Trials / Completed
CompletedNCT04964609
EmbracePlus SpO2 Accuracy Validation
Accuracy of Pulse Oximeters With Profound Hypoxia
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- Empatica, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The aim of this study is to test the accuracy of EmbracePlus computed SpO2 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 the subject device 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 | EmbracePlus | A device intended for use by researchers and healthcare professionals for continuous collection of physiological parameters in home and healthcare settings. Parallel blood gas analysis to determine oxyhemoglobin saturation (SaO2) using an ABL-90 multi-wavelength oximeter. |
Timeline
- Start date
- 2021-06-16
- Primary completion
- 2022-11-21
- Completion
- 2022-11-21
- First posted
- 2021-07-16
- Last updated
- 2022-11-25
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04964609. Inclusion in this directory is not an endorsement.