Blood Pressure
Conditions
Keywords
The focus of this study is to demonstrate that DINAMAP® SuperSTATTM NIBP algorithm has been implemented correctly without performance losses to the B40 monitor
Brief summary
The purpose of this study is to demonstrate equivalency of the GE Healthcare B40 Patient Monitor noninvasive blood pressure (NIBP) parameter compared to the reference device.
Detailed description
Automated non-invasive blood pressure devices have a long history. These devices first made their appearance in the mid-1970's. Since that time, there have been many improvements in the performance of these devices. Specifically, when making changes to the algorithms that control these devices, the goals are: to improve accuracy and precision in the blood pressure (BP) estimates, to reduce the time needed to determine the BP estimates, to increase comfort for the patient, and to work through artifacts and arrhythmias that are often present in the clinical environment. The purpose of this study is to demonstrate equivalency of the GE Healthcare B40 Patient Monitor noninvasive blood pressure (NIBP) parameter compared to the reference device.
Interventions
DEVICEBlood Pressure Readings on B40 Patient Monitor
Simultaneous blood pressure reading on the Investigational B40 patient monitor and DINAMAP PRO1000 patient monitor
Sponsors
GE Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Ability to provide written informed consent or have a legally authorized representative including a parent or guardian provide written informed consent * Within the age range from older than 3 years old to 75 years old (adult and child) * Ability to maintain proper placement of cuff and/or probe and/or sensor
Exclusion criteria
* Neonates (ages 0-29 days) and infants (30 days to 3 years old) shall be excluded * Any subject deemed too unstable, by clinician's discretion, or for another reason deemed unacceptable for study by the clinician * Known dysrhythmias (when applicable) * Known disease state that compromises circulation to the extremity * Vigorous exercise prior to participating in the study * Excessive movement or excitability causing false values or no determinations * Known allergy to latex when latex products will be in contact with subject * Pregnant females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference Between the B40 Monitor and Reference Device DINAMAP PRO1000 on NIBP Measurements | End of each blood pressure reading | The primary endpoints are the difference in systolic, diastolic and mean blood pressure values between the B40 Monitor and PRO1000. The mean of the difference should be no more than 5mmHg and the standard deviation of the difference should be no more than 8mmHg per the AAMI SP-10 standard. |
Countries
United States
Participant flow
Recruitment details
Healthy subjects were recruited from 03.07.2012 - 03.23.2012 from Clinimark LLC, an independent physiology lab.
Pre-assignment details
Subject distribution requirements (i.e. gender, blood pressure, and arm circumference)were reviewed as part of screening prior to subject enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Blood Pressure Reading Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings | 66 |
| Total | 66 |
Baseline characteristics
| Characteristic | Blood Pressure Reading |
|---|---|
| Age, Categorical <=18 years | 17 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants |
| Age Continuous | 32 years STANDARD_DEVIATION 19.7 |
| Diastolic Blood Pressure | 73 mmHg STANDARD_DEVIATION 15.4 |
| Mean Arterial Pressure (MAP) | 92.7 mmHg STANDARD_DEVIATION 17.2 |
| Region of Enrollment United States | 66 participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 28 Participants |
| Systolic Blood Pressure | 125.0 mmHg STANDARD_DEVIATION 25.3 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 66 |
| serious Total, serious adverse events | 0 / 66 |
Outcome results
Primary
Difference Between the B40 Monitor and Reference Device DINAMAP PRO1000 on NIBP Measurements
The primary endpoints are the difference in systolic, diastolic and mean blood pressure values between the B40 Monitor and PRO1000. The mean of the difference should be no more than 5mmHg and the standard deviation of the difference should be no more than 8mmHg per the AAMI SP-10 standard.
Time frame: End of each blood pressure reading
Population: 66 subjects were enrolled. 64 subjects contributed data to the study. Subject 058 had a lateral difference of the reference diastolic blood pressure more than 10mmHg, and NIBP data was excluded from final analysis as specified in AAMI SP-10 standard. And Subject 046 had circulation issues and no data was collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| B40 and PRO1000 - Systolic BP | Difference Between the B40 Monitor and Reference Device DINAMAP PRO1000 on NIBP Measurements | -1.4 mmHg | Standard Deviation 4.8 |
| B40 and PRO1000 - Diastolic BP | Difference Between the B40 Monitor and Reference Device DINAMAP PRO1000 on NIBP Measurements | -3.3 mmHg | Standard Deviation 2.6 |
| B40 and PRO1000 - MAP | Difference Between the B40 Monitor and Reference Device DINAMAP PRO1000 on NIBP Measurements | -3.7 mmHg | Standard Deviation 4.2 |
Comparison: A total of no less than 65 subjects are needed for this study. Assuming a mean of no more than 4 mmHg and a standard deviation of no more than 5 mmHg for the difference, this sample size ensures that the percent of subjects with equivalent NIBP is at least 80% with 90% confidence. The difference between the B40 and PRO1000 patient monitors in systolic, diastolic, and mean BP determinations will be compared. A difference of within 10 mmHg is considered equivalent in NIBP.95% CI: [-2.58, -0.22]Compare the mean difference with 5mmHg
Comparison: A total of no less than 65 subjects are needed for this study. Assuming a mean of no more than 4mmHg and a standard deviation of no more than 5mmHg for the difference, this sample size ensures that the percent of subjects with equivalent NIBP is a least 80% with 90% confidence. The difference between the B40 and PRO1000 patient monitors in the systolic, diastolic, and mean BP determinations will be compared. A difference of within 10mmHg is considered equivalent in NIBP.95% CI: [-3.95, -2.66]
Comparison: A total of no less than 65 subjects are needed for this study. Assuming a mean of no more than 4mmHg and a standard deviation of no more than 5mmHg for the difference, this sample size ensures that the percent of subjects with equivalent NIBP is a least 80% with 90% confidence. The difference between the B40 and PRO1000 patient monitors in the systolic, diastolic, and mean BP determinations will be compared. A difference of within 10mmHg is considered equivalent in NIBP.95% CI: [-4.73, -2.67]