Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2026-02-13 @ 9:23 AM
Study NCT ID:
NCT01583634
Status:
COMPLETED
Last Update Posted:
2014-10-03
First Post:
2012-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy of Oximeters With Hypoxia and Methemoglobin or Carboxyhemoglobin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-02', 'studyFirstSubmitDate': '2012-04-12', 'studyFirstSubmitQcDate': '2012-04-20', 'lastUpdatePostDateStruct': {'date': '2014-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Venous Oxygen Saturation Accuracy Verification against Co-Oximeter', 'timeFrame': 'approximately 1 hour'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'Accuracy of the oximeter.', 'detailedDescription': 'The conventional pulse oximeter has been a standard in clinical care for non-invasive hemodynamic monitoring, which only measures the arterial blood oxygenation. There are many clinical situations where tissue hypoxia may exist despite normal values obtained by conventional pulse oximeter. This can be cause by inadequate monitoring of oxygen demand (i.e. venous oxygen saturation) of the tissues.\n\nThe existing method for venous blood oxygenation monitored is either through an invasive fiber optic catheter, or intermittently by blood sampling and CO-oximetry. However, catheterization can be costly and can include inherent risks. Therefore, due to the inherent risks of catheterization, venous oximetry is limited only to those critically ill patients. The clinical application of venous oximetry is numerous, including severe sepsis and septic shock, severe trauma and hemorrhagic shock, and heart failure and cardiac arrest.\n\nMore complete information on patient hemodynamics can be provided by non-invasively monitoring of venous blood oxygenation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy volunteers between the ages of 21 and 49 years of either gender, and a range of skin tones', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers between the ages of 21 and 49 years of either gender\n\nExclusion Criteria:\n\n* smokers\n* pregnancy\n* any chronic medical condition including heart disease, hypertension, pulmonary disease, liver or kidney disease\n* obesity\n* evidence of abnormal neck vein anatomy'}, 'identificationModule': {'nctId': 'NCT01583634', 'briefTitle': 'Accuracy of Oximeters With Hypoxia and Methemoglobin or Carboxyhemoglobin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mespere Lifesciences Inc.'}, 'officialTitle': 'Accuracy of Oximeters With Hypoxia and Methemoglobin or Carboxyhemoglobin', 'orgStudyIdInfo': {'id': 'MLS STP-9100001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy volunteers', 'description': '9 subjects (male and female)', 'interventionNames': ['Device: Mespere Oximeter', 'Device: Radiometer OSM-3 Co-Oximeter']}], 'interventions': [{'name': 'Mespere Oximeter', 'type': 'DEVICE', 'description': 'Mespere oximeter provides non-invasive venous blood oxygen saturation.', 'armGroupLabels': ['Healthy volunteers']}, {'name': 'Radiometer OSM-3 Co-Oximeter', 'type': 'DEVICE', 'description': 'OSM-3, a Radiometer manufactured hemoximeter, is intended for the photometric determination of hemoglobin.', 'armGroupLabels': ['Healthy volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco, Induced Hypoxia Lab', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Philip E Bickler, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mespere Lifesciences Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}