NCT05139693

Accuracy of Pulse Oximeters With Profound Hypoxia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 12 (actual)
• Sponsor: Respiree Pte Ltd · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DEVICE	Respiree	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

Timeline

• Start date: 2021-12-15
• Primary completion: 2021-12-16
• Completion: 2021-12-16
• First posted: 2021-12-01
• Last updated: 2022-04-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study