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.
Brief Title
Use of POC Pocket Ultrasound in the Estimation of Left and Right Atrial Pressures
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.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Heart Failure
Acute Decompensated Heart Failure
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.
* 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.
Inclusion 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.
* 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.
Gender
All
Gender Based
false
Keywords
echocardiography
pulmonary artery catheter
point of care ultrasound
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03897647
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2017-8253
Overall Status
Withdrawn
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Use of POC Pocket Ultrasound in the Estimation of Left and Right Atrial Pressures
Primary Outcomes
Outcome 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.
Outcome Measure
Right atrial pressure at baseline
Outcome Time Frame
Pressures will be estimated at baseline (within 24 hours of placement of pulmonary artery catheter upon admission to CCU)
Outcome 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.
Outcome Measure
Right atrial pressure at 24 hours
Outcome Time Frame
Pressures will be estimated 24 hours after baseline
Outcome 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.
Outcome Measure
Right atrial pressure at 48 hours
Outcome Time Frame
Pressures will be estimated 48 hours after baseline
Outcome 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.
Outcome Measure
Left atrial pressure at baseline
Outcome Time Frame
Pressures will be estimated at baseline (within 24 hours of placement of pulmonary artery catheter upon admission to CCU)
Outcome 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.
Outcome Measure
Left atrial pressure at 24 hours
Outcome Time Frame
Pressures will be estimated 24 hours after baseline
Outcome 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.
Outcome Measure
Left atrial pressure at 48 hours
Outcome Time Frame
Pressures will be estimated 48 hours after baseline
Start Date
Start Date Type
Estimated
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Mario Garcia
Investigator Email
mariogar@montefiore.org
Investigator Phone
718-920-4172