Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-02-10 @ 7:21 PM
Study NCT ID:
NCT01997502
Status:
COMPLETED
Last Update Posted:
2025-04-09
First Post:
2013-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy of Pulse CO-Oximetry Technology in Characterizing Noninvasive SpHb
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 621}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2013-11-01', 'studyFirstSubmitQcDate': '2013-11-21', 'lastUpdatePostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of Masimo Rainbow technology to arterial blood samples taken during surgery', 'timeFrame': 'Five year', 'description': 'Correlation between standard, lab-based, hemoglobin measurement and concurrent SpHb.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Hemoglobin', 'Non-invasive'], 'conditions': ['Surgery', 'Hemoglobin']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://studypages.com/s/a-study-of-the-accuracy-of-experimental-pulse-co-oximetry-technology-for-noninvasive-hemoglobin-sphb-measurements-766867/', 'label': 'Learn more or sign up for the study here!'}]}, 'descriptionModule': {'briefSummary': "This protocol is a request from Masimo to assist in the collection of data to be used to further refine the accuracy of the monitor's algorithm.", 'detailedDescription': "The specific aim of this study is to collect data to characterize Masimo's noninvasive Rainbow SpHb technology during surgeries. The purpose is to compare Masimo Rainbow technology to arterial blood samples taken during surgery. Hemoglobin concentrations in the arterial blood samples will be measured using standard blood analyzers on site and/or the sponsor's laboratory."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients scheduled for elective surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for elective surgery requiring intra-arterial pressure monitoring\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Pregnancy\n* Prisoners'}, 'identificationModule': {'nctId': 'NCT01997502', 'briefTitle': 'Accuracy of Pulse CO-Oximetry Technology in Characterizing Noninvasive SpHb', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Prospective Observational Study Characterizing Noninvasive Hemoglobin (SpHb) Measured With Pulse CO-Oximetry Technology in a Variety of Surgical Cases', 'orgStudyIdInfo': {'id': '494171'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pulse CO-Oximetry Technology', 'type': 'DEVICE', 'description': 'In addition to the standard pulse oximeter used for clinical care, up to six SpHb finger sensors will be applied to the patient. Additional sensors may also be applied to the forehead, neck, chest and ears.\n\nMasimo FDA cleared pulse CO-Oximeter devices: Radical-7, Rad-87, Rad-57, Pronto, Pronto-7, for the noninvasive measurement of SpO2, PR, PI, PVI, SpCO, SpMet, and SpHb, total hemoglobin and respiratory rate.\n\nNo treatment decisions will be made based on the new technology and no extra medical procedures are required for the study.'}, {'name': 'Blood draw', 'type': 'OTHER', 'description': '4mL arterial blood samples (up to 1 per hour), outside standard of care, are drawn throughout the surgical procedure and sent to UCDMC lab/Masimo lab for analysis.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Health', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Neal Fleming, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor, Director, Cardiovascular and Thoracic Anesthesiology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}