Loading clinical trials...

Pulse Oximeter Accuracy During Stable Hypoxia Plateaus | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITING

Pulse Oximeter Accuracy During Stable Hypoxia Plateaus

NCT07408388•Nihon Kohden

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.

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Yes

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

•1. The subject has a BMI above 40
•2. The subject has blood pressure above 160 systolic or 95 diastolic
•3. The subject has a known history of heart disease, lung disease, kidney or liver disease.
•4. Diagnosis of asthma, sleep apnea, or use of CPAP.
•5. Subject has diabetes.
•6. Subject has a clotting disorder.
•7. 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).
•8. The subject has any other serious systemic illness.
•9. The subject has smoked in the last 12 hours.
•10. Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators would interfere with the sensors working correctly.
+8 more criteria

Locations (1)

Vital Sign Research Group

San Francisco, California, United States

Key Dates

Start Date

December 3, 2025

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2027

Last Updated

February 17, 2026

Enrollment

ESTIMATED participants

Conditions

Hypoxia

Interventions

Pulse Oximeter

DEVICE

Induced hypoxia through breathing nitrogen-air-carbon dioxide mixture

PROCEDURE

The Effectiveness of Oxygen Reserve Index in Early Detection of Desaturation in Geriatric Patients Scheduled for Oncological Surgery

NCT07326293

DesaturationApnea, Hypoxia+1 more

View study

RECRUITINGNA

Nasopharyngeal Airway Combined With Nasal High-flow Oxygen Therapy During Painless Gastroscopy in Obesity Patients

NCT06966934

HypoxiaObesity+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Pulse Oximeter Accuracy During Stable Hypoxia Plateaus

Inclusion Criteria

Exclusion Criteria

The Effectiveness of Oxygen Reserve Index in Early Detection of Desaturation in Geriatric Patients Scheduled for Oncological Surgery

Nasopharyngeal Airway Combined With Nasal High-flow Oxygen Therapy During Painless Gastroscopy in Obesity Patients

Added Diagnostic Value of Point of Care Ultrasound in Acute Dyspnea

Cord Blood S100B Protein Levels in Neonates Following Intrauterine Transfusions for HDFN-Associated Fetal Anemia

High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill

Effect of Percutaneous Electrical Acupoint Stimulation on the Improvement of Incidence of Adverse Respiratory Events