Accuracy of BabySat V3 With Profound Hypoxia and Motion

Completed

• Conditions: Hypoxia

• Registration Number: NCT05581394
• Lead Sponsor: Owlet Baby Care, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-14
• Primary Completion: 2022-07-15
• Study Completion: 2022-07-15
• Status Verified: 2022-10
• Study First Submitted: 2022-10-06
• Study First Submitted QC: 2022-10-12
• Last Update Submitted: 2022-10-12
• Study First Posted: 2022-10-14
• Last Update Posted: 2022-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of accuracy during motion	During the oxygen desaturation assessment	Determine the accuracy during varying degrees of motion and oxygen saturation

Trial Locations

Locations (1)

University California San Fransisco, Department of Anesthesia; 🇺🇸 San Francisco, California, United States