Accuracy of Owlet Smart Sock Sensor 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.

Full Title of Study: “Accuracy of Owlet Smart Sock 3rd Generation With Profound Hypoxia”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 13, 2020

Clinical Trial Outcome Measures

Primary 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

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

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