Pulse Oximeter Accuracy During Stable Hypoxia Plateaus | NCT07408388

Studies
Pulse Oximeter Accuracy During Stable Hypoxia Plateaus

NCT07408388

Sponsor

Nihon Kohden

Status

Active, not recruiting

Last Update Posted

Feb 17, 2026Actual

Enrollment

48Estimated

Phase

Not provided

Conditions

Hypoxia

Interventions

Pulse Oximeter
Induced hypoxia through breathing nitrogen-air-carbon dioxide mixture

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 3, 2025Actual

Primary Completion Date

Dec 1, 2026Estimated

Completion Date

Dec 1, 2027Estimated

First Submitted Date

Nov 28, 2025

First Submission Date that Met QC Criteria

Feb 10, 2026

First Posted Date

Feb 13, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2026

Last Update Posted Date

Feb 17, 2026Actual

Description Module

Brief 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 healthy volunteers at rest.

Detailed Description

This study will evaluate the accuracy of Nihon Kohden pulse oximeters and sensors in measuring arterial oxygen saturation (SpO₂) in healthy adult volunteers. Subjects will undergo controlled reductions in blood oxygen levels (down to 70%) while SpO₂ readings from the test devices are compared to reference values from arterial blood samples. The study is designed to meet current ISO and FDA requirements, and results may be used to support regulatory submissions. Data will be analyzed for overall accuracy and potential differences by skin tone and sex.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Week

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

48Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adult healthy subjects		Adult healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile in an at rest state	Device: Pulse Oximeter Procedure: Induced hypoxia through breathing nitrogen-air-carbon dioxide mixture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pulse Oximeter	Device	OLV-4202 pulse oximeter ((SW version: 01-17)	Adult healthy subjects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Accuracy of Sensor Oxygen Saturation by Arms Calculation	Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter (SpO2) to that obtained from a blood sample (SaO2) and calculating the arithmetic root mean square (Arms) error value as follows: Arms = Square root (sum of n samples of ((SpO2i - SRi) squared) / n)	Up to 15 min

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The subject is male or female, aged 18 to 50.
The subject is in good general health with no evidence of any medical problems
The subject is fluent in both written and spoken English.
The subject has provided informed consent and is willing to comply with the study procedures.

Exclusion Criteria:

The subject has a BMI above 40
The subject has blood pressure above 160 systolic or 95 diastolic
The subject has a known history of heart disease, lung disease, kidney or liver disease.
Diagnosis of asthma, sleep apnea, or use of CPAP.
Subject has diabetes.
Subject has a clotting disorder.
The subject has a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation. (COHb<3%, MetHb<2%, ctHb>10 g/dL).
The subject has any other serious systemic illness.
The subject has smoked in the last 12 hours.
Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators would interfere with the sensors working correctly.
The subject has a history of fainting or vasovagal response.
The subject has a history of sensitivity to local anesthesia.
The subject has a diagnosis of Raynaud's disease.
The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
The subject is pregnant, lactating or trying to get pregnant.
Subjects who have uneven skin tones at the forehead or the sensor site.
The subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with study procedures.
The subject has any other condition, which in the opinion of the investigators would make them unsuitable for the study.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Healthy adult volunteers. At least 48 new subjects will be enrolled. Subjects will be selected with reference to ISO and FDA requirements to ensure appropriate representation across skin tone categories (Monk Skin Tone scale) and sex.

Sampling Method

Non-Probability Sample

ID	Term
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms