Surgery
Conditions
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.
Interventions
DEVICEMasimo Pulse CO-Oximeter
Noninvasive pulse oximeter with various features for measurement of hemoglobin, pleth variability index, and oxygen reserve index
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Noninvasive Pulse Oximetry-determined SpHb Bias | 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 | 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 | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Group All subjects will be enrolled into the test group and will receive Masimo Pulse CO-Oximeter for measurement of various physiological parameters.
Masimo Pulse CO-Oximeter: Noninvasive pulse oximeter with various features for measurement of hemoglobin, pleth variability index, and oxygen reserve index | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Test Group | — |
|---|---|---|
| Age, Categorical <=18 years | 1 Participants | — |
| Age, Categorical >=65 years | 17 Participants | — |
| Age, Categorical Between 18 and 65 years | 30 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 48 participants | — |
| Sex: Female, Male Female | 26 Participants | — |
| Sex: Female, Male Male | 22 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
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.
Population: Data from 8 subjects were obtained. At least two samples per subject are required to compare ORI trending ability; however, only 1 sample was obtained from each subject which precluded conduct of any data analysis.
Primary
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.
Population: There was no reference SVV or PPV data available for PVI data analysis.
Primary
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.
Population: A total of 12 subjects were excluded from data analysis Subjects were excluded from data analysis for different reasons. Reason 1: Blood sample could not be analyzed because received out of analyzer required time window Reason 2: Sensor data is not available Reason 3: No time matched sensor and blood sample data pair for analysis Reason 4: Reference tHb error. tHb difference \>1g/dL between different methods
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test Group | Noninvasive Pulse Oximetry-determined SpHb Bias | 0.9 g/dL |