Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 3:39 AM
Study NCT ID:
NCT05581394
Status:
COMPLETED
Last Update Posted:
2022-10-14
First Post:
2022-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy of BabySat V3 With Profound Hypoxia and Motion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-12', 'studyFirstSubmitDate': '2022-10-06', 'studyFirstSubmitQcDate': '2022-10-12', 'lastUpdatePostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of accuracy during motion', 'timeFrame': 'During the oxygen desaturation assessment', 'description': 'Determine the accuracy during varying degrees of motion and oxygen saturation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypoxia']}, 'descriptionModule': {'briefSummary': 'Performance testing of pulse oximeters. The protocol involves brief stable arterial oxygen desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia has been attained and during different motion scenarios. The blood sample is analyzed for oxygen saturation with a gold standard bench CO-oximeter. This protocol is aligned with the latest ISO and FDA guidance documents for pulse oximeter testing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants in this study should be healthy, between 18 and 50 years of age and willing to participate in breathing studies with blood samples.', '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 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.\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 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': 'NCT05581394', 'briefTitle': 'Accuracy of BabySat V3 With Profound Hypoxia and Motion', 'organization': {'class': 'INDUSTRY', 'fullName': 'Owlet Baby Care, Inc.'}, 'officialTitle': 'Accuracy of BabySat V3 With Profound Hypoxia and Motion', 'orgStudyIdInfo': {'id': 'BICK-ACC-20220714'}}, 'armsInterventionsModule': {'interventions': [{'name': 'BabySat V3', 'type': 'DEVICE', 'description': 'Evaluation of Accuracy of BabySat V3'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94133', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University California San Fransisco, Department of Anesthesia', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'John Feiner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Owlet Baby Care, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of California, San Francisco', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}