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

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ClinicalTrials.gov Identifier: NCT03897647
Recruitment Status : Not yet recruiting
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Mario Garcia, Montefiore Medical Center

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.

Condition or disease Intervention/treatment Phase
Heart Failure Acute Decompensated Heart Failure Device: General Electric (GE) VScan Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Use of POC Pocket Ultrasound in the Estimation of Left and Right Atrial Pressures
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : July 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Right atrial pressure at baseline [ Time Frame: Pressures will be estimated at baseline (within 24 hours of placement of pulmonary artery catheter upon admission to CCU) ]
    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.

  2. Right atrial pressure at 24 hours [ Time Frame: Pressures will be estimated 24 hours after 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.

  3. Right atrial pressure at 48 hours [ Time Frame: Pressures will be estimated 48 hours after 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.

  4. Left atrial pressure at baseline [ Time Frame: Pressures will be estimated at baseline (within 24 hours of placement of pulmonary artery catheter upon admission to CCU) ]
    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.

  5. Left atrial pressure at 24 hours [ Time Frame: Pressures will be estimated 24 hours after 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.

  6. Left atrial pressure at 48 hours [ Time Frame: Pressures will be estimated 48 hours after 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897647


Contacts
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Contact: Emily Ong, MD 732-609-2361 emong@montefiore.org

Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Mario Garcia, MD Montefiore Medical Center

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Responsible Party: Mario Garcia, Professor of Cardiology, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03897647     History of Changes
Other Study ID Numbers: 2017-8253
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Mario Garcia, Montefiore Medical Center:
echocardiography
pulmonary artery catheter
point of care ultrasound
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases