Trials / Completed
CompletedNCT05581394
Accuracy of BabySat V3 With Profound Hypoxia and Motion
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 12 (actual)
- Sponsor
- Owlet Baby Care, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 49 Years
- Healthy volunteers
- Accepted
Summary
Performance testing of pulse oximeters. The protocol involves brief stable arterial oxygen desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia has been attained and during different motion scenarios. The blood sample is analyzed for oxygen saturation with a gold standard bench CO-oximeter. This protocol is aligned with the latest ISO and FDA guidance documents for pulse oximeter testing.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | BabySat V3 | Evaluation of Accuracy of BabySat V3 |
Timeline
- Start date
- 2022-07-14
- Primary completion
- 2022-07-15
- Completion
- 2022-07-15
- First posted
- 2022-10-14
- Last updated
- 2022-10-14
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05581394. Inclusion in this directory is not an endorsement.