Clinical trial NCT05581394: Accuracy of BabySat V3 With Profound Hypoxia and Motion
Official title: Accuracy of BabySat V3 With Profound Hypoxia and Motion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoxia
Lead sponsor: Owlet Baby Care, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Francisco
First posted: 2022-10-14
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of accuracy during motion
timeFrame: During the oxygen desaturation assessment
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University California San Fransisco, Department of Anesthesia
state: California
Study officials:
affiliation: University of California, San Francisco
name: John Feiner, MD
role: PRINCIPAL_INVESTIGATOR
References: