Non Contact Measurement of Vital Signs

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.

Study Overview

• Status: Unknown
• Conditions: Hypoxia; Hypoxemia
• Intervention / Treatment: Device: Non-Contact Oximetry

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Keita Ikeda, PHD; Phone Number: 9195931174; Email: keita.ikeda@virginia.edu
• Study Contact Backup: Name: Marko S Todorovic; Phone Number: (434) 924-2438; Email: mst5t@virginia.edu

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908-0710
      • Recruiting
      • University of Virginia
      • Contact: Marcia E. Birk; Phone Number: (434) 982-0230; Email: meb2w@hscmail.mcc.virginia.edu
      • Sub-Investigator: Marcia E. Birk, RN CCRN
      • Sub-Investigator: Karen Fairchild, MD
      • Sub-Investigator: Alix Paget-Brown, MD
      • Sub-Investigator: Amy Blackman, BSN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Newborn infants that are prone to desaturation events

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Newborn Infants; 0-12 months old Male or female Any ethnicity	Device: Non-Contact Oximetry; Video Record subject when subjected to small amounts of near infrared light

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: Robert Thiele, MD, University of Virginia

Publications and helpful links

General Publications

• Sun Y, Papin C, Azorin-Peris V, Kalawsky R, Greenwald S, Hu S. Use of ambient light in remote photoplethysmographic systems: comparison between a high-performance camera and a low-cost webcam. J Biomed Opt. 2012 Mar;17(3):037005. doi: 10.1117/1.JBO.17.3.037005.
• Wieringa FP, Mastik F, van der Steen AF. Contactless multiple wavelength photoplethysmographic imaging: a first step toward "SpO2 camera" technology. Ann Biomed Eng. 2005 Aug;33(8):1034-41. doi: 10.1007/s10439-005-5763-2.
• Poh MZ, McDuff DJ, Picard RW. Non-contact, automated cardiac pulse measurements using video imaging and blind source separation. Opt Express. 2010 May 10;18(10):10762-74. doi: 10.1364/OE.18.010762.
• Verkruysse W, Svaasand LO, Nelson JS. Remote plethysmographic imaging using ambient light. Opt Express. 2008 Dec 22;16(26):21434-45. doi: 10.1364/oe.16.021434.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): November 1, 2019

Study Registration Dates

• First Submitted: November 5, 2014
• First Submitted That Met QC Criteria: November 7, 2014
• First Posted (Estimate): November 10, 2014

Study Record Updates

• Last Update Posted (Actual): June 1, 2018
• Last Update Submitted That Met QC Criteria: May 31, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Non-Contact Oximetry; video plethysmography; oxygen desaturation
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: 17492

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No