Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2025-12-27 @ 12:16 PM
Study NCT ID:
NCT03124966
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 Hemoglobin Measurement for Various Rainbow Pulse Oximeter Sensors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicalresearchdept@masimo.com', 'title': 'Vikram Ramakanth', 'organization': 'Masimo'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Noninvasive Hemoglobin Sensor', 'description': 'All subjects are enrolled into the test group and all will receive the pulse oximeter sensor.', 'otherNumAtRisk': 118, 'deathsNumAtRisk': 118, 'otherNumAffected': 0, 'seriousNumAtRisk': 118, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Accuracy of Sensor by Arms Calculation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Noninvasive Hemoglobin Sensor', 'description': 'All subjects are enrolled into the test group and all will receive the pulse oximeter sensor.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.96', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1-3 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'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Noninvasive Hemoglobin Sensor', 'description': 'All subjects are enrolled into the test group and all will receive the pulse oximeter sensor.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '118'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '118'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Noninvasive Hemoglobin Sensor', 'description': 'All subjects are enrolled into the test group and all will receive the pulse oximeter sensor.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '118', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '78', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '118', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2009-12-31', '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': '2009-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of Sensor by Arms Calculation', 'timeFrame': '1-3 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': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': "In this study, the concentration of hemoglobin within the subject's blood will be reduced in a controlled manner by administering fluids intravenously. The accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory analyzer."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Study Site 1:\n\nInclusion Criteria:\n\n* Has physical status between ASA 1 or 2\n* Able to communicate in English\n\nExclusion Criteria:\n\n* Pregnant or sexually active without birth control.\n* Hemoglobin less than 11g/dL\n* Known alcohol or drug abuse\n* Skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection\n* Nail polish\n* Head injury with loss of consciousness within the last year\n* Known neurological and psychiatric conditions.\n* Known concurrent chronic usage of psychoactive or anti-convulsive drugs within the last 90 days, or use in the last 7 days (i.e. tricyclic antidepressants, MAO inhibitors, lithium, neuroleptics, anxiolytics or antipsychotics. Except SSRIs\n* Subject has any medical condition which, in the judgement of the investigator, renders them inappropriate for participation in this study, such as Raynaud's syndrome\n* Hypertension: Systolic BP \\>= 140 mmHg or Diastolic BP \\>= 90 mmHg\n* Baseline heart rate \\<50 beats per minute\n\nStudy Site 2:\n\nInclusion Criteria:\n\n* Male or female\n* 18-35 years of age\n* Physical status of ASA I or II\n* Able to read and communicate in English\n* Has signed written informed consent\n* If female, non pregnant. If female subject is currently sexually active and not on birth control they must have a negative pregnancy test prior to study enrollment.\n\nExclusion Criteria\n\n* Age less than 18 yrs and greater than 35 years\n* Hemoglobin less than 12 g/dL\n* ASA physical status of III, IV, or V\n* Pregnant or sexually active without birth control\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, lithium, 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 Raynauds 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"}, 'identificationModule': {'nctId': 'NCT03124966', 'briefTitle': 'Accuracy of Hemoglobin Measurement for Various Rainbow Pulse Oximeter Sensors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Masimo Corporation'}, 'orgStudyIdInfo': {'id': 'TR19443-56044'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Noninvasive Hemoglobin Sensor', 'description': 'All subjects are enrolled into the test group and all will receive the pulse oximeter sensor.', 'interventionNames': ['Device: Pulse Oximeter sensor']}], 'interventions': [{'name': 'Pulse Oximeter sensor', 'type': 'DEVICE', 'armGroupLabels': ['Noninvasive Hemoglobin Sensor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92618', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Masimo Clinical Lab', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Medical Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masimo Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}