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

Beth Israel Deaconess Medical Center63 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Lung Injury Acute Respiratory Distress Syndrome

Interventions

Placement of an esophageal balloon measurementsPROCEDURE

In both groups an esophageal balloon will be placed and baseline measurements recorded. In the EP group the mechanical ventilation settings will be determined based on these measurements. In the control group measurements will be recorded but ventilation will be based in the existing standard of care wich is the ARDSnet low tidal volume ventilation study. measurements will be repeated at 24, 48 and 72 hours or as needed.

Low tidal volume ventilationOTHER

Low tidal volume ventilation strategy (ARDSnet)

Transpulmonary pressure-directed ventilation (EPVent)OTHER

Transpulmonary pressure-directed ventilation using measurements from the esophageal balloon.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Oxygenation as measured by the PO2/FiO2 (P/F) ratio

Time frame: 72 hours from enrollment

Secondary Outcomes

Ventilator free days

Time frame: At 28 days

Markers of inflammation

Time frame: In first 72 hours

Mortality

Time frame: At 28, 90 and 180 days

Length of stay

Time frame: Hospital and ICU

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.