NCT05581394CompletedNot Applicable
Accuracy of BabySat V3 With Profound Hypoxia and Motion
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Owlet Baby Care, Inc.
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Evaluation of accuracy during motion
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 49 Years (Adult)
- Sex
- 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.
Outcomes
Primary Outcomes
Evaluation of accuracy during motion
Time Frame: During the oxygen desaturation assessment
Determine the accuracy during varying degrees of motion and oxygen saturation
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Accuracy of ScanWatch Pulse Oximeter With Profound HypoxiaOximetryNCT04380389Withings14
Recruiting
Not Applicable
Accuracy of Pulse Oximeters During Profound HypoxiaHypoxiaNCT05790616Philips Clinical & Medical Affairs Global66
Completed
Not Applicable
Accuracy of Owlet Smart Sock Sensor 3rd Generation With Profound HypoxiaHypoxiaNCT04446247Owlet Baby Care, Inc.14
Completed
Not Applicable
Pulse Oximeter Accuracy During Stable Hypoxia PlateausHealthyNCT06460246Acurable Ltd.12
Completed
Not Applicable
Controlled Desaturation Study for TipTraQ SpO2 Performance ValidationHypoxiaNCT06634693PranaQ Pte. Ltd.12