Accuracy of the EvieMED Ring Pulse Oximeter in Profound Hypoxia

Hypoxia Clinical Trial

Official title:

Accuracy of the Evie Ring Pulse Oximeter in Profound Hypoxia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06459206
• Other study ID #: MOVA06
• Status: Recruiting
• Start date: June 11, 2024
• Est. completion date: June 13, 2024

Study information

• Verified date: June 2024
• Source: Movano Health
• Contact: Kim Tompkins
• Phone: +1 (408) 981-488
• Email: ktompkins[@]movano.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

The study is an open enrollment, single-center, single blinded design using four test rings in motion compared to arterial blood gas measurements (SaO2) and to two commercially available hospital grade reference pulse oximeters (Masimo Radical-7 and Nellcor N-595) and at rest for two test rings and the test wrist device. To be included in the study, subjects had to meet all the inclusion criteria and not meet any of the exclusion criteria and to sign the written consent. Demographic data were obtained.

The investigational (7/subject) and reference devices were placed. A radial arterial cannula was placed in either the left or right wrist of each subject for arterial blood sampling and blood pressure monitoring. Each subject had two control blood samples taken at the beginning of each experiment, while breathing room air. Hands with test devices and reference pulse oximeters were maintained in motion or motionless on arm boards throughout the test. Hypoxemia was then induced to different and stable levels of oxyhemoglobin saturation (between 70-100%) by having subjects breathe mixtures of nitrogen, air, and carbon dioxide. The mixture of gases was controlled by the study physician by adjusting gas flows according to breath-by-breath estimates of oxygen saturation calculated from end-tidal partial pressure of oxygen (PO2) and partial pressure of carbon dioxide (PCO2). Each plateau level of oxyhemoglobin saturation was maintained for at least 30 seconds or until readings were stable. Two arterial blood samples were then obtained, approximately 30 seconds apart. Each stable plateau was maintained for at least 60 seconds with SpO2 fluctuating by less than 2-3%. All investigational, control, and reference data were recorded.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: June 13, 2024
• Est. primary completion date: June 13, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

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 Criteria:

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.

Related Conditions & MeSH terms

• Hypoxia

Intervention

Device:
• Pulse 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.

Locations

Country	Name	City	State
United States	Hypoxia Research Laboratory	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Movano Health	University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test devices oxygen saturation accuracy	Root Mean Squared Error (RMSE) between test devices in motion and motionless saturation of peripheral oxygen and arterial oxygen saturation.	2 days