Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2026-01-06 @ 8:12 AM
Study NCT ID:
NCT03124758
Status:
COMPLETED
Last Update Posted:
2017-07-27
First Post:
2017-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Accuracy of Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'studies@masimo.com', 'title': 'Tala Harake', 'organization': 'Masimo'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Noninvasive Hemoglobin Sensor', 'description': 'All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP)', 'otherNumAtRisk': 354, 'otherNumAffected': 0, 'seriousNumAtRisk': 354, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Accuracy of Sensor by Arms Calculation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}]}, {'units': 'data points', 'counts': [{'value': '1990', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Noninvasive Hemoglobin Sensor', 'description': 'All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1-5 hours', 'description': 'Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.', 'unitOfMeasure': 'g/dL', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'data points', 'denomUnitsSelected': 'data points'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Noninvasive Hemoglobin Sensor', 'description': 'All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '354'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '354'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Noninvasive Hemoglobin Sensor', 'description': 'All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP)'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '354', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '127', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '227', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 354}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2011-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-28', 'studyFirstSubmitDate': '2017-04-14', 'resultsFirstSubmitDate': '2017-05-08', 'studyFirstSubmitQcDate': '2017-04-20', 'lastUpdatePostDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-08', 'studyFirstPostDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of Sensor by Arms Calculation', 'timeFrame': '1-5 hours', 'description': 'Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'In this study, the accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory hematology analyzer. Blood samples are collected from healthy volunteers who are enrolled in either a blood draw procedure or a hemodilution procedure wherein blood is repeatedly sampled as the concentration of hemoglobin is reduced in a controlled manner by administering fluids intravenously.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'A. Hemodilution Test Procedure\n\nInclusion Criteria:\n\n* Weight of more than 110 lbs and less than 220 lbs.\n* Physical status of ASA I of II\n* Able to read and communicate in English\n* Has signed written informed consent\n* Female, non pregnant. Female subjects will be provided with a pregnancy test free of charge.\n\nExclusion Criteria\n\n* Age less than 18 yrs and greater than 35 years\n* Weight of less than 110 lbs or more than 220 lbs.\n* Hemoglobin less than 12 g/dL\n* ASA physical status of III. IV, V.\n* Pregnant\n* Subject has known drug or alcohol abuse\n* Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails.\n* Subject has experienced a head injury with loss of consciousness within the last year\n* Subject has known neurological and psychiatric disorder that interferes with the subjects level of consciousness\n* Known or concurrent chronic usage of psychoactive or anticonvulsive drugs within the last 90 days, or any use in the last 7 day (i.e. tricyclic antidepressants, MAO inhibitors, Lithum, neuroleptics, anxiolytics or antipsychotics, except SSRIs).\n* Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this study, such as Reynauds Syndrome.\n* Hypertension: Systolic BP \\>140 mmHg or Diastolic BP \\> 90 mmHg.\n* Baseline heart rate \\< 50 bpm.\n* Inability to tolerate sitting still or minimal movement for up to 90 minutes\n* Discretion of investigator\n\nB. Blood Draw Test Procedure\n\nInclusion Criteria:\n\n-Subjects must understand and consent to be in the study.\n\nExclusion Criteria\n\n* Subjects less than 18 years of age.\n* Subjects who do not understand the study and the risks involved.\n* Anyone deemed ineligible by test personnel.'}, 'identificationModule': {'nctId': 'NCT03124758', 'briefTitle': 'Accuracy of Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Masimo Corporation'}, 'orgStudyIdInfo': {'id': 'TR24577-TP15879-TP14065'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Noninvasive Hemoglobin Sensor', 'description': 'All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP)', 'interventionNames': ['Device: Hemoglobin Sensor ((Rainbow Reusable DCI, DCIP))']}], 'interventions': [{'name': 'Hemoglobin Sensor ((Rainbow Reusable DCI, DCIP))', 'type': 'DEVICE', 'description': 'Measurement of Noninvasive Hemoglobin (SpHb)', 'armGroupLabels': ['Noninvasive Hemoglobin Sensor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92618', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Masimo Corporation', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masimo Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}