Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-03-11 @ 8:33 AM
Study NCT ID:
NCT02287220
Status:
UNKNOWN
Last Update Posted:
2018-06-01
First Post:
2014-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non Contact Measurement of Vital Signs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-31', 'studyFirstSubmitDate': '2014-11-05', 'studyFirstSubmitQcDate': '2014-11-07', 'lastUpdatePostDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure oxygen saturation to be correlated with oxygen saturation calculated from the video recording', 'timeFrame': '6 hours maximum', 'description': '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'}, {'measure': 'Measure heart rate to be correlated with heart rate calculated from the video recording', 'timeFrame': '6 hours maximum', 'description': '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'}, {'measure': 'Measure respiratory rate to be correlated with respiratory rate calculated from the video recording', 'timeFrame': '6 hours maximum', 'description': 'the respiratory rate as recorded in the ventilator will be used to validate the respiratory rate calculated from the video recording'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Non-Contact Oximetry', 'video plethysmography', 'oxygen desaturation'], 'conditions': ['Hypoxemia', 'Hypoxia']}, 'referencesModule': {'references': [{'pmid': '22502577', 'type': 'BACKGROUND', 'citation': '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': '16133912', 'type': 'BACKGROUND', 'citation': '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': '20588929', 'type': 'BACKGROUND', 'citation': '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': '19104573', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Newborn infants that are prone to desaturation events', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Infant aged 0 - 12 months\n* Receiving care at UVA\n* Heart rate, respiratory rate, and oxygenation (SpO2) being monitored continuously\n\nExclusion Criteria:\n\n* Greater than 12 months of age\n* 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\n* Family unwilling to consent Parents less than 18 years of age"}, 'identificationModule': {'nctId': 'NCT02287220', 'briefTitle': 'Non Contact Measurement of Vital Signs', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Non Contact Measurement of Vital Signs', 'orgStudyIdInfo': {'id': '17492'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Newborn Infants', 'description': '0-12 months old Male or female Any ethnicity', 'interventionNames': ['Device: Non-Contact Oximetry']}], 'interventions': [{'name': 'Non-Contact Oximetry', 'type': 'DEVICE', 'description': 'Video Record subject when subjected to small amounts of near infrared light', 'armGroupLabels': ['Newborn Infants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22908-0710', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Keita Ikeda, PhD', 'role': 'CONTACT', 'email': 'keita.ikeda@virginia.edu', 'phone': '919-593-1174'}, {'name': 'Marcia E. Birk', 'role': 'CONTACT', 'email': 'meb2w@hscmail.mcc.virginia.edu', 'phone': '(434) 982-0230'}, {'name': 'Marcia E. Birk, RN CCRN', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Karen Fairchild, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alix Paget-Brown, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Amy Blackman, BSN', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'centralContacts': [{'name': 'Keita Ikeda, PhD', 'role': 'CONTACT', 'email': 'keita.ikeda@virginia.edu', 'phone': '9195931174'}, {'name': 'Marko S Todorovic', 'role': 'CONTACT', 'email': 'mst5t@virginia.edu', 'phone': '(434) 924-2438'}], 'overallOfficials': [{'name': 'Robert Thiele, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Anesthesiology', 'investigatorFullName': 'Robert Thiele, MD', 'investigatorAffiliation': 'University of Virginia'}}}}