Pulse Oximeter Accuracy in Healthy Humans During Hypoxia

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Nov 15, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how accurate pulse oximeters are in measuring blood oxygen levels during different levels of low oxygen (called hypoxia). The researchers want to see if these devices work well in healthy people when their oxygen levels drop slightly, moderately, or severely. This study is open to healthy men and women aged 21 to 50 who speak and understand English and are willing to follow the study's guidelines.

Participants in this trial will undergo tests where their blood oxygen levels will be measured using both a pulse oximeter and a more precise method. It's important to note that some people may not be eligible to participate, such as those with obesity, heart or lung diseases, diabetes, or certain other health conditions. If you qualify and choose to join, you'll be helping researchers understand how pulse oximeters work in different situations, which could improve care for patients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. The subject is male or female, aged ≥21 and \<50.
• • 2. The subject is in good general health with no evidence of any medical problems.
• • 3. The subject is fluent in both written and spoken English.
• • 4. The subject has provided informed consent and is willing to comply with the study procedures.
• Exclusion Criteria:
• • 1. The subject is obese (BMI\>30).
• • 2. The subject has a known history of heart disease, lung disease, kidney or liver disease.
• • 3. Diagnosis of asthma, sleep apnea, or use of CPAP.
• • 4. Subject has diabetes.
• • 5. Subject has a clotting disorder.
• • 6. The subject 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.
• • 7. The subject has any other serious systemic illness.
• • 8. The subject is a current smoker.
• • 9. Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.
• • 10. The subject has a history of fainting or vasovagal response.
• • 11. The subject has a history of sensitivity to local anesthesia.
• • 12. The subject has a diagnosis of Raynaud's disease.
• • 13. The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
• • 14. The subject is pregnant, lactating or trying to get pregnant.
• • 15. The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
• • 16. The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.