Accuracy of BabySat V3 With Profound Hypoxia and Motion

Sponsor

Owlet Baby Care, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT05581394

Collaborator

University of California, San Francisco (Other)

Enrollment

Location

Actual Duration (Days)

365.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypoxia	Device: BabySat V3

Study Design

Study Type:

Observational

Actual Enrollment :

12 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Accuracy of BabySat V3 With Profound Hypoxia and Motion

Actual Study Start Date :

Jul 14, 2022

Actual Primary Completion Date :

Jul 15, 2022

Actual Study Completion Date :

Jul 15, 2022

Outcome Measures

Primary Outcome Measures

Evaluation of accuracy during motion [During the oxygen desaturation assessment]
Determine the accuracy during varying degrees of motion and oxygen saturation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 49 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University California San Fransisco, Department of Anesthesia	San Francisco	California	United States	94133

Sponsors and Collaborators

Owlet Baby Care, Inc.
University of California, San Francisco

Investigators

Principal Investigator: John Feiner, MD, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Owlet Baby Care, Inc.

ClinicalTrials.gov Identifier:

NCT05581394

Other Study ID Numbers:

BICK-ACC-20220714

First Posted:

Oct 14, 2022

Last Update Posted:

Oct 14, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypoxia

Study Results

No Results Posted as of Oct 14, 2022