Non Contact Measurement of Vital Signs

NCT02287220 | Unknown

• 1 other identifier: 17492
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypoxemia; Hypoxia

Keywords

Non-Contact Oximetry; video plethysmography; oxygen desaturation

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Newborn Infants

0-12 months old Male or female Any ethnicity

Device: Non-Contact Oximetry

Interventions

Non-Contact Oximetry DEVICE

Video Record subject when subjected to small amounts of near infrared light

Newborn Infants

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Newborn infants that are prone to desaturation events

You may qualify if:

• Infant aged 0 - 12 months
• Receiving care at UVA
• Heart rate, respiratory rate, and oxygenation (SpO2) being monitored continuously

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908-0710, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 22502577 BACKGROUND

• 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.

  PMID: 16133912 BACKGROUND

• 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.

  PMID: 20588929 BACKGROUND

• 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.

  PMID: 19104573 BACKGROUND

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Thiele, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keita Ikeda, PhD

CONTACT

9195931174; keita.ikeda@virginia.edu

Marko S Todorovic

CONTACT

(434) 924-2438; mst5t@virginia.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Anesthesiology

Study Record Dates

• First Submitted: November 5, 2014
• First Posted: November 10, 2014
• Study Start: November 1, 2014
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: June 1, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)