Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-27 @ 8:16 AM
Study NCT ID:
NCT01604668
Status:
COMPLETED
Last Update Posted:
2013-08-21
First Post:
2012-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Accuracy of Three Versions of Non-Invasive Hemoglobin Monitoring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-19', 'studyFirstSubmitDate': '2012-05-18', 'studyFirstSubmitQcDate': '2012-05-23', 'lastUpdatePostDateStruct': {'date': '2013-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of hemoglobin levels derived by sensor RevF versus sensor RevG versus a hemoglobin derived from a blood sample. A baseline hemoglobin level will be taken from the Pronto-7 hand-held hemoglobin device prior to surgery.', 'timeFrame': 'Two or more measurements during surgery', 'description': 'Comparison of hemoglobin levels derived by sensor RevF versus sensor RevG versus a hemoglobin derived from a blood sample. A baseline hemoglobin level will be taken from the Pronto-7 hand-held hemoglobin device prior to surgery.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Blood Loss']}, 'referencesModule': {'references': [{'pmid': '21385985', 'type': 'BACKGROUND', 'citation': 'Miller RD, Ward TA, Shiboski SC, Cohen NH. A comparison of three methods of hemoglobin monitoring in patients undergoing spine surgery. Anesth Analg. 2011 Apr;112(4):858-63. doi: 10.1213/ANE.0b013e31820eecd1. Epub 2011 Mar 8.'}]}, 'descriptionModule': {'briefSummary': 'There is no study hypothesis. The purpose of this study is to compare the accuracy of the: 1) SpHb (Radical 7 Pulse Co-Oximetry with SpHb™) RevF sensor (currently marketed), 2) the SpHb RevG sensor (a new, limited release version), and 3) the Pronto-7 sensor (currently marketed version) in patients undergoing spine surgery.', 'detailedDescription': "The purpose of this study is to compare the accuracy of the: 1) SpHb RevF sensor (currently marketed), 2) the SpHb RevG sensor (a new, limited release version), and 3) the Pronto-7 sensor (currently marketed version) in patients undergoing spine surgery. The results from the three sensors will be compared to a blood hemoglobin level taken intermittently (as a function of the patient's anesthesia care) and analyzed in the UCSF Clinical Laboratories.\n\nThis is an observational study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing spine surgery', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ≥ 18 years of age\n* ASA Classification 1, 2 or 3\n* Scheduled to undergo spine surgery\n\nExclusion Criteria:\n\n* Pregnant of nursing\n* In the investigator's judgement would not be suitable for research"}, 'identificationModule': {'nctId': 'NCT01604668', 'briefTitle': 'Comparative Accuracy of Three Versions of Non-Invasive Hemoglobin Monitoring', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Comparative Accuracy of Three Versions of Non-Invasive Hemoglobin Monitoring.', 'orgStudyIdInfo': {'id': '1000524C'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'RevF vs RevG vs Pronto-7', 'description': 'Comparison of hemoglobin levels derived by continuous hemoglobin sensor RevF versus continuous hemoglobin sensor RevG versus an intermittent hemoglobin level derived from the Pronto-7 hand-held device versus a hemoglobin derived from a blood sample.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco Moffitt/Long Hospitals', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Ronald D. Miller, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}