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Boston, Massachusetts 02215


The purpose of this study is to see whether esophageal pressure (PES) measurements will allow the investigators to choose the best method of mechanical ventilation in patients with acute lung injury (ALI).

Study summary:

The current standard of practice for ventilating patients with acute respiratory distress syndrome (ARDS) is the ARDSnet protocol (N Engl J Med 2000; 342:1301-1308) which has been shown to improve survival by limiting tidal volumes and thus preventing over distention of the lungs. However, the lungs can also be damaged by under-inflation during mechanical ventilation, and current practice ignores the effects of chest wall compression of the lungs, which can cause under-inflation. The investigators have observed that a fraction of critically ill patients with apparent ARDS have lung function abnormalities caused by extrinsic compression which can be estimated by PES measurements. Changing ventilator settings to apply normal physiological pressure to the lung has been beneficial in many such patients. This protocol will formally test the clinical utility of PES measurements in patients with ARDS. This is a randomized controlled trial of therapy directed by esophageal balloon measurements (PES) versus therapy directed by ARDSnet protocol, the current standard of care.


Inclusion Criteria: Patients with ALI/ARDS according to the International Consensus Conference criteria: - PaO2/FiO2 ratio < 300 - Acute onset - Bilateral infiltrates on chest radiography - PAOP < 18 or, in patients without a pulmonary artery catheter, no other evidence of abnormal cardiac function Exclusion Criteria: - Patients with esophageal varices - Patients with esophageal trauma - Patients with recent esophageal surgery - Patients with coagulopathy (platelets < 80k or International Normalized Ratio [INR]> 2 ) - Post transplant patients - Patients with significant broncho-pleural fistula



Primary Contact:

Principal Investigator
Daniel S Talmor, MD, MPH
Beth Israel Deaconess Medical Center

Backup Contact:


Location Contact:

Boston, Massachusetts 02215
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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