Trial Outcomes & Findings for Validation of Noninvasive Hemoglobin, Comparison of PVI to Standard Methods, and Validation of Clinical Efficacy of ORI (NCT NCT02841397)
NCT ID: NCT02841397
Last Updated: 2021-10-21
Results Overview
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.
COMPLETED
50 participants
Duration of study participation is up to three days.
2021-10-21
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
48
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
There were four subjects that did not complete the study.
Baseline characteristics by cohort
| Measure |
Test Group
n=50 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=48 Participants • There were four subjects that did not complete the study.
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=48 Participants • There were four subjects that did not complete the study.
|
|
Age, Categorical
>=65 years
|
17 Participants
n=48 Participants • There were four subjects that did not complete the study.
|
|
Sex: Female, Male
Female
|
26 Participants
n=48 Participants • Please see reasons provided above.
|
|
Sex: Female, Male
Male
|
22 Participants
n=48 Participants • Please see reasons provided above.
|
|
Region of Enrollment
United States
|
48 participants
n=48 Participants • Please see reasoning above.
|
PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Test Group
n=34 Participants
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
|
|---|---|
|
Noninvasive Pulse Oximetry-determined SpHb Bias
|
0.9 g/dL
|
PRIMARY outcome
Timeframe: Duration of study participation is up to three days.Population: There was no reference SVV or PPV data available for PVI data analysis.
Correlation of PVI measurement compared with pulse pressure variation PPV or stroke volume variation (SVV) measurement from arterial catheter
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 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.
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).
Outcome measures
Outcome data not reported
Adverse Events
Test Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60