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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood Pressure Reading | Experimental | Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Pressure Readings on B40 Patient Monitor | Device | Simultaneous blood pressure reading on the Investigational B40 patient monitor and DINAMAP PRO1000 patient monitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | End of each blood pressure reading |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinimark | Louisville | Colorado | 80027 | United States |
Subject distribution requirements (i.e. gender, blood pressure, and arm circumference)were reviewed as part of screening prior to subject enrollment.
Healthy subjects were recruited from 03.07.2012 - 03.23.2012 from Clinimark LLC, an independent physiology lab.
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| ID | Title | Description |
|---|---|---|
| FG000 | Blood Pressure Reading | Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Blood Pressure Reading | Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | mmHg | End of each blood pressure reading |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Blood Pressure Reading | Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Conner - Global Research Manager | GE Healthcare | 414.721.2423 | Jeffrey.Conner@ge.com |
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Mean Arterial Pressure (MAP) | Mean | Standard Deviation | mmHg |
|
| OG001 | B40 and PRO1000 - Diastolic BP |
| OG002 | B40 and PRO1000 - MAP |
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| 0 |
| 66 |
| 0 |
| 66 |
The sponsor cannot require changes to the PI's disclosure, with the exception of requesting the removal of sponsor's confidential information. The study results themselves are not considered confidential information. Sponsor cannot extend the embargo beyond 60 days unless the PI's disclosure contains patentable subject matter, in which an embargo beyond 60 days may be necessary to allow for the filing of a patent application