Pulse Oximeter Accuracy During Stable Hypoxia Plateaus

NCT07408388 | Active Not Recruiting

• 1 other identifier: 75Ag-00030
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxia

Keywords

Hypoxia; Pulse oximetry; SpO2; Pulse oximeter

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Pulse Oximeter DEVICE

OLV-4202 pulse oximeter ((SW version: 01-17)

Adult healthy subjects

Induced hypoxia through breathing nitrogen-air-carbon dioxide mixture PROCEDURE

Subjects will be placed in a seated semi-reclined position. Subjects will breathe a nitrogen-air-carbon dioxide mixture to produce the desired level of hypoxemia. Stable, safe and controlled hypoxia is obtained by breath-by-breath analysis of respiratory gas using a gas analyzer that permits the inspired gas mixture to be adjusted to achieve the desired degree of blood oxygen saturation. Study is observational to see response of pulse oximeter. Intervention (above) is not therapeutic, rather is simply used to vary oxygen levels in subjects.

Adult healthy subjects

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nihon Kohden: lead

Study Sites (1)

Vital Sign Research Group

San Francisco, California, 94107, United States

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Greg Stratmann, MD, PhD

  University of California, San Francisco, Department of Anesthesia and Perioperative Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: February 13, 2026
• Study Start: December 3, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)