Use of POC Pocket Ultrasound in the Estimation of Left and Right Atrial Pressures (POCUSP)

This study will assess the reliability of POC ultrasound in estimating right and left atrium pressures in patients with acute decompensated heart failure. This study will compare hemodynamic measurements obtained from pulmonary artery catheters with those estimated from POC ultrasound using inferior vena cava (IVC) measurements and the presence of atrial septal bulge.

Study Overview

• Status: Withdrawn
• Conditions: Heart Failure; Acute Decompensated Heart Failure
• Intervention / Treatment: Device: General Electric (GE) VScan

Detailed Description

For those patients admitted to the CCU who have pulmonary artery catheters placed by the primary team as part of their medical care, the investigators will collect hemodynamic data from their pulmonary artery catheters and echocardiographic data. Echocardiographic and hemodynamic data obtained from pulmonary artery catheters will be simultaneously collected at baseline (within 24 hours of catheter placement) and after 24 and 48 hours of intensive medical therapy if the pulmonary artery catheter is still in place at those times. The placement of the pulmonary artery catheter and the taking of hemodynamic measurements from the catheter will be done as per the primary medical team. The research team will not place any pulmonary artery catheters.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with advanced systolic heart failure (as defined by left ventricular ejection fraction of less than or equal to 35% and New York Heart Association Class III to IV symptoms) who are admitted to the CCU and require hemodynamic monitoring with a Swan-Ganz catheter.

Exclusion Criteria:

• Patients supported by mechanical ventilation (intubation or positive pressure ventilation)
• Patients requiring temporary mechanical circulatory support devices (intra-aortic balloon pump, Impella, CentriMag, extracorporeal membrane oxygenation)
• Patients requiring permanent mechanical circulatory support devices (right or left ventricular assist devices)
• Post-cardiac transplantation patients.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: POCUS Patients; A bedside echocardiogram will be taken using a point-of-care pocket ultrasound (General Electric (GE) Vscan). Central venous pressure (right atrial pressure) and pulmonary capillary wedge pressure (left atrial pressure) will be collected from pulmonary artery catheters.	Device: General Electric (GE) VScan; This is a small, point-of-care, hand-held device used for ultrasound (POCUS). It uses sound waves to generate images without using any radiation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Right atrial pressure at baseline	Right atrial pressure is the pressure in one of the chambers of the heart (the right atrium). It reflects the amount of blood returning to the heart. Normal right atrial pressure is 5 to 10 mm Hg. Low pressures indicate that less blood is returning to the heart than normal, higher pressures indicate that more blood is returning to the heart than normal. Higher pressures can occur for example, in patients with heart failure who are fluid overloaded.	Pressures will be estimated at baseline (within 24 hours of placement of pulmonary artery catheter upon admission to CCU)
Right atrial pressure at 24 hours	Right atrial pressure is the pressure in one of the chambers of the heart (the right atrium). It reflects the amount of blood returning to the heart. Normal right atrial pressure is 5 to 10 mm Hg. Low pressures indicate that less blood is returning to the heart than normal, higher pressures indicate that more blood is returning to the heart than normal. Higher pressures can occur for example, in patients with heart failure who are fluid overloaded.	Pressures will be estimated 24 hours after baseline
Right atrial pressure at 48 hours	Right atrial pressure is the pressure in one of the chambers of the heart (the right atrium). It reflects the amount of blood returning to the heart. Normal right atrial pressure is 5 to 10 mm Hg. Low pressures indicate that less blood is returning to the heart than normal, higher pressures indicate that more blood is returning to the heart than normal. Higher pressures can occur for example, in patients with heart failure who are fluid overloaded.	Pressures will be estimated 48 hours after baseline
Left atrial pressure at baseline	Left atrial pressure is the pressure in one of the chambers of the heart (the left atrium). It represents the filling pressure of the left side of the heart before blood is pumped to the rest of the body. Normal left atrial pressure is 6 to 12 mm Hg. In patients with heart failure, the left atrial pressure may be high due to the heart failing to effectively pump blood to the rest of the body.	Pressures will be estimated at baseline (within 24 hours of placement of pulmonary artery catheter upon admission to CCU)
Left atrial pressure at 24 hours	Left atrial pressure is the pressure in one of the chambers of the heart (the left atrium). It represents the filling pressure of the left side of the heart before blood is pumped to the rest of the body. Normal left atrial pressure is 6 to 12 mm Hg. In patients with heart failure, the left atrial pressure may be high due to the heart failing to effectively pump blood to the rest of the body.	Pressures will be estimated 24 hours after baseline
Left atrial pressure at 48 hours	Left atrial pressure is the pressure in one of the chambers of the heart (the left atrium). It represents the filling pressure of the left side of the heart before blood is pumped to the rest of the body. Normal left atrial pressure is 6 to 12 mm Hg. In patients with heart failure, the left atrial pressure may be high due to the heart failing to effectively pump blood to the rest of the body.	Pressures will be estimated 48 hours after baseline

Collaborators and Investigators

• Sponsor: Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): July 31, 2019
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): July 30, 2020

Study Registration Dates

• First Submitted: May 24, 2018
• First Submitted That Met QC Criteria: March 28, 2019
• First Posted (Actual): April 1, 2019

Study Record Updates

• Last Update Posted (Actual): December 12, 2019
• Last Update Submitted That Met QC Criteria: December 10, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: echocardiography; pulmonary artery catheter; point of care ultrasound
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2017-8253

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes