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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Surgery
- Sponsor
- Masimo Corporation
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Correlation of "ORI" With Partial Pressure of Oxygen (PaO2) "PaO2" Measurement From Blood Gas Analysis
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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).
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