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NCT04079816 · ClinicalTrials.gov registry record
Oxygen Reserve Index (ORi) Expanded Data Set Validation of INVSENSOR00025
A clinical trial of Healthy, sponsored by Masimo Corporation.
- Completed
- Registry status
- 29
- Enrollment target
- 1
- Study location
NCT04079816: Completed study of Healthy, sponsored by Masimo Corporation.
NCT04079816 is a study of Healthy that has completed, run by Masimo Corporation. The registered enrollment target is 29 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04079816, a study of Healthy, has completed, sponsored by Masimo Corporation.
- COMPLETED
- Registry status
- 29 participants
- Enrollment target
- 1
- Study location
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 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.
Conditions Studied
Interventions
- DEVICE INVSENSOR00025
Study Locations (1)
California
- Masimo Corporation - Irvine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2019-08-19 |
| Est. Completion | 2019-08-28 |
What the finished NCT04079816 record still lists
NCT04079816 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which INVSENSOR00025 is the first listed.
NCT04079816 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04079816 about?
NCT04079816 is a clinical study titled "Oxygen Reserve Index (ORi) Expanded Data Set Validation of INVSENSOR00025". 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 NCT04079816?
This trial is currently completed. The enrollment target is 29 participants. The study started on 2019-08-19. Estimated completion is 2019-08-28.
What conditions does trial NCT04079816 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT04079816?
The interventions under investigation include: INVSENSOR00025 (DEVICE).
Who is sponsoring clinical trial NCT04079816?
This trial is sponsored by Masimo Corporation, which has 96 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04079816 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04079816's enrollment target sits among peer trials
29 729th of 1090 higher than 356 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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