Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2026-01-05 @ 6:07 PM
Study NCT ID:
NCT02475668
Status:
COMPLETED
Last Update Posted:
2015-07-10
First Post:
2015-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SpO2 Accuracy Validation of Pulse Oximetry Systems During Motion and Non-Motion Conditions
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': 'ACTUAL', 'count': 13}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-09', 'studyFirstSubmitDate': '2015-06-16', 'studyFirstSubmitQcDate': '2015-06-16', 'lastUpdatePostDateStruct': {'date': '2015-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'accuracy value (Arms) for %SpO2 over the range of 70-100% in motion and non-motion', 'timeFrame': '3 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypoxia']}, 'descriptionModule': {'briefSummary': 'Study to evaluate the %SpO2 accuracy performance of the Nonin Medical pulse oximetry systems.', 'detailedDescription': 'Study to evaluate the %SpO2 accuracy performance of the Nonin Medical pulse oximetry systems during motion and non-motion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The subject is male or female\n* The subject is of any racial or ethnic group\n* The subject is \\> 30 kg (\\>66 pounds) in weight (self-reported)\n* The subject has at least one finger height of 0.2 - 1.0 inch (based on measurement)\n* The subject is between 18 years and 45 years of age (self=reported)\n* The subject shows no evidence of medical problems as indicated by satisfactory completion of the health assessment form\n* The subject has given written informed consent to participate in the study\n* The subject is both willing and able to comply with study procedures.\n\nExclusion Criteria:\n\n* The subject has a BMI greater than 31 (based on weight and height)\n* The subject has had any relevant injury at the sensor location site (self-reported)\n* The subject has deformities or abnormalities that may prevent proper application of the device under test (based on examination)\n* The subject is current smoker (self-reported)\n* The subject has a known respiratory condition (self-reported)\n* The subject has a known heart or cardiovascular condition (self-reported)\n* The subject is currently pregnant (self-reported)\n* The subject is actively trying to get pregnant (self-reported)\n* The subject has a clotting disorder (self-reported)\n* The subject has Raynaud's Disease (self-reported)\n* The subject is known to have a hemoglobinopathy (self-reported)\n* The subject is on blood thinners or medication with aspirin (self-reported)\n* The subject has unacceptable collateral circulation from the ulnar artery (based on examination)\n* The subject is unwilling or unable to provide written informed consent to participate in the study\n* The subject is unwilling or unable to comply with the study procedures\n* The subject has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing."}, 'identificationModule': {'nctId': 'NCT02475668', 'briefTitle': 'SpO2 Accuracy Validation of Pulse Oximetry Systems During Motion and Non-Motion Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nonin Medical, Inc'}, 'officialTitle': 'SpO2 Accuracy Validation of Pulse Oximetry Systems During Motion and Non-Motion Conditions of Induced Hypoxia as Compared to Arterial Blood CO-Oximetry', 'orgStudyIdInfo': {'id': 'QATP2759'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pulse oximeter', 'type': 'DEVICE', 'description': 'Hypoxia'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80027', 'city': 'Louisville', 'state': 'Colorado', 'country': 'United States', 'facility': 'Clinimark', 'geoPoint': {'lat': 39.97776, 'lon': -105.13193}}], 'overallOfficials': [{'name': 'Dave Ransom, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Avista Adventis Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nonin Medical, Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Clinimark, LLC', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}