Pulse Oximeter Accuracy During Stable Hypoxia Plateaus
Not Applicable
Completed
- Conditions
- Healthy
- Registration Number
- NCT06460246
- Lead Sponsor
- Acurable Ltd.
- Brief Summary
This project aims to test the accuracy of pulse oximeters in the range of arterial HbO2 saturations from 100% down to 70%.
- Detailed Description
This project aims to test the accuracy of pulse oximeters in the range of arterial HbO2 saturations from 100% down to 70%. This is done by comparing the pulse oximeter reading during brief, steady state hypoxia plateaus with a gold-standard measurement of blood oxyhaemoglobin saturation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Performance of the pulse oximeters against corresponding arterial blood oxygen saturation. 1-4 hours Performance of the pulse oximeters against corresponding arterial blood oxygen saturation.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Vital Signs Research Group, L.L.C.
🇺🇸San Francisco, California, United States
Vital Signs Research Group, L.L.C.🇺🇸San Francisco, California, United States