Mechanical Ventilation, Directed by Esophageal Pressure Measurements, in Patients With Acute Lung Injury

Not Applicable

Completed

• Conditions: Acute Lung Injury; Acute Respiratory Distress Syndrome

• Registration Number: NCT00127491
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2005-08-04
• Study First Submitted QC: 2005-08-04
• Study First Posted: 2005-08-08
• Primary Completion: 2007-08
• Study Completion: 2010-05
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-24
• Last Update Posted: 2017-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Oxygenation as measured by the PO2/FiO2 (P/F) ratio	72 hours from enrollment

Secondary Outcome Measures

Name	Time	Method
Ventilator free days	At 28 days
Markers of inflammation	In first 72 hours
Mortality	At 28, 90 and 180 days
Length of stay	Hospital and ICU

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States