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A before and after interventional cohort study comparing intermittent blood pressure measurement using the oscillometric arm cuff to continuous noninvasive blood pressure (cNIBP) measurement using the VitaWave finger cuffs in subjects undergoing elective surgery in an outpatient setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 - Standard of Care | Experimental | Study device data are blinded to the provider |
|
| Cohort 2 - Standard of Care with cNIBP Monitoring | Experimental | Study device continuous non-invasive blood pressure data are unblinded to the provider |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HemoSphere Vita Monitor with VitaWave or VitaWave Plus Finger Cuff Adult, and ForeSight Large Sensors | Device | Devices are applied for monitoring throughout the duration of the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of adult patients undergoing elective noncardiac surgery in the outpatient setting who experience hypotension, defined as a mean arterial pressure (MAP) < 65 mmHg, for a total duration of at least 5 minutes. | Through Study Completion, approximately 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cristina Johnson | Contact | 949-308-5850 | APMContinuity.Study@bd.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Recruiting | Rochester | New York | 14620 | United States |
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