Pulse Oximeter Accuracy During Stable Hypoxia Plateaus

Completed · Not applicable

Conditions studied: Healthy

In brief

This project aims to test the accuracy of pulse oximeters in the range of arterial HbO2 saturations from 100% down to 70%.

Key facts

Study ID

NCT06460246

Run by

Acurable Ltd.

People needed

12

Starts

2024-06-25

Expected to finish

2024-07-31

Last updated by the study team

2024-08-23

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female, aged >= 18 and < 50.
• Subject in good general health with no evidence of any medical problems.
• Subject is fluent in both written and spoken English.
• Subject has provided informed consent and is willing to comply with the study procedures.

You may not qualify if…

• Subject is obese (BMI > 35).
• 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.
• Subject has 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.
• Subject has any other serious systemic illness.
• Subject is a current smoker.
• Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators would interfere with the sensors working correctly.
• Subject has a history of fainting or vasovagal response.
• Subject has a history of sensitivity to local anesthesia.
• Subject has a diagnosis of Raynaud's disease.
• Subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
• Subject is pregnant, lactating, or trying to get pregnant.
• Subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
• Subject has any other condition, which in the opinion of the investigators would make them unsuitable for the study.

Where it is running

• Vital Signs Research Group, L.L.C. — San Francisco, California, United States

Full record on ClinicalTrials.gov

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