Hypoxia Clinical Trial
Official title:
Accuracy of BabySat V3 With Profound Hypoxia and Motion
Verified date | October 2022 |
Source | Owlet Baby Care, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | July 15, 2022 |
Est. primary completion date | July 15, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 49 Years |
Eligibility | Inclusion Criteria: - The subject is male or female, aged =18 and <50 - The subject is in good general health with no evidence of any medical problems - The subject is fluent in both written and spoken English - The subject has provided informed consent and is willing to comply with the study procedures Exclusion Criteria: - The subject is obese (BMI>30). - The subject has a known history of heart disease, lung disease, kidney or liver disease. - Diagnosis of asthma, sleep apnea, or use of CPAP. - Subject has diabetes. - Subject has a clotting disorder. - 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. - The subject has any other serious systemic illness. - The subject is a current smoker. - Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly. - The subject has a history of fainting or vasovagal response. - The subject has a history of sensitivity to local anesthesia. - The subject has a diagnosis of Raynaud's disease. - The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test). - The subject is pregnant, lactating or trying to get pregnant. - The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures. - The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study. |
Country | Name | City | State |
---|---|---|---|
United States | University California San Fransisco, Department of Anesthesia | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Owlet Baby Care, Inc. | University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of accuracy during motion | Determine the accuracy during varying degrees of motion and oxygen saturation | During the oxygen desaturation assessment |
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