CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Masimo Pulse CO-Oximeterdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02841397
NCT02841397N/ACompleted

Validation of a Pulse Oximetry Based Hemoglobin Measurement System. Comparison of Plethysmographic Variability Index to Standard Methods of Guiding Fluid and Transfusion Management in the Critically Ill Adult Patients. Validation of Clinical Efficacy of ORI for Supplemental Oxygen Titration

Masimo Corporation·interventional·Posted Jul 22, 2016·Updated Oct 21, 2021

In Brief

A clinical study evaluating Masimo Pulse CO-Oximeter for Surgery. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSurgery
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJul 22, 2016
Enrollment StartMar 9, 2017
Primary CompletionOct 11, 2017
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 9.9 years ago

Interventions

Masimo Pulse CO-Oximeterdevice

Noninvasive pulse oximeter with various features for measurement of hemoglobin, pleth variability index, and oxygen reserve index