The Relationship Between Positive End Expiratory Pressure and Cardiac Index in Patients With Acute Respiratory Distress Syndrome (ARDS) Managed on a Fluid Protocol

NCT01714583 | Completed

• 1 other identifier: NHLBI T32 HL007106-34
• Study Type: observational
• Target: 367
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Keywords

Mechanical ventilation; ARDS; acute lung injury; cardiac function; cardiac index; heart-lung interaction

Outcome Measures

Primary Outcomes (1)

• Cardiac Index

  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.

  Cross sectional (i.e. at time Zero only)

Study Arms (2)

High PEEP

Cohort of participants with positive end-expiratory pressure (PEEP) greater than or equal to 12cm.

Low PEEP

Cohort of participants with positive end-expiratory pressure (PEEP) less than 12cm.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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. We 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.

You may qualify if:

• Acute lung injury diagnosis (as defined by The American - European Consensus Conference on ARDS) of \< 48 hours in duration.
• Patients in the Pulmonary Artery catheter (PAC) arm of the FACTT study. PaO2 / FiO2 ratio of \< 200. Data from the first 3 days of mechanical ventilation.

You may not qualify if:

• Select chronic conditions that could independently influence survival (e.g., expected 6-month survival \< 50%) and / or ventilator weaning.
• PEEP values missing. FiO2 values missing. PaO2 values missing. Cardiac index values missing Pressors and / or inotropes requirement.

Sponsors & Collaborators

• Yale University: lead
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

Yale University, School of Medicine, Department of Internal Medicine, Section of Pulmonary and Critical Care Medicine

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

• Fares WH, Carson SS; NIH NHLBI ARDS Network. The relationship between positive end-expiratory pressure and cardiac index in patients with acute respiratory distress syndrome. J Crit Care. 2013 Dec;28(6):992-7. doi: 10.1016/j.jcrc.2013.06.021. Epub 2013 Aug 28.

  PMID: 23993772 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Injury

Study Officials

• Wassim H Fares, MD MSc

  Yale University, School of Medicine, Department of Internal Medicine, Section of Pulmonary and Critical Care Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2012
• First Posted: October 26, 2012
• Study Start: April 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 26, 2012

Record last verified: 2012-10

Locations

US (1)