Atrial Fibrillation, Decompensated Congestive Heart Failure, Distributive Shock, High Risk Non-cardiac Surgery, Hypotension and Shock, Systemic Inflammatory Response Syndrome
Conditions
Brief summary
The aim of this study is to determine the effects of fluid alternations, hemodynamic changes, mechanical ventilation, pharmacologic agents, positional changes, and comorbidities on the Peripheral Intravenous waveform Analysis (PIVA) signal.
Detailed description
Intravascular volume status determination remains elusive. Standard vital sign monitoring, including heart rate and blood pressure, fails to detect intravascular volume depletion and volume overload. Likewise, invasive monitoring is fraught with risk including vascular injury and central line associated infections. As such, a minimally-invasive mechanism to overcome the barriers of standard monitoring to detect volume status derangement, would be highly valuable. The goal of the study is to perform a series of observational feasibility studies in healthy and hospitalized subjects to determine effects of fluid alternations, hemodynamic changes, mechanical ventilation, pharmacologic agents, positional changes, and comorbidities on the PIVA signal
Interventions
Non-invasive measurement of peripheral venous waveform analysis (PIVA) obtained by connecting a standard transducer (AD Instruments, Colorado Springs, Co) to a universal adaptor or stopcock on a peripheral IV
PROCEDUREStandard of care invasive vascular monitoring
Standard of care invasive monitoring in the intensive care settings with central venous catheters, pulmonary artery catheters, or trans-esophageal echocardiography for determining volume status.
PROCEDUREStandard noninvasive vascular monitoring
Standard noninvasive vascular monitoring of blood pressure, pulse rate, pulse oximetry and respiratory rate.
Sponsors
Baxter Healthcare Corporation
Vanderbilt University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Cardiac Catheterization Inclusion criteria: * Patients undergoing right heart catheterization or left and right heart catheterizaton; Age \>=18
Exclusion criteria
* Cardiac assist devices (intra-aortic balloon pump, ventricular assist devices, and extra corporeal membrane oxygenation), ongoing ACLS, aortic or mitral valve disease greater than mild in severity, aortic or mitral valve replacement, active irregular heart rhythm, patients with restrictive cardiomyopathies (cardiac amyloidosis), constrictive cardiac disease (constrictive pericarditis or cardiac-tamponade), congenital heart disease other than foramen ovale, repaired atrial or ventricular septal defect, female patients who are pregnant or lactating, or patients with known psychiatric or neurological disease who are unable to consent. Patients who do not have a functional peripheral IV as part of standard care. Pressors, starches, lipids, propofol, or D10 or higher running through the PIVA line. Distributive Shock Inclusion Criteria: * Cardiopulmonary bypass for cardiac procedures within one hour of arriving in the ICU post-op; Age \>=18
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of PIVA score to standard hemodynamic monitors | Baseline to end of monitoring (Approximately 180 minutes) | Peripheral intravenous waveform analysis score is used to detect intravascular volume status. The scale ranges from 2-40 and is interpreted as a surrogate for pulmonary capillary wedge pressure. The normal scale range is 6-12. A PIVA score of 2 indicates a low intravascular volume and 40 indicates a high intravascular volume. |
Countries
United States
Outcome results
None listed