Respiree Pte Ltd
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 oxyhemoglobin saturation (arterial blood sample processed in a laboratory hemoximeter). The data obtained is submitted by pulse oximeter manufacturers to the FDA for device approval.
Healthy Volunteers
Respiree
The study will include at least 10 subjects (up to 14 if needed to reach the 200 necessary data points to meet the ISO 80601-2-61:2017). Per FDA guidance, at least 2, or 15% of the subjects will have dark skin.}}
Study Type : | Observational |
Estimated Enrollment : | 12 participants |
Official Title : | Accuracy of Pulse Oximeters With Profound Hypoxia |
Actual Study Start Date : | December 15, 2021 |
Estimated Primary Completion Date : | December 16, 2021 |
Estimated Study Completion Date : | December 16, 2021 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years to 49 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Hypoxia Research Laboratory
San Francisco, California, United States, 94143