Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-28 @ 4:31 PM
Study NCT ID:
NCT01221961
Status:
TERMINATED
Last Update Posted:
2013-11-15
First Post:
2010-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Masimo Radical-7 Monitor a Useful Adjuvant During Major Spine Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'whyStopped': 'We completed the 62% of the cases, enough data to get a conclusion of the study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-13', 'studyFirstSubmitDate': '2010-10-15', 'studyFirstSubmitQcDate': '2010-10-15', 'lastUpdatePostDateStruct': {'date': '2013-11-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin value', 'timeFrame': '0-8 hours', 'description': 'During the time surgery last.'}], 'secondaryOutcomes': [{'measure': 'Blood transfusion', 'timeFrame': '0-8 hours', 'description': 'During the time surgery last.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Major spine surgery', 'Hemoglobin', 'Blood transfusion'], 'conditions': ['Major Spine Surgery Procedure']}, 'descriptionModule': {'briefSummary': "This is a study designed to compare the agreement of hemoglobin (Hb) measurements, documented at specific time points (the time a blood sample was obtained by the standard clinical care after physician/nurse orders it and, during that same time, the Hb value recorded by the Masimo Radical-7 monitor); recorded several times throughout patient's major spine surgery procedure (depending on how many times the physician/nurse orders the Hb value to be tested), between the standard clinical practice {intermittent measure of Hb \\[Cedar Sinai Medical Center (CSMC) Lab and outside lab) and Masimo radical-7 device (continuous, non-invasive Hb level measurements)\\*.", 'detailedDescription': '\\*See whether or not the hemoglobin values recorded at the same time matches between the standard clinical practice (CSMC Lab and outside Lab) and the Masimo device'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing major spine surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled to undergo multiple level spine surgery procedures\n* 18 - 80 years of age\n* American Society of Anesthesiologists (ASA) Class I - III adults of either sex\n* Pregnant women\n\nExclusion Criteria:\n\n* Patients with a perfusion index less than 1 or low confidence reading\n* Patients with nail polish and /or a nail deformity on a finger that would used for sensor placement\n* Patient undergoing cardio-pulmonary bypass'}, 'identificationModule': {'nctId': 'NCT01221961', 'briefTitle': 'Masimo Radical-7 Monitor a Useful Adjuvant During Major Spine Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'A Study to Determine the Agreement Between Masimo Monitor and Standard of Care', 'orgStudyIdInfo': {'id': 'Pro00021287'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Masimo Radical-7', 'type': 'DEVICE', 'description': 'The Masimo device will be placed on one finger of the patient. To see whether or not the hemoglobin values recorded at the same time matches between the standard clinical practice (CSMC Lab and outside Lab) and the Masimo device'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Ronald H Wender, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Masimo Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair of the anesthesia department', 'investigatorFullName': 'Ronald Wender', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}