Accuracy of Owlet Smart Sock Sensor 3rd Generation With Profound Hypoxia
Overview
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.
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: March 13, 2020
Interventions
- Diagnostic Test: Owlet Smart Sock Sensor 3rd Generation
- Pulse Oximetry
Clinical Trial Outcome Measures
Primary Measures
- SpO2 Accuracy (Arms) of ≤3 Between 70 and 100%
- Time Frame: 1 hour
- Determination of Average Root Mean Square SpO2 Accuracy of the Owlet Smart Sock 3rd Generation
Participating in This Clinical Trial
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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 49 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Owlet Baby Care, Inc.
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Philip Bickler, MD, Principal Investigator, UCSF Department of Anesthesia
- John Feiner, MD, Principal Investigator, UCSF Department of Anesthesia
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.