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This study will compare accuracy of a newly developed monitor for continuous non-invasive blood pressure monitoring (CNAP™ Monitor 500; CNSystems Medizintechnik AG, Graz, Austria) that provides beat-to-beat BP readings with two of the current and more commonly used intermittently oscillometric non-invasive blood pressure device (NIBP), and the invasive arterial line (IBP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CNAP monitor | Experimental | Subjects undergoing bariatric surgery and monitored using the CNAP monitor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CNAP monitor | Device | Patients undergoing bariatric surgery and being monitored using the CNAP monitor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Absolute Difference in Mean Arterial Pressure Between the Arterial Catheter and the CNAP. | To avoid biasing the data, the absolute, not directional, difference was used. For example, if the reading from the CNAP device was 10 mmHg above or below the reading from the AC, a value of 10 mmHg was used, not -10 or +10 mmHg. | Participants will be followed for the duration of surgery, an expected average of 2 hours. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph D Tobias, MD | Nationwide Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | CNAP Monitor | Subjects undergoing bariatric surgery and monitored using the CNAP monitor. CNAP monitor: Patients undergoing bariatric surgery and being monitored using the CNAP monitor. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | CNAP Monitor | Subjects undergoing bariatric surgery and monitored using the CNAP monitor. CNAP monitor: Patients undergoing bariatric surgery and being monitored using the CNAP monitor. |
| Units | Counts |
|---|---|
| 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 | The Absolute Difference in Mean Arterial Pressure Between the Arterial Catheter and the CNAP. | To avoid biasing the data, the absolute, not directional, difference was used. For example, if the reading from the CNAP device was 10 mmHg above or below the reading from the AC, a value of 10 mmHg was used, not -10 or +10 mmHg. | The initial study cohort included 21 patients; however, the finger cuff was expired in 1 patient, resulting in no data collection, and the data from 2 other patients were lost in the download to the electronic medical record system. | Posted | Mean | Standard Deviation | mmHg | Participants will be followed for the duration of surgery, an expected average of 2 hours. |
|
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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 | CNAP Monitor | Subjects undergoing bariatric surgery and monitored using the CNAP monitor. CNAP monitor: Patients undergoing bariatric surgery and being monitored using the CNAP monitor. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph D. Tobias, MD | Nationwide Children's Hospital | 6147224200 | Joseph.Tobias@nationwidechildrens.org |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 21 |
| 0 |
| 21 |
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