Hypoxia Clinical Trial
Official title:
Pulse Oximeter Accuracy in Healthy Humans During Hypoxia
NCT number | NCT06142019 |
Other study ID # | 21-35637 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2024 |
Est. completion date | August 1, 2025 |
The aim of this project is to test the accuracy of pulse oximeters during mild, moderate and severe hypoxia. This is done by comparing the reading of the pulse oximeter during brief, steady state hypoxia with a gold-standard measurement of blood oxygen. This study will be done on healthy male or females between the age group of 18-50.
Status | Recruiting |
Enrollment | 10000 |
Est. completion date | August 1, 2025 |
Est. primary completion date | August 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 50 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Hypoxia Lab, UCSF Department of Anesthesia and Perioperative Care | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
Bickler PE, Feiner JR, Severinghaus JW. Effects of skin pigmentation on pulse oximeter accuracy at low saturation. Anesthesiology. 2005 Apr;102(4):715-9. doi: 10.1097/00000542-200504000-00004. — View Citation
Feiner JR, Bickler PE, Mannheimer PD. Accuracy of methemoglobin detection by pulse CO-oximetry during hypoxia. Anesth Analg. 2010 Jul;111(1):143-8. doi: 10.1213/ANE.0b013e3181c91bb6. Epub 2009 Dec 10. — View Citation
Feiner JR, Severinghaus JW, Bickler PE. Dark skin decreases the accuracy of pulse oximeters at low oxygen saturation: the effects of oximeter probe type and gender. Anesth Analg. 2007 Dec;105(6 Suppl):S18-S23. doi: 10.1213/01.ane.0000285988.35174.d9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SpO2 | Reading on pulse oximeter device which is an estimate of the patient's blood oxygen level. | 08/01/2025 | |
Secondary | Blood gas SO2 | Arterial blood gas sample results showing exact SpO2 levels. SpO2 ranges from 1% to 100%. Our target SpO2 levels are between 67% and 100%. | 08/01/2025 | |
Secondary | Skin Pigmentation by ITA | ITA stands for individual typology angle from a spectrophotometer which is an objective measurement of skin pigmentation. The categories for the ITA scale are the following: > 55 Very Light, 41 to 55 Light, 28 to 41 Intermediate, 10 to 28 Tan, -30 to 10 Brown, < -30 Dark. | 08/01/2025 | |
Secondary | Finger Diameter | Finger diameter is measured to ensure that the pulse oximeters being tested work with a variety of finger sizes. Finger diameter is measured in mm. | 08/01/2025 | |
Secondary | Skin Pigmentation by Monk Scale | The Monk scale is a subjective categorization of skin pigmentation. The Monk Scale is a 10 shade scale designed to to be easy-to-use for development and evaluation of technology while presenting a more representative range of skin tones than other common qualitative scales. The Monk Scale is from A to J. A being the lightest skin color and J the darkest. | 08/01/2025 |
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