Accuracy of BabySat V3 With Profound Hypoxia and Motion

NCT05581394 | Completed

• 1 other identifier: BICK-ACC-20220714
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypoxia

Outcome Measures

Primary Outcomes (1)

• Evaluation of accuracy during motion

  Determine the accuracy during varying degrees of motion and oxygen saturation

  During the oxygen desaturation assessment

Interventions

BabySat V3 DEVICE

Evaluation of Accuracy of BabySat V3

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Owlet Baby Care, Inc.: lead
• University of California, San Francisco: collaborator

Study Sites (1)

University California San Fransisco, Department of Anesthesia

San Francisco, California, 94133, United States

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• John Feiner, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: October 14, 2022
• Study Start: July 14, 2022
• Primary Completion: July 15, 2022
• Study Completion: July 15, 2022
• Last Updated: October 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)