Trials / Completed
CompletedNCT04562584
Pulse Oximeter Hypoxia
Accuracy of Pulse Oximeters With Profound Hypoxia
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- MyHomeDoc Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
The aim of this project is to test the accuracy of pulse oximeters (devices intended to measure oxygen saturation in blood noninvasively) during mild, moderate and severe hypoxia (a lower-than-normal concentration of oxygen in arterial blood); ie, a range of arterial HbO2 saturations from 100 to down to 70%. This is done by comparing the reading of the pulse oximeter during brief, steady state hypoxia with a gold-standard measurement of blood oxyhemoglobin (hemoglobin carrying oxygen) saturation, that is arterial blood sample processed in a laboratory.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MyHomeDoc | MyHomeDoc device SpO2 measurements and parallel blood gas analysis to determine oxyhemoglobin saturation (SaO2) using an ABL-90 multi-wavelength oximeter. |
Timeline
- Start date
- 2020-06-03
- Primary completion
- 2020-06-04
- Completion
- 2020-06-04
- First posted
- 2020-09-24
- Last updated
- 2020-09-24
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04562584. Inclusion in this directory is not an endorsement.