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NCT04079842 · ClinicalTrials.gov registry record
Oxygen Reserve Index (ORi) Expanded Data Set Validation of INVSENSOR00029
A clinical trial, sponsored by Masimo Corporation.
- Completed
- Registry status
- 29
- Enrollment target
NCT04079842: Completed study, sponsored by Masimo Corporation.
NCT04079842 is a clinical trial that has completed, run by Masimo Corporation. The registered enrollment target is 29 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04079842 has completed, sponsored by Masimo Corporation.
- COMPLETED
- Registry status
- 29 participants
- Enrollment target
Study Summary
ORi is a unitless index 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. Changes in ORi values are analyzed by comparing it to corresponding changes in PaO2 measurements from blood samples.
Primary Outcome
ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore, sensitivity, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2.
Interventions
- DEVICE INVSENSOR00029
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2019-08-20 |
| Est. Completion | 2019-08-28 |
What the finished NCT04079842 record still lists
NCT04079842 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which INVSENSOR00029 is the first listed.
NCT04079842 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04079842 about?
NCT04079842 is a clinical study titled "Oxygen Reserve Index (ORi) Expanded Data Set Validation of INVSENSOR00029". ORi is a unitless index 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 an...
What is the current status of trial NCT04079842?
This trial is currently completed. The enrollment target is 29 participants. The study started on 2019-08-20. Estimated completion is 2019-08-28.
What interventions are being tested in trial NCT04079842?
The interventions under investigation include: INVSENSOR00029 (DEVICE).
Who is sponsoring clinical trial NCT04079842?
This trial is sponsored by Masimo Corporation, which has 96 total clinical trials registered on ClinicalTrials.gov.
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