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OpenTrials
Completed

NCT Number: NCT04446247

Accuracy of Owlet Smart Sock Sensor 3rd Generation With Profound Hypoxia

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.

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Key information

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University California San Fransisco, Department of Anesthesia

San Francisco, California, 94133, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Owlet Smart Sock Sensor 3rd Generation

Diagnostic Test

Pulse Oximetry

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Owlet Baby Care, Inc.

Industry

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 24, 2020
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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