Accuracy of BabySat V3 With Profound Hypoxia and Motion

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.

Study Overview

• Status: Completed
• Conditions: Hypoxia
• Intervention / Treatment: Device: BabySat V3

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94133
      • University California San Fransisco, Department of Anesthesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 47 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants in this study should be healthy, between 18 and 50 years of age and willing to participate in breathing studies with blood samples.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of accuracy during motion	Determine the accuracy during varying degrees of motion and oxygen saturation	During the oxygen desaturation assessment

Collaborators and Investigators

• Sponsor: Owlet Baby Care, Inc.
• Collaborators: University of California, San Francisco
• Investigators: Principal Investigator: John Feiner, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2022
• Primary Completion (Actual): July 15, 2022
• Study Completion (Actual): July 15, 2022

Study Registration Dates

• First Submitted: October 6, 2022
• First Submitted That Met QC Criteria: October 12, 2022
• First Posted (Actual): October 14, 2022

Study Record Updates

• Last Update Posted (Actual): October 14, 2022
• Last Update Submitted That Met QC Criteria: October 12, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: BICK-ACC-20220714

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No