Trials / Completed
CompletedNCT03435224
Desaturation Validation of INVSENSOR00012
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- Masimo Corporation · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
This study is designed to compare the accuracy of a noninvasive measurement of oxygen saturation compared to reference values obtained by a laboratory blood gas analyzer. Arterial blood samples will be collected from healthy adult subjects while undergoing a desaturation procedure wherein the concentration of oxygen inhaled is slowly reduced until the subject's arterial oxygen concentration is approximately 70%. During the desaturation, the subject's hand and arm without the arterial line will be subjected to motion.After completing the desaturation, the gas mixture will be returned to room air concentrations.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | INVSENSOR00012 | Noninvasive pulse oximeter sensor |
Timeline
- Start date
- 2018-01-17
- Primary completion
- 2018-02-12
- Completion
- 2018-02-12
- First posted
- 2018-02-15
- Last updated
- 2024-10-01
- Results posted
- 2021-03-30
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03435224. Inclusion in this directory is not an endorsement.