Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-01-24 @ 7:39 AM
Study NCT ID:
NCT03125005
Status:
COMPLETED
Last Update Posted:
2017-07-27
First Post:
2017-04-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Accuracy of Methemoglobin Measurement for Rainbow Universal Pulse Oximeter Sensor
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': 'Rainbow Universal Pulse Oximeter Sensor', 'description': 'All subjects will be enrolled in the test group and will receive Rainbow Universal Pulse Oximeter Sensor.\n\nRainbow Universal Pulse Oximeter Sensor', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 0, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Accuracy of Sensor by Arms Calculation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rainbow Universal Pulse Oximeter Sensor', 'description': 'All subjects will be enrolled in the test group and will receive Rainbow Universal Pulse Oximeter Sensor.\n\nRainbow Universal Pulse Oximeter Sensor'}], 'classes': [{'categories': [{'measurements': [{'value': '0.63', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 hours', 'description': 'Accuracy willl be determined by comparing the noninvasive blood methemoglobin measurement (expressed as a percentage of total hemoglobin) of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.', 'unitOfMeasure': 'Percentage of total hemoglobin', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rainbow Universal Pulse Oximeter Sensor', 'description': 'All subjects will be enrolled in the test group and will receive Rainbow Universal Pulse Oximeter Sensor.\n\nRainbow Universal Pulse Oximeter Sensor'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Rainbow Universal Pulse Oximeter Sensor', 'description': 'All subjects will be enrolled in the test group and will receive Rainbow Universal Pulse Oximeter Sensor.\n\nRainbow Universal Pulse Oximeter Sensor'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '51', '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': '29', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '51', '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': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2012-06-21', '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': '2012-06-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of Sensor by Arms Calculation', 'timeFrame': '5 hours', 'description': 'Accuracy willl be determined by comparing the noninvasive blood methemoglobin measurement (expressed as a percentage of total hemoglobin) of the pulse oximeter to that 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 level of methemoglobin (HbMet) will be increased in a controlled manner by administering sodium nitrite intravenously in healthy volunteers. The accuracy of a noninvasive HbMet sensor will be assessed by comparison to blood measurements from a laboratory analyzer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria\n\n* The subject is male or female, aged ≥18 and \\<50.\n* The subject is in good general health with no evidence of any medical problems.\n* The subject is fluent in both written and spoken English.\n* The subject has provided informed consent and is willing to comply with the study procedures.\n\nExclusion Criteria:\n\n* The subject is obese (BMI\\>30).\n* The subject has a known history of heart disease, lung disease, kidney or liver disease.\n* Diagnosis of asthma, sleep apnea, or use of CPAP.\n* Subject has diabetes.\n* Subject has a clotting disorder.\n* The subject has a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation.\n* The subject has any other serious systemic illness.\n* The subject is a current smoker.\n* Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.\n* The subject has a history of fainting or vasovagal response.\n* The subject has a history of sensitivity to local anesthesia or allergy to the study drugs.\n* The subject has a diagnosis of Raynaud's disease.\n* The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).\n* The subject is pregnant, lactating or trying to get pregnant.\n* The subject has a history of migraine headaches.\n* The subject is currently taking antidepressants.\n* The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.\n* The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study."}, 'identificationModule': {'nctId': 'NCT03125005', 'briefTitle': 'Accuracy of Methemoglobin Measurement for Rainbow Universal Pulse Oximeter Sensor', 'organization': {'class': 'INDUSTRY', 'fullName': 'Masimo Corporation'}, 'orgStudyIdInfo': {'id': 'TR22640-BICK0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rainbow Universal Pulse Oximeter Sensor', 'description': 'All subjects will be enrolled in the test group and will receive Rainbow Universal Pulse Oximeter Sensor.', 'interventionNames': ['Device: Rainbow Universal Pulse Oximeter Sensor']}], 'interventions': [{'name': 'Rainbow Universal Pulse Oximeter Sensor', 'type': 'DEVICE', 'armGroupLabels': ['Rainbow Universal Pulse Oximeter Sensor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92618', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Masimo Clinical Lab', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '94117', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masimo Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}