HypoxiaNCT05297500
Determination of SpO2 and PR Accuracy Specifications at Rest (71Ag_Vital-0031)
An observational study of Hypoxia, run by Nihon Kohden at 1 site in United States.
Trial summary
The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. Study will be used with patients at rest Read more about this study
- Who is it for?
- Ages 18 to 50 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
- 23 Mar 2022to 29 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy adult volunteers. At least 10 subjects will be recruited to complete the study. Of these 2 will be dark pigmented. If the number of samples is less than the required 200 or if less than 2 of dark pigment subjects successfully complete the study, subjects will be added to include 2 of dark pigmented subjects and at least 200 data points.
Who may be able to join
- Both male and female subjects who can give written informed consent
- Healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile
- Meeting the demographic requirements
Who cannot join
- Pregnant women
- Significant arrhythmia
- Blood pressure above 150 systolic or 90 diastolic
- Carboxyhemoglobin levels over 3%
- Subjects whom the investigator consider ineligible for the study
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Hypoxia Research Laboratory
San Francisco, California, 94133
About this study
Official title: Accuracy of Pulse Oximeters With Profound Hypoxia NIHO 14
The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. Study will be used with patients at rest
Read the detailed description
This study is intended to evaluate performance of a new design pulse oximeter (test device) manufactured by Nihon Kohden Corporation sufficiently to support performance claims for an FDA 510K submission or ISO technical file. Specifically, SpO2 and pulse rate accuracy will be assessed for a Nihon Kohden OLV-4202 pulse oximeter with adult patients under a controlled setting of varying levels of inhaled oxygen concentration levels for patients at rest.
- 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
OLV-4202 pulse oximeter (SW version: 01-12)
| Study group | Role | What they receive |
|---|---|---|
| Adult healthy subjects | Adult healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile in an at rest state Receives: Device: Pulse oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Root-mean-square (Rms) of device SpO2 measurement with room air stabilization is within +-2% [%SpO2] of reference co-oximeter SaO2 measurement at varying desaturation levels (70% to 100%)
Each subject will have an arterial catheter inserted in the left or right wrist and the pulse oximeter study device placed on different fingers of the left or right hand, or the left or right earlobe or the forehead. Measurement position is randomized across subjects. For each subject, a series of desaturation runs are performed.
Run 1 stabilized room air period -> stabilized plateaus at saturation level targets:
room air, 92%, 87%, 82%, 77%, 72%
Run 2 stabilized 100% O2 period -> stabilized plateaus at saturation level targets:
100%, 93%, 88%, 83%, 78%, 73%
SpO2 is observed breath by breath arterial saturation, which is in turn computed from end tidal PO2 and PCO2. FiO2 is reduced suddenly at first then adjusted to achieve a stable plateau value at the desired target. Each desaturation plateaus should not exceed 10 minutes. A blood draw is taken at stable FiO2 and +30 seconds. The gas mixture is then changed for the next value and repeated for each plateau value.
Measured: 30 minutes
Root-mean-square (Rms) of device Pulse Rate measurement with room air stabilization is within +-3 [1/min] of reference ECG Pulse Rate measurement at heart rates (30 to 300 [1/min])
Each subject will have an arterial catheter inserted in the left or right wrist and the pulse oximeter study device placed on different fingers of the left or right hand, or the left or right earlobe or the forehead. Measurement position is randomized across subjects. For each subject, a series of desaturation runs are performed.
Run 1 stabilized room air period -> stabilized plateaus at saturation level targets:
room air, 92%, 87%, 82%, 77%, 72%
Run 2 stabilized 100% O2 period -> stabilized plateaus at saturation level targets:
100%, 93%, 88%, 83%, 78%, 73%
Pulse rate is recorded from the test device and from the reference ECG monitor. PR data measurements are gathered during the stable plateau value at the desired saturation target. Each desaturation plateaus should not exceed 10 minutes. The gas mixture is then changed for the next value and repeated for each plateau value.
Measured: 30 minutes
Secondary outcomes (1)
Root-mean-square (Rms) of device SpO2 measurement with room air stabilization is within +-2% [%SpO2] of reference co-oximeter SaO2 measurement at desaturation levels (80% to 100%) and within +-3% [%SpO2] at desaturation levels (70% to 80%)
Each subject will have an arterial catheter inserted in the left or right wrist and the pulse oximeter study device placed on different fingers of the left or right hand, or the left or right earlobe or the forehead. Measurement position is randomized across subjects. For each subject, a series of desaturation runs are performed.
