Recruiting

Vital Signs Measurement

Sponsor:

University of Virginia

Code:

NCT02287220

Conditions

Hypoxemia

Hypoxia

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

Non-Contact Oximetry

Study Details

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

Study ID

NCT02287220

Start date

Nov, 2014

Status verified date

May, 2018

Completion date

Nov, 2019

Anticipated

Primary completion date

Nov, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

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 Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

Newborn Infants

0-12 months old Male or female Any ethnicity

Interventions

Non-Contact Oximetry

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

Primary outcome measure

  • Measure oxygen saturation to be correlated with oxygen saturation calculated from the video recording [ Time Frame: 6 hours maximum ]
  • Measure heart rate to be correlated with heart rate calculated from the video recording [ Time Frame: 6 hours maximum ]
  • Measure respiratory rate to be correlated with respiratory rate calculated from the video recording [ Time Frame: 6 hours maximum ]

Central Contacts and Locations

Central contacts

Keita Ikeda, PhD

9195931174keita.ikeda@virginia.edu

Marko S Todorovic

(434) 924-2438mst5t@virginia.edu

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908-0710

Contacts

Keita Ikeda, PhD

919-593-1174keita.ikeda@virginia.edu

Marcia E. Birk

(434) 982-0230meb2w@hscmail.mcc.virginia.edu

More Information

Sponsor

University of Virginia

Last update posted

Jun 1, 2018

Last verified

May, 2018

Keywords

  • Non-Contact Oximetry
  • video plethysmography
  • oxygen desaturation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2018-06-01.