Pulse Oximeter Accuracy During Stable Hypoxia Plateaus
- Conditions
- Healthy
- Registration Number
- NCT06460246
- Lead Sponsor
- Acurable Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Male or female, aged >= 18 and < 50.<br><br> - Subject in good general health with no evidence of any medical problems.<br><br> - Subject is fluent in both written and spoken English.<br><br> - Subject has provided informed consent and is willing to comply with the study<br> procedures.<br><br>Exclusion Criteria:<br><br> - Subject is obese (BMI > 35).<br><br> - Subject has a known history of heart disease, lung disease, kidney, or liver<br> disease.<br><br> - Diagnosis of asthma, sleep apnea, or use of CPAP.<br><br> - Subject has diabetes.<br><br> - Subject has a clotting disorder.<br><br> - Subject has hemoglobinopathy or history of anemia, per subject report or the first<br> blood sample, that in the opinion of the investigator, would make them unsuitable<br> for study participation.<br><br> - Subject has any other serious systemic illness.<br><br> - Subject is a current smoker.<br><br> - Any injury, deformity, or abnormality at the sensor sites that in the opinion of the<br> investigators would interfere with the sensors working correctly.<br><br> - Subject has a history of fainting or vasovagal response.<br><br> - Subject has a history of sensitivity to local anesthesia.<br><br> - Subject has a diagnosis of Raynaud's disease.<br><br> - Subject has unacceptable collateral circulation based on exam by the investigator<br> (Allen's test).<br><br> - Subject is pregnant, lactating, or trying to get pregnant.<br><br> - Subject is unable or unwilling to provide informed consent, or is unable or<br> unwilling to comply with study procedures.<br><br> - Subject has any other condition, which in the opinion of the investigators would<br> make them unsuitable for the study.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Performance of the pulse oximeters against corresponding arterial blood oxygen saturation.
- Secondary Outcome Measures
Name Time Method