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The purpose of this study is to establish the performance of a blood pressure cuff. The hypothesis is that the blood pressure reading from the cuff will provide similar blood pressure as a radial artery.
Blood pressure reading from the cuff will provide similar blood pressure as a radial artery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood Pressure monitoring | Other | Blood Pressure (BP) monitoring using invasive arterial insertion as a standard reference, and an investigational, non-invasive blood pressure (NIBP) monitoring cuff. Data obtained from the cuff used the SuperSTAT NIBP algorithm and the Classic NIBP algorithm for output. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BP monitoring using two methods | Device | BP readings from participant using invasive radial arterial line, Non-invasive cuff with SuperSTAT NIBP algorithm, and Non-invasive cuff with Classic NIBP algorithm. |
| Measure | Description | Time Frame |
|---|---|---|
| Performance Comparison: NIBP Forearm Cuff Using SuperStat Algorithm vs. Invasive Radial Blood Pressure Reading | NIBP Forearm cuff systolic and diastolic values using SuperStat algorithm compared to invasive radial blood pressure systolic and diastolic values (both obtained simultaneously). | Approximately 2 hours |
| Performance Comparison: NIBP Forearm Cuff Using Classic Algorithm vs. Invasive Radial Blood Pressure Reading | NIBP Forearm cuff systolic and diastolic values using Classic algorithm difference compared to invasive radial blood pressure readings (both readings obtained simultaneously). | Approximately 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Ransom, MD | Clinimark, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinimark | Louisville | Colorado | 80027 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Blood Pressure Monitoring | Participants with blood pressure monitored using invasive and non-invasive methods. Blood pressure monitoring will take place with both devices simultaneously. The invasive "gold standard" device is a radial arterial catheter connected to the DASH 4000, while the non-invasive device is the Soft-Cuf connected to the DASH 4000 Patient Bedside Monitor with SuperSTAT NIBP software, or same with the Classic NIBP algorithm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Blood Pressure Monitoring | Blood Pressure Monitoring using two methods: invasive radial line insertion and non-invasive blood pressure cuff |
| Units | Counts |
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| Participants |
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| 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 | Performance Comparison: NIBP Forearm Cuff Using SuperStat Algorithm vs. Invasive Radial Blood Pressure Reading | NIBP Forearm cuff systolic and diastolic values using SuperStat algorithm compared to invasive radial blood pressure systolic and diastolic values (both obtained simultaneously). | Blood Pressure (BP) monitoring using invasive arterial insertion as a standard reference, and an investigational, non-invasive blood pressure (NIBP) monitoring cuff. Data obtained from the cuff used the SuperStat algorithm for output. | Posted | Mean | Standard Deviation | mmHg | Approximately 2 hours |
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2 weeks
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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 Monitoring | All participants enrolled in the study | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeff Conner | GE Healthcare | 414-721-2423 |
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| Participants |
| No |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Performance Comparison: NIBP Forearm Cuff Using Classic Algorithm vs. Invasive Radial Blood Pressure Reading | NIBP Forearm cuff systolic and diastolic values using Classic algorithm difference compared to invasive radial blood pressure readings (both readings obtained simultaneously). | Blood Pressure (BP) monitoring using invasive arterial insertion as a standard reference, and an investigational, non-invasive blood pressure (NIBP) monitoring cuff. Data obtained from the cuff used the Classic NIBP algorithm for output. | Posted | Mean | Standard Deviation | mmHg | Approximately 2 hours |
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