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

NCT ID: NCT03897647

Last Updated: 2019-12-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-31
• Study Completion Date: 2020-07-30

Brief Summary

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.

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.

Conditions

Heart Failure; Acute Decompensated Heart Failure

Keywords

echocardiography; pulmonary artery catheter; point of care ultrasound

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

General Electric (GE) VScan

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mario Garcia, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Other Identifiers

2017-8253

Identifier Type: -

Identifier Source: org_study_id