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NCT03678103 · ClinicalTrials.gov registry record
Oxygen Reserve Index (ORi) Validation of INVSENSOR00029
A clinical trial, sponsored by Masimo Corporation.
- Completed
- Registry status
- 57
- Enrollment target
NCT03678103: Completed study, sponsored by Masimo Corporation.
NCT03678103 is a clinical trial that has completed, run by Masimo Corporation. The registered enrollment target is 57 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03678103 has completed, sponsored by Masimo Corporation.
- COMPLETED
- Registry status
- 57 participants
- Enrollment target
Study 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.
Primary Outcome
ORi is an index value without a unit. Sensitivity, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2 at 150 mmHg.
Interventions
- DEVICE INVSENSOR00029
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2018-08-29 |
| Est. Completion | 2018-09-13 |
What the finished NCT03678103 record still lists
NCT03678103 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which INVSENSOR00029 is the first listed.
NCT03678103 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03678103 about?
NCT03678103 is a clinical study titled "Oxygen Reserve Index (ORi) Validation of INVSENSOR00029". 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...
What is the current status of trial NCT03678103?
This trial is currently completed. The enrollment target is 57 participants. The study started on 2018-08-29. Estimated completion is 2018-09-13.
What interventions are being tested in trial NCT03678103?
The interventions under investigation include: INVSENSOR00029 (DEVICE).
Who is sponsoring clinical trial NCT03678103?
This trial is sponsored by Masimo Corporation, which has 96 total clinical trials registered on ClinicalTrials.gov.
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