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NCT02841397 · ClinicalTrials.gov registry record
Validation of Noninvasive Hemoglobin, Comparison of PVI to Standard Methods, and Validation of Clinical Efficacy of ORI
A clinical trial, sponsored by Masimo Corporation.
- Completed
- Registry status
- 50
- Enrollment target
NCT02841397: Completed study, sponsored by Masimo Corporation.
NCT02841397 is a clinical trial that has completed, run by Masimo Corporation. The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02841397 has completed, sponsored by Masimo Corporation.
- COMPLETED
- Registry status
- 50 participants
- Enrollment target
Study Summary
The study goal is to establish the correlation of hemoglobin values determined by the noninvasive pulse oximetry-determined hemoglobin (SpHb) system with hemoglobin as measured by other validated devices. The study will also evaluation oxygen reserve index (ORI) to correlate with partial pressure of oxygen (PaO2), and to evaluate pleth variability index (PVI) with stroke volume variation (SVV) or pulse pressure variation (PPV) values.
Primary Outcome
Accuracy of SpHb will be determined by comparing it to the hemoglobin value obtained from a reference blood sample and calculating the accuracy root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from SpHb value for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is
Interventions
- DEVICE Masimo Pulse CO-Oximeter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2017-03-09 |
| Est. Completion | 2017-10-11 |
What the finished NCT02841397 record still lists
NCT02841397 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Masimo Pulse CO-Oximeter is the first listed.
NCT02841397 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02841397 about?
NCT02841397 is a clinical study titled "Validation of Noninvasive Hemoglobin, Comparison of PVI to Standard Methods, and Validation of Clinical Efficacy of ORI". The study goal is to establish the correlation of hemoglobin values determined by the noninvasive pulse oximetry-determined hemoglobin (SpHb) system with hemoglobin as measured by other validated devices. The study will also evaluation oxygen reserve index (ORI) to correlate with partial pressure of...
What is the current status of trial NCT02841397?
This trial is currently completed. The enrollment target is 50 participants. The study started on 2017-03-09. Estimated completion is 2017-10-11.
What interventions are being tested in trial NCT02841397?
The interventions under investigation include: Masimo Pulse CO-Oximeter (DEVICE).
Who is sponsoring clinical trial NCT02841397?
This trial is sponsored by Masimo Corporation, which has 96 total clinical trials registered on ClinicalTrials.gov.
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