Trials / Completed
CompletedNCT03628898
Oxygen Reserve Index (ORi) Validation of INVSENSOR00025
- Status
- Completed
- Phase
- —
- Study type
- Interventional
- Enrollment
- 47 (actual)
- Sponsor
- Masimo Corporation · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
ORi is a unitless index that could help clinicians with their assessments or normoxic and hyperoxic states by scaling the measured absorption information between 0.00 and 1.00. An ORi of 0.00 corresponds to PaO2 values of 100mmHg and below and an ORi of 1.00 corresponds to PaO2 values of 200mmHg and above. In this study, the PaO2 is varied by controlling the concentration of oxygen the study volunteer breathes. Changes in ORi values are analyzed by comparing it to corresponding changes in PaO2 measurements from blood samples.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | INVSENSOR00025 | Noninvasive pulse oximeter sensor |
Timeline
- Start date
- 2018-07-26
- Primary completion
- 2018-08-09
- Completion
- 2018-08-09
- First posted
- 2018-08-14
- Last updated
- 2021-08-27
- Results posted
- 2021-08-27
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03628898. Inclusion in this directory is not an endorsement.