Healthy
Conditions
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.
Interventions
DEVICEPulse Oximeter
The subjects will have a 22-gauge catheter inserted in the radial artery to measure the oxygen saturation of arterial blood and also wear pulse oximeters.
Sponsors
Acurable Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed