Validation of Noninvasive Hemoglobin, Comparison of PVI to Standard Methods, and Validation of Clinical Efficacy of ORI

Masimo Corporation50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Surgery

Interventions

Masimo Pulse CO-OximeterDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Admitted into the ICU * Aged 18 years or older * Mechanically ventilated * Arterial line placed * Vigileo/Flotrac System being used for guidance of fluid management Exclusion Criteria: * Pregnancy * Prisoner status * Extreme hemodynamic instability * Multiple vasopressors in use with questionable peripheral blood flow * Lack of appropriate sites for sensor placement * Patient or patient's legal representative refusal

Locations (1)

Loma Linda University Medical Center

Loma Linda, California, United States

Outcomes

Primary Outcomes

Noninvasive Pulse Oximetry-determined SpHb Bias

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 computed as the Arms Error value.

Time frame: Duration of study participation is up to three days.

Correlation of PVI Measurement Compared With PPV or SVV

Correlation of PVI measurement compared with pulse pressure variation PPV or stroke volume variation (SVV) measurement from arterial catheter

Time frame: Duration of study participation is up to three days.

Correlation of "ORI" With Partial Pressure of Oxygen (PaO2) "PaO2" Measurement From Blood Gas Analysis

Concordance will be determined by comparing the trending ability of the Oxygen Reserve Index (ORI) measurement of the sensor with that of Partial Pressure of Oxygen in Blood (PaO2).

Time frame: Duration of study participation is up to three days.

Data from ClinicalTrials.gov

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