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. 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.
Full Title of Study: “Accuracy of Owlet Smart Sock 3rd Generation With Profound Hypoxia”
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: March 13, 2020
Clinical Trial Outcome Measures
- SpO2 Accuracy (Arms) of ≤3 between 70 & 100%
- Time Frame: 1 hour
- Determination of SpO2 Accuracy of the Owlet Smart Sock 3rd Generation
Participating in This Clinical Trial
- 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.
- 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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 49 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Owlet Baby Care, Inc.
- Provider of Information About this Clinical Study
- Overall Official(s)
- Philip Bickler, MD, Principal Investigator, UCSF Department of Anesthesia
- John Feiner, MD, Principal Investigator, UCSF Department of Anesthesia
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