Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2026-02-21 @ 7:05 AM
Study NCT ID:
NCT03030833
Status:
COMPLETED
Last Update Posted:
2017-09-01
First Post:
2017-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dysfunctional Hemoglobin Pulse Oximetry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002249', 'term': 'Carbon Monoxide Poisoning'}], 'ancestors': [{'id': 'D005739', 'term': 'Gas Poisoning'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-31', 'studyFirstSubmitDate': '2017-01-23', 'studyFirstSubmitQcDate': '2017-01-23', 'lastUpdatePostDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Carboxyhemoglobin accuracy', 'timeFrame': 'Through study completion, an average of 3 months.', 'description': 'Values from the test device will be compared to the values from co-oximetry to determine accuracy of the test device.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Carbon Monoxide Poisoning']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess device performance in the presence of carbon monoxide.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy male and females.', '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 between 18 years and 50 years of age (self-reported).\n* The subject does not have significant medical problems (self-reported).\n* The subject is willing to provide written informed consent and is willing and able to comply with study procedures.\n* Exclusion Criteria:\n* Has a BMI greater than 30.0 (calculated from self-reported weight and height).\n* Has had any relevant injury at the sensor location site (self-reported).\n* Has a deformity or abnormalities that may prevent proper application of the device under test (based on visual inspection).\n* Has a known respiratory condition (self-reported).\n* Is currently a smoker (self-reported).\n* Has a known heart or cardiovascular condition (self-reported).\n* Is currently pregnant (positive serum pregnancy test at screening visit or positive urine POC test on day of study).\n* Is female and actively trying to get pregnant (self-reported).\n* Has a clotting disorder (self-reported).\n* Has Raynaud's Disease (self-reported).\n* Is known to have anemia (hemoglobin value below lower range of normal for gender)\n* Is known to have a hemoglobinopathy such as sickle-cell anemia or thalassemia (abnormal hemoglobin electrophoresis).\n* Is known to have a inherited or congenital methemoglobinemia (self-reported).\n* Has unacceptable collateral circulation from the ulnar artery (based on exam).\n* Is unwilling or unable to provide written informed consent to participate in the study.\n* Has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing."}, 'identificationModule': {'nctId': 'NCT03030833', 'briefTitle': 'Dysfunctional Hemoglobin Pulse Oximetry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nonin Medical, Inc'}, 'officialTitle': 'Dysfunctional Hemoglobin Pulse Oximeter', 'orgStudyIdInfo': {'id': 'QATP3040'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pulse Oximeter', 'type': 'DEVICE', 'description': 'Comparison of pulse oximetry to blood gas analyzer.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'HPPL Duke Univeristy', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'David B MacLeod, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nonin Medical, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}