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NCT03500341 · ClinicalTrials.gov registry record
Oxygen Reserve Index (ORi) Validation of INVSENSOR00014
A clinical trial, sponsored by Masimo Corporation.
- Terminated
- Registry status
- 33
- Enrollment target
NCT03500341: Clinical Trial study, sponsored by Masimo Corporation.
NCT03500341 is a clinical trial that was terminated before completion, run by Masimo Corporation. The registered enrollment target is 33 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03500341 was terminated before completion, sponsored by Masimo Corporation.
- TERMINATED
- Registry status
- 33 participants
- Enrollment target
Study 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.
Primary Outcome
This study reports ORi specificity, sensitivity and concordance for Masimo's ORi measurement system as compared to PaO2 from blood samples.
Interventions
- DEVICE INVSENSOR00014
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2018-03-21 |
| Est. Completion | 2018-08-01 |
Why NCT03500341 stopped before completion
NCT03500341 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which INVSENSOR00014 is the first listed.
NCT03500341 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03500341 about?
NCT03500341 is a clinical study titled "Oxygen Reserve Index (ORi) Validation of INVSENSOR00014". 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...
What is the current status of trial NCT03500341?
This trial is currently terminated. The enrollment target is 33 participants. The study started on 2018-03-21. Estimated completion is 2018-08-01.
What interventions are being tested in trial NCT03500341?
The interventions under investigation include: INVSENSOR00014 (DEVICE).
Who is sponsoring clinical trial NCT03500341?
This trial is sponsored by Masimo Corporation, which has 96 total clinical trials registered on ClinicalTrials.gov.
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