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 oxygen (PaO2), and to evaluate pleth variability index (PVI) with stroke volume variation (SVV) or pulse pressure variation (PPV) values.

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Key information

Conditions

Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Primary location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Masimo Pulse CO-Oximeter

Device

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

Primary outcomes

Noninvasive Pulse Oximetry-determined SpHb Bias

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

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.
Correlation of PVI Measurement Compared With PPV or SVV

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

Correlation of PVI measurement compared with pulse pressure variation PPV or stroke volume variation (SVV) measurement from arterial catheter
Correlation of "ORI" With Partial Pressure of Oxygen (PaO2) "PaO2" Measurement From Blood Gas Analysis

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

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).

Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Jul 22, 2016
Registry last updated: Oct 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed