HypoxiaNIHO12NCT04814342

Accuracy of Pulse Oximeters With Profound Hypoxia During Motion

An observational study of Hypoxia, run by Nihon Kohden at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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 during controlled motion. 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: 5 participants
Where: 1 siteUnited States
Study dates: 24 Mar 2021to 15 Feb 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 5 subjects will be recruited to complete the study. Of these, 2 will be dark pigmented.

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

Age below 18 or over 50
Pregnant women
Significant arrhythmia
Blood pressure above 150 systolic or 90 diastolic
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

Other trials in United States

About this study

Official title: Determination of SpO2 and PR Accuracy Specifications During Motion Accuracy of Pulse Oximeters With Profound Hypoxia Pulse Oximeter Accuracy Evaluation Protocol

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 during controlled motion.

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: 01-11)

What is being measured

The primary outcome is the main question the study is designed to answer.

Accuracy of Sensor Oxygen Saturation by Arms Calculation
Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter (SpO2i) to that obtained from a blood sample (SRi) and calculating the arithmetic root mean square (Arms) error value as follows:
Arms =Square root (sum of n samples of ((SpO2i - SRi) squared) / n)
Measured: 30 seconds

Secondary outcomes (1)

Accuracy of Sensor Pulse Rate by Arms Calculation
Accuracy will be determined by comparing the noninvasive pulse rate measurement of the pulse oximeter (PRi) to the heart rate obtained from an electrocardiography reference device (HRRi) and calculating the arithmetic root mean square (Arms) error value as follows:
Arms =Square root (sum of n samples of ((PRi - HRRi) squared) / n)
Measured: 30 seconds

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Mar 202115 Feb 2022

First posted24 Mar 2021
Study start24 Mar 2021
Primary completion24 May 2021
Study completion15 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04814342
Sponsor's protocol ID: 70Ag_Vital-00008
Acronym: NIHO12
Status last verified: Sep 2025
First submitted: 22 Mar 2021
Last updated: 12 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: Data to be used by Sponsor only

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypoxia trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Determination of SpO2 and PR Accuracy Specifications During Motion Accuracy of Pulse Oximeters With Profound Hypoxia Pulse Oximeter Accuracy Evaluation Protocol
ClinicalTrials.gov ID: NCT04814342
Acronym / sponsor ID: NIHO12 / 70Ag_Vital-00008
Conditions: Hypoxia
Study type: Observational
Recruitment status: Completed
Enrolment: 5 participants (actual)
Lead sponsor: Nihon KohdenIndustry (pharma, biotech, devices)
Collaborators: University of California, San Francisco
Study start: 24 Mar 2021 (actual)
Primary completion: 24 May 2021 (actual)
Study completion: 15 Feb 2022 (actual)
First posted: 24 Mar 2021 (actual)
Results: Posted 21 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult
Study population: Healthy adult volunteers. At least 5 subjects will be recruited to complete the study. Of these, 2 will be dark pigmented.

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)

Age below 18 or over 50
Pregnant women
Significant arrhythmia
Blood pressure above 150 systolic or 90 diastolic
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: 01-11)	Device	–

Primary outcome

Accuracy of Sensor Oxygen Saturation by Arms Calculation
Time frame: 30 seconds
Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter (SpO2i) to that obtained from a blood sample (SRi) and calculating the arithmetic root mean square (Arms) error value as follows: Arms =Square root (sum of n samples of ((SpO2i - SRi) squared) / n)

1 secondary outcome

Accuracy of Sensor Pulse Rate by Arms Calculation
Time frame: 30 seconds

Results and safety

Results posted to the registry on 21 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adult Healthy Subjects	5	5

Primary outcome: Accuracy of Sensor Oxygen Saturation by Arms Calculation

Time frame: 30 seconds. Number. Unit: percentage of RMS error

Measure	Adult Healthy Subjects n = 5
Value	1.0

Population analysed: Qualified subjects.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adult Healthy Subjects	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Data to be used by Sponsor only

Related trials for Hypoxia

Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Enrolling by invitation
Extubation Safety Via Microstream EtCO₂ (IPI) Monitoring
Hypoxemia
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
Active, not recruitingPhase 3
A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)
Carcinoma, Renal Cell
RecruitingObservational study
Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
Respiratory Failure, Hypoxemia

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

UCSF Hypoxia Research Laboratory

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: finished, as of the sponsor's last update on 12 Sep 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?

Yes. Results are posted in the registry (first posted 21 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Accuracy of Sensor Oxygen Saturation by Arms Calculation (time frame: 30 seconds). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04814342.

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 12 Sep 2025.