Run 1 stabilized room air period -> stabilized plateaus at saturation level targets:
room air, 92%, 87%, 82%, 77%, 72%
Run 2 stabilized 100% O2 period -> stabilized plateaus at saturation level targets:
100%, 93%, 88%, 83%, 78%, 73%
SpO2 is observed breath by breath arterial saturation, which is in turn computed from end tidal PO2 and PCO2. FiO2 is reduced suddenly at first then adjusted to achieve a stable plateau value at the desired target. Each desaturation plateaus should not exceed 10 minutes. A blood draw is taken at stable FiO2 and +30 seconds. The gas mixture is then changed for the next value and repeated for each plateau value.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start23 Mar 2022
- Primary completion28 Mar 2022
- Study completion29 Oct 2026 (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 (actual)
Sponsor and investigators
- Lead sponsor
- Nihon Kohden
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297500
- Sponsor's protocol ID
- 71Ag_Vital-0031
- Status last verified
- Nov 2024
- First submitted
- 17 Mar 2022
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data to be used by Sponsor only
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Pulse Oximeters With Profound Hypoxia NIHO 14
- ClinicalTrials.gov ID
- NCT05297500
- Acronym / sponsor ID
- 71Ag_Vital-0031
- Conditions
- Hypoxia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Nihon KohdenIndustry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 29 Oct 2026 (estimated)
- First posted
- 28 Mar 2022 (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 aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. Study will be used with patients at rest
Detailed description
This study is intended to evaluate performance of a new design pulse oximeter (test device) manufactured by Nihon Kohden Corporation sufficiently to support performance claims for an FDA 510K submission or ISO technical file. Specifically, SpO2 and pulse rate accuracy will be assessed for a Nihon Kohden OLV-4202 pulse oximeter with adult patients under a controlled setting of varying levels of inhaled oxygen concentration levels for patients at rest.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult healthy subjects | – | Device: Pulse oximeterAdult healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile in an at rest state |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adult volunteers. At least 10 subjects will be recruited to complete the study. Of these 2 will be dark pigmented. If the number of samples is less than the required 200 or if less than 2 of dark pigment subjects successfully complete the study, subjects will be added to include 2 of dark pigmented subjects and at least 200 data points.
Key inclusion criteria (3 listed)
- Both male and female subjects who can give written informed consent
- Healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile
- Meeting the demographic requirements
Key exclusion criteria (5 listed)
- Pregnant women
- Significant arrhythmia
- Blood pressure above 150 systolic or 90 diastolic
- Carboxyhemoglobin levels over 3%
- Subjects whom the investigator consider ineligible for the study
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 oximeterOLV-4202 pulse oximeter (SW version: 01-12) | Device | Adult healthy subjects |
Primary outcome
Root-mean-square (Rms) of device SpO2 measurement with room air stabilization is within +-2% [%SpO2] of reference co-oximeter SaO2 measurement at varying desaturation levels (70% to 100%)
Time frame: 30 minutes
Each subject will have an arterial catheter inserted in the left or right wrist and the pulse oximeter study device placed on different fingers of the left or right hand, or the left or right earlobe or the forehead. Measurement position is randomized across subjects. For each subject, a series of desaturation runs are performed. Run 1 stabilized room air period -> stabilized plateaus at saturation level targets: room air, 92%, 87%, 82%, 77%, 72% Run 2 stabilized 100% O2 period -> stabilized plateaus at saturation level targets: 100%, 93%, 88%, 83%, 78%, 73% SpO2 is observed breath by breath arterial saturation, which is in turn computed from end tidal PO2 and PCO2. FiO2 is reduced suddenly at first then adjusted to achieve a stable plateau value at the desired target. Each desaturation plateaus should not exceed 10 minutes. A blood draw is taken at stable FiO2 and +30 seconds. The gas mixture is then changed for the next value and repeated for each plateau value.
Root-mean-square (Rms) of device Pulse Rate measurement with room air stabilization is within +-3 [1/min] of reference ECG Pulse Rate measurement at heart rates (30 to 300 [1/min])
Time frame: 30 minutes
Each subject will have an arterial catheter inserted in the left or right wrist and the pulse oximeter study device placed on different fingers of the left or right hand, or the left or right earlobe or the forehead. Measurement position is randomized across subjects. For each subject, a series of desaturation runs are performed. Run 1 stabilized room air period -> stabilized plateaus at saturation level targets: room air, 92%, 87%, 82%, 77%, 72% Run 2 stabilized 100% O2 period -> stabilized plateaus at saturation level targets: 100%, 93%, 88%, 83%, 78%, 73% Pulse rate is recorded from the test device and from the reference ECG monitor. PR data measurements are gathered during the stable plateau value at the desired saturation target. Each desaturation plateaus should not exceed 10 minutes. The gas mixture is then changed for the next value and repeated for each plateau value.
1 secondary outcome
Root-mean-square (Rms) of device SpO2 measurement with room air stabilization is within +-2% [%SpO2] of reference co-oximeter SaO2 measurement at desaturation levels (80% to 100%) and within +-3% [%SpO2] at desaturation levels (70% to 80%)
Time frame: 30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No. Data to be used by Sponsor only
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Nihon Kohden 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 3 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 24 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Root-mean-square (Rms) of device SpO2 measurement with room air stabilization is within +-2% [%SpO2] of reference co-oximeter SaO2 measurement at varying desaturation levels (70% to 100%) (time frame: 30 minutes). The study lists 2 primary outcomes in all. 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 24 Nov 2025.