Hypoxia
Conditions
Keywords
Hypoxia, Pulse oximetry, SpO2, Pulse oximeter
Brief 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.
Interventions
DEVICEPulse Oximeter
OLV-4202 pulse oximeter ((SW version: 01-17)
PROCEDUREInduced hypoxia through breathing nitrogen-air-carbon dioxide mixture
Subjects will be placed in a seated semi-reclined position. Subjects will breathe a nitrogen-air-carbon dioxide mixture to produce the desired level of hypoxemia. Stable, safe and controlled hypoxia is obtained by breath-by-breath analysis of respiratory gas using a gas analyzer that permits the inspired gas mixture to be adjusted to achieve the desired degree of blood oxygen saturation. Study is observational to see response of pulse oximeter. Intervention (above) is not therapeutic, rather is simply used to vary oxygen levels in subjects.
Sponsors
Nihon Kohden
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
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. 11. The subject has a history of fainting or vasovagal response. 12. The subject has a history of sensitivity to local anesthesia. 13. The subject has a diagnosis of Raynaud's disease. 14. The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test). 15. The subject is pregnant, lactating or trying to get pregnant. 16. Subjects who have uneven skin tones at the forehead or the sensor site. 17. The subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with study procedures. 18. The 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 |
|---|---|---|
| Accuracy of Sensor Oxygen Saturation by Arms Calculation | Up to 15 min | Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter (SpO2) to that obtained from a blood sample (SaO2) and calculating the arithmetic root mean square (Arms) error value as follows: Arms = Square root (sum of n samples of ((SpO2i - SRi) squared) / n) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGreg Stratmann, MD, PhD
University of California, San Francisco, Department of Anesthesia and Perioperative Care
Outcome results
None listed