The Relationship Between Positive End Expiratory Pressure and Cardiac Index in Patients With Acute Respiratory Distress Syndrome (ARDS) Managed on a Fluid Protocol
The objective of this study is to evaluate the association between positive end-expiratory pressure (PEEP) setting and cardiac function, as measured by cardiac index, in patients with acute respiratory distress syndrome (ARDS) who were managed on the NHLBI ARDS Network Fluid and Catheter Treatment Trial (FACTT) fluid protocols.
Acute Respiratory Distress Syndrome (ARDS)
|Study Design:||Time Perspective: Retrospective|
|Official Title:||The Relationship Between Positive End Expiratory Pressure and Cardiac Index in Patients With ARDS Managed on a Fluid Protocol: A Secondary Analysis of a Prospective Trial|
- Cardiac Index [ Time Frame: Cross sectional (i.e. at time Zero only) ] [ Designated as safety issue: No ]
The cardiac index is a cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area to yield the cardiac index.
The cardiac index which is the outcome measure is assessed at the same time as the PEEP (which is the independent variable) is measured.
The study participants are NOT followed for any period of time. This is a cross-sectional study design. Both variables (Cardiac index and PEEP) are measured at the same time.
|Study Start Date:||April 2011|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Cohort of participants with positive end-expiratory pressure (PEEP) greater than or equal to 12cm.
Cohort of participants with positive end-expiratory pressure (PEEP) less than 12cm.
This is a secondary cross-sectional analysis of the FACTT multi-center randomized controlled trial enrolling adult patients within 48 hours of ARDS onset from twenty medical centers across the US, some of which included more than one hospital. We studied the patients who were randomized to the pulmonary artery catheter arm of the FACTT study. The investigators included patients that had PEEP and cardiac index measurements performed within a short period of each other during the first 3 days of the FACTT study enrollment. Since FACTT had a 2x2 factorial design, half of the patients were in a 'liberal fluids' study arm, and the other half were in a 'conservative fluids' study arm.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01714583
|United States, Connecticut|
|Yale University, School of Medicine, Department of Internal Medicine, Section of Pulmonary and Critical Care Medicine|
|New Haven, Connecticut, United States, 06510|
|Principal Investigator:||Wassim H Fares, MD MSc||Yale University, School of Medicine, Department of Internal Medicine, Section of Pulmonary and Critical Care Medicine|