Peripheral Venous Analysis (PIVA) for Predicting Volume Responsiveness and Fluid Status

Vanderbilt University Medical Center

Status: Terminated

Conditions: High Risk Non-cardiac Surgery; Atrial Fibrillation; Distributive Shock; Decompensated Congestive Heart Failure; Systemic Inflammatory Response Syndrome; Hypotension and Shock

Treatments: Procedure: Peripheral Intravenous Analysis (PIVA); Procedure: Standard noninvasive vascular monitoring; Procedure: Standard of care invasive vascular monitoring

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03407287

828397

Details and patient eligibility

About

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.

Full 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

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Exclusion Criteria:

• Cardiac assist devices (intra-aortic balloon pump, ventricular assist devices, and extracorporeal membrane oxygenation), ongoing ACLS, severe tricuspid regurgitation or stenosis, patient with restrictive cardiomyopathies (cardiac amyloidosis), patients receiving pulmonary vasodilators (nitric oxide, sodium nitroprusside, sildenafil), atrial fibrillation, congenital heart disease, 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.

Vasoactive and Inotropic Agents

Inclusion Criteria:

• Hospitalized patients with central venous access and pulmonary arterial catheter in place, requiring infusion of vasoactive and/or inotropic agents; Age >=18

Exclusion Criteria:

• Cardiac assist devices (intra-aortic balloon pump, ventricular assist devices, and extracorporeal membrane oxygenation), ongoing ACLS, severe tricuspid regurgitation or stenosis, patient with restrictive cardiomyopathies (cardiac amyloidosis), patients receiving pulmonary vasodilators (nitric oxide, sodium nitroprusside, sildenafil), atrial fibrillation, congenital heart disease, 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.

Congestive Heart Failure

Inclusion Criteria:

• Patients presenting to Vanderbilt University Medical Center with the diagnosis of congestive heart failure and present with symptoms of fluid overload; Age>=18

Exclusion Criteria:

• Cardiac assist devices (intra-aortic balloon pump, ventricular assist devices, and extra corporeal membrane oxygenation), ongoing ACLS, active irregular heart rhythm, patient with restrictive cardiomyopathies (cardiac amyloidosis), or 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.

Atrial Fibrillation (undergoing elective direct current cardio version)

Inclusion Criteria:

• Patients with atrial fibrillation undergoing direct current cardioversion; Age >=18

Exclusion Criteria:

• Cardiac assist devices (intra-aortic balloon pump, ventricular assist devices, and extra corporeal membrane oxygenation), ongoing ACLS, patients with restrictive cardiomyopathies (cardiac amyloidosis) or 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.

Patients undergoing Surgery

Inclusion Criteria:

• Patients presenting for surgery requiring positive pressure ventilation and arterial line placement; Age >=18

Exclusion Criteria:

• Cardiac assist devices (intra-aortic balloon pump, ventricular assist devices, and extra corporeal membrane oxygenation), ongoing ACLS, patients with restrictive cardiomyopathies (cardiac amyloidosis) or constrictive cardiac disease (constrictive pericarditis or cardiac tamponade), active irregular cardiac rhythm, congenital heart disease other than foramen ovale , repaired atrial or ventricular septal defect, female patients who are pregnant or lactating, patients with known psychiatric or neurological disease who are unable to consent, or any other medical condition which, in the opinion of the investigator, would place the patient at undue risk from participation in the trial. Patients who do not have a functional peripheral IV as part of standard care.

Trial design

180 participants in 6 patient groups

Cardiac Catheterization

Treatment:

Procedure: Peripheral Intravenous Analysis (PIVA)

Procedure: Standard noninvasive vascular monitoring

Procedure: Standard of care invasive vascular monitoring

Distributive shock

Treatment:

Procedure: Peripheral Intravenous Analysis (PIVA)

Procedure: Standard noninvasive vascular monitoring

Procedure: Standard of care invasive vascular monitoring

Vasoactive and inotropic agents

Treatment:

Procedure: Peripheral Intravenous Analysis (PIVA)

Procedure: Standard noninvasive vascular monitoring

Procedure: Standard of care invasive vascular monitoring

Congestive heart failure

Treatment:

Procedure: Peripheral Intravenous Analysis (PIVA)

Procedure: Standard noninvasive vascular monitoring

Procedure: Standard of care invasive vascular monitoring

Atrial fibrillation

Description:

Patients with atrial fibrillation undergoing elective direct current cardioversion

Treatment:

Procedure: Peripheral Intravenous Analysis (PIVA)

Procedure: Standard noninvasive vascular monitoring

Procedure: Standard of care invasive vascular monitoring

Patients undergoing surgery

Description:

Patients undergoing surgery requiring positive pressure ventilation and arterial line placement

Treatment:

Procedure: Peripheral Intravenous Analysis (PIVA)

Procedure: Standard noninvasive vascular monitoring

Procedure: Standard of care invasive vascular monitoring