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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Surgery

Intervention / Treatment
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* Device: Masimo Pulse CO-Oximeter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>All subjects will be enrolled into the test group and will receive Masimo Pulse CO-Oximeter for measurement of various physiological parameters. | Device: Masimo Pulse CO-Oximeter<br>* Noninvasive pulse oximeter with various features for measurement of hemoglobin, pleth variability index, and oxygen reserve index<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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). | Duration of study participation is up to three days. |