Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-01-23 @ 4:16 PM
Study NCT ID:
NCT01747460
Status:
COMPLETED
Last Update Posted:
2013-12-06
First Post:
2012-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulse Oximetry_Performance Testing- PCBA-1 (Printed Circuit Board Assembly)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-05', 'studyFirstSubmitDate': '2012-11-27', 'studyFirstSubmitQcDate': '2012-12-10', 'lastUpdatePostDateStruct': {'date': '2013-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SpO2 Accuracy (percentage of blood oxygen saturation)', 'timeFrame': 'Duration of subject visit- approx. 1.5 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Subjects'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'To determine accuracy specifications of the Pulse oximeter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy Subjects', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female subjects between the ages of 18 to 50 years (inclusive).\n2. Must undergo a physical examination by a licensed physician, advanced practice nurse or physician assistant, including a 12 lead ECG, a medical history, and a blood test checking complete blood count and screening for sickle cell trait or disease\n3. All female volunteers must have a negative urine pregnancy test prior to participation.\n\nExclusion Criteria:\n\n1. Pregnancy or lactating women\n2. Unexplained syncopal episodes\n3. Hypertension (defined as a systolic pressure of \\>145 mmHg or a diastolic pressure \\>90 mm Hg on three consecutive readings)\n4. Premature ventricular contractions (PVC\'s) that are symptomatic or occur at a rate of more than 5/minute\n5. History of seizures (except childhood febrile seizures) or epilepsy\n6. Routine use of tranquilizers and/or excessive anxiety\n7. History of frequent headaches or migraines\n8. History of stroke\n9. Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect our ability to test multiple sensors\n10. History of "altitude sickness" defined as headaches, malaise or dizziness when in the mountains or in an aircraft at altitude significantly above sea level for a prolonged period of time (\\> 1 hour)\n11. History of significant respiratory disease, such as severe asthma, emphysema, etc.\n12. Sickle cell disease or trait.\n13. The use of medications, pre-existing medical conditions, treatment for a medical condition or any other reason deemed relevant by the clinician conducting the study.\n14. Abnormal ECG finding\n15. Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain)\n16. Prior or known allergies to heparin.\n17. History of transient ischemic attacks or carotid artery disease\n18. History of myocardial ischemia, angina, myocardial infarction, congestive heart failure or cardiomyopathy\n19. History of chronic renal impairment\n20. History of recent arterial cannulation (less than 1 month prior to study)\n21. History of complications from previous arterial cannulation\n22. Current use of blood thinners'}, 'identificationModule': {'nctId': 'NCT01747460', 'briefTitle': 'Pulse Oximetry_Performance Testing- PCBA-1 (Printed Circuit Board Assembly)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic - MITG'}, 'officialTitle': 'Controlled Acute Hypoxia Studies Using a Bedside Respiratory Patient Monitoring System With the Functional Patient Monitoring PCBA-1', 'orgStudyIdInfo': {'id': 'COVMOPR0250'}}, 'contactsLocationsModule': {'locations': [{'zip': '80301', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'Covidien', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic - MITG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}