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

Primary Purpose

Heart Failure, Acute Decompensated Heart Failure

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
General Electric (GE) VScan
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure focused on measuring echocardiography, pulmonary artery catheter, point of care ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    POCUS Patients

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 24, 2018
    Last Updated
    December 10, 2019
    Sponsor
    Montefiore Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03897647
    Brief Title
    Use of POC Pocket Ultrasound in the Estimation of Left and Right Atrial Pressures
    Acronym
    POCUSP
    Official Title
    Use of POC Pocket Ultrasound in the Estimation of Left and Right Atrial Pressures
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Administratively closed by the IRB
    Study Start Date
    July 31, 2019 (Anticipated)
    Primary Completion Date
    June 30, 2020 (Anticipated)
    Study Completion Date
    July 30, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Montefiore Medical Center

    4. Oversight

    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

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure, Acute Decompensated Heart Failure
    Keywords
    echocardiography, pulmonary artery catheter, point of care ultrasound

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    POCUS Patients
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    General Electric (GE) VScan
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Right atrial pressure at baseline
    Description
    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.
    Time Frame
    Pressures will be estimated at baseline (within 24 hours of placement of pulmonary artery catheter upon admission to CCU)
    Title
    Right atrial pressure at 24 hours
    Description
    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.
    Time Frame
    Pressures will be estimated 24 hours after baseline
    Title
    Right atrial pressure at 48 hours
    Description
    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.
    Time Frame
    Pressures will be estimated 48 hours after baseline
    Title
    Left atrial pressure at baseline
    Description
    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.
    Time Frame
    Pressures will be estimated at baseline (within 24 hours of placement of pulmonary artery catheter upon admission to CCU)
    Title
    Left atrial pressure at 24 hours
    Description
    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.
    Time Frame
    Pressures will be estimated 24 hours after baseline
    Title
    Left atrial pressure at 48 hours
    Description
    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.
    Time Frame
    Pressures will be estimated 48 hours after baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mario Garcia, MD
    Organizational Affiliation
    Montefiore Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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