturation without requiring any patient contact. One potential application of such a device would be in the field of infant monitoring allowing parents (and physicians) to monitor the vital signs of infants continuously. The investigators therefore propose to record the heart rate, respiratory rate, and oxygen saturation of 100 infants (defined as children aged 12 months or less) who are receiving continuous oxygen, heart rate, and respiratory rate monitoring with a traditional vital signs monitor. The relationship between non-contact and gold standard (GE monitoring equipment) heart rate, respiratory rate, and oxygen saturation will be analyzed using regression and limits of agreement analysis.

Detailed Description
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While multiple investigators have attempted to develop non-contact pulse oximeters, none of these devices have achieved accuracy sufficient for clinical use, no such devices have been approved by the Food and Drug Administration, and there are currently no such devices on the market in the United States. While these devices are typically able to measure the heart and respiratory rates with some accuracy,v the accurate calculation of oxygen saturation from the arterial pulse (SpO2) using a non-contact reflectance oximetry probe is complicated by the interference of ambient light, patient temperature changes, as well as the inherent limitations of the sensing devices currently utilized. Poh et al have been somewhat successful at calculating the heart rate from a video recording using independent component analysis. However, Poh's method does not calculate instantaneous rates and requires a facial recognition component to track the facial orientation in the image, is not capable of measuring respiratory rate, and relies primarily on analysis of reflected green light (which cannot be used for the calculation of oxygen saturation). Our work involves modifying a commercial off the shelf (COTS) 3-channel (red, green, blue) CCD (charge coupled device) or CMOS (complementary metal oxide semiconductor) camera in the form of a web cam to detect near infrared and infrared spectrum radiation and applying an algorithm based fast Fourier transformation (FFT) of individual red pixel intensity to detect motion and color changes. Because our algorithm analyzes the first derivative of red pixel intensity, a face-tracking component is unnecessary, and we are able to calculate the heart rate and the respiratory rate in real time.

Official Title
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Non Contact Measurement of Vital Signs

Conditions
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Hypoxia, Hypoxemia

Intervention / Treatment
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* Device: Non-Contact Oximetry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infant aged 0 - 12 months Receiving care at UVA Heart rate, respiratory rate, and oxygenation (SpO2) being monitored continuously Exclusion Criteria: Greater than 12 months of age Not receiving continuous monitoring of heart rate, respiratory rate, and oxygenation (SpO2) Intubated and/or mechanically ventilated History of retinopathy of prematurity Inability to directly visualize the child's head Family unwilling to consent Parents less than 18 years of age

Ages Eligible for Study
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Maximum Age: 12 Months

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Newborn Infants<br>0-12 months old Male or female Any ethnicity | Device: Non-Contact Oximetry<br>* Video Record subject when subjected to small amounts of near infrared light<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure oxygen saturation to be correlated with oxygen saturation calculated from the video recording | the pulse oximeter saturation will be used as the reference oximeter reading that will be used to validate the oxygen saturation calculated from the video recording | 6 hours maximum | 
| Measure heart rate to be correlated with heart rate calculated from the video recording | the pulse oximeter heart rate measurement will be used as the reference oximeter reading that will be used to validate the heart rate calculated from the video recording | 6 hours maximum | 
| Measure respiratory rate to be correlated with respiratory rate calculated from the video recording | the respiratory rate as recorded in the ventilator will be used to validate the respiratory rate calculated from the video recording | 6 hours maximum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-Contact Oximetry, video plethysmography, oxygen desaturation