HypoxiaNCT06459206
Accuracy of the EvieMED Ring Pulse Oximeter in Profound Hypoxia
An observational study of Hypoxia, run by Movano Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia
- What is being tested?
- Pulse oximeter
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2024to 13 Jun 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy adult participants 18 to 49 years old, of which 2 or 15% of the subject pool is darkly pigmented.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Hypoxia Research Laboratory
San Francisco, California, 94133
Philip Bickler, MD
About this study
Official title: Accuracy of the Evie Ring Pulse Oximeter in Profound Hypoxia
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.
Read the detailed 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.
- Conditions
- Hypoxia
- Being tested
- Pulse oximeter
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse oximeterDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Adult Volunteers | Minimum of ten (10) subjects meeting the eligibility criteria. Receives: Device: Pulse oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start11 Jun 2024 (estimated)
- Primary completion13 Jun 2024 (estimated)
- Study completion13 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Movano Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Philip Bickler, MD, PhD, Principal investigator, University of California at San Francisco (UCSF)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459206
- Sponsor's protocol ID
- MOVA06
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of the Evie Ring Pulse Oximeter in Profound Hypoxia
- ClinicalTrials.gov ID
- NCT06459206
- Acronym / sponsor ID
- MOVA06
- Conditions
- Hypoxia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Movano HealthIndustry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco
- Study start
- 11 Jun 2024 (estimated)
- Primary completion
- 13 Jun 2024 (estimated)
- Study completion
- 13 Jun 2024 (estimated)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Adult Volunteers | – | Device: Pulse oximeterMinimum of ten (10) subjects meeting the eligibility criteria. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adult participants 18 to 49 years old, of which 2 or 15% of the subject pool is darkly pigmented.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulse oximeterDevices (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. | Device | Healthy Adult Volunteers |
Primary outcome
Test devices oxygen saturation accuracy
Time frame: 2 days
Root Mean Squared Error (RMSE) between test devices in motion and motionless saturation of peripheral oxygen and arterial oxygen saturation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Hypoxia
Enrolling by invitation
Extubation Safety Via Microstream EtCO₂ (IPI) Monitoring
Hypoxemia
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingPhase 2/3
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia
Hypoxic-Ischemic Encephalopathy
RecruitingObservational study
Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
Respiratory Failure, Hypoxemia
RecruitingPhase 2
The PROTECT-HIE Pilot Trial
Hypoxic-ischemic Encephalopathy (HIE)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Bickler, MD, PhD principal investigator
University of California at San Francisco (UCSF)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxia, run by Movano Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kim Tompkins (+1 (408) 981-488, ktompkins@movano.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test devices oxygen saturation accuracy (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024; AzTrials last refreshed its copy on 7 Nov 2026.