Trials / Terminated
TerminatedNCT03500341
Oxygen Reserve Index (ORi) Validation of INVSENSOR00014
- Status
- Terminated
- Phase
- —
- Study type
- Interventional
- Enrollment
- 33 (actual)
- Sponsor
- Masimo Corporation · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
The Oxygen Reserve Index (ORi) is a reference that could help clinicians with their assessments of 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. The ORI device measurement is analyzed by comparing it to the PaO2 measurements from blood samples from a laboratory analyzer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | INVSENSOR00014 | Noninvasive pulse oximeter sensor |
Timeline
- Start date
- 2018-03-21
- Primary completion
- 2018-08-01
- Completion
- 2018-08-01
- First posted
- 2018-04-18
- Last updated
- 2021-09-08
- Results posted
- 2021-09-08
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03500341. Inclusion in this directory is not an endorsement.