Clinical trial NCT03897647: Use of POC Pocket Ultrasound in the Estimation of Left and Right Atrial Pressures
Official title: Use of POC Pocket Ultrasound in the Estimation of Left and Right Atrial Pressures
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Heart Failure
Acute Decompensated Heart Failure
Keywords: echocardiography
pulmonary artery catheter
point of care ultrasound
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2019-04-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Right atrial pressure at baseline
timeFrame: Pressures will be estimated at baseline (within 24 hours of placement of pulmonary artery catheter upon admission to CCU)
measure: Right atrial pressure at 24 hours
timeFrame: Pressures will be estimated 24 hours after baseline
measure: Right atrial pressure at 48 hours
timeFrame: Pressures will be estimated 48 hours after baseline
measure: Left atrial pressure at baseline
timeFrame: Pressures will be estimated at baseline (within 24 hours of placement of pulmonary artery catheter upon admission to CCU)
measure: Left atrial pressure at 24 hours
timeFrame: Pressures will be estimated 24 hours after baseline
measure: Left atrial pressure at 48 hours
timeFrame: Pressures will be estimated 48 hours after baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Montefiore Medical Center
name: Mario Garcia, MD
role: PRINCIPAL_INVESTIGATOR
References: