NCT00127491

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Lung Injury
• Acute Respiratory Distress Syndrome

Interventions

Type	Name	Description
PROCEDURE	Placement of an esophageal balloon measurements	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.
OTHER	Low tidal volume ventilation	Low tidal volume ventilation strategy (ARDSnet)
OTHER	Transpulmonary pressure-directed ventilation (EPVent)	Transpulmonary pressure-directed ventilation using measurements from the esophageal balloon.

Timeline

• Start date: 2004-05-01
• Primary completion: 2007-08-01
• Completion: 2010-05-01
• First posted: 2005-08-08
• Last updated: 2017-02-27

Locations

1 site across 1 country: United States