RecruitingNCT06459206

Accuracy of the EvieMED Ring Pulse Oximeter in Profound Hypoxia

Accuracy of the Evie Ring Pulse Oximeter in Profound Hypoxia

Sponsor

Movano Health

Enrollment

12 participants

Start Date

Jun 11, 2024

Study Type

OBSERVATIONAL

Conditions

Hypoxia

Summary

The goal of this study was to evaluate the accuracy of pulse oximeters over the range of 70-100% per the International Organization for Standardization (ISO) 80601-2-61:2019. Four test devices were placed on each subject on the left or right hand with two at the finger base and two at the fingertip. Motion equipment was used to control motion of the test devices. In addition, two test devices were placed on the contralateral hand on the base of a finger and also on the fingertip. Finally, a test wrist device was placed on either the left or right wrist. SpO2 measurements from these devices were compared to sampling of arterial blood during brief stable oxygen desaturation in healthy volunteers to evaluate the claimed range.

Eligibility

Min Age: 18 YearsMax Age: 49 Years

Inclusion Criteria2

Subject is in good general health with no evidence of any medical problems. Subject is fluent in both written and spoken English. Subject provided written informed consent and is willing to comply with the study procedures.
Subject is willing to have their skin color assessed.

Exclusion Criteria6

Subject is obese with a body mass index (BMI) over 30. Subject has a known history of heart disease, lung disease, kidney or liver disease.
Subject has asthma, sleep apnea, or uses continuous positive airway pressure breathing support Subject has diabetes. Subject has a clotting disorder, anemia, or in the opinion of the investigator, they would be unsuitable for participation.
Subject has any other serious system illness. Subject is a current smoker. Subject has any injury, deformity, or abnormality at the sensor sites that, in the opinion of the investigator, would interfere with the sensors working correctly.
Subject has a history of fainting or vasovagal response. Subject has a sensitivity to local anesthesia. Subject has Raynaud's disease. Subject has unacceptable collateral circulation based on an exam by the investigator.
Subject is pregnant, lactating, or trying to get pregnant. Subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with the study procedures.
Subject has any other condition, which in the opinion of the investigator, would make them unsuitable for the study.

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Interventions

DEVICEPulse oximeter

Devices (4) were placed on the finger base and the fingertip of two right or left fingers and placed in motion for the duration of the study. Devices (3) were placed on the contralateral side and maintained motionless for the duration of the of study. Blood samples were taken at each stable level of oxygenation.