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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05581394
Other study ID # BICK-ACC-20220714
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 14, 2022
Est. completion date July 15, 2022

Study information

Verified date October 2022
Source Owlet Baby Care, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date July 15, 2022
Est. primary completion date July 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 49 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
BabySat V3
Evaluation of Accuracy of BabySat V3

Locations

Country Name City State
United States University California San Fransisco, Department of Anesthesia San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
Owlet Baby Care, Inc. University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of accuracy during motion Determine the accuracy during varying degrees of motion and oxygen saturation During the oxygen desaturation assessment
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