Viewing Study NCT00127491



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Study NCT ID: NCT00127491
Status: COMPLETED
Last Update Posted: 2017-02-27
First Post: 2005-08-04

Brief Title: Mechanical Ventilation Directed by Esophageal Pressure Measurements in Patients With Acute Lung Injury
Sponsor: Beth Israel Deaconess Medical Center
Organization: Beth Israel Deaconess Medical Center

Study Overview

Official Title: A RCT of Mechanical Ventilation Directed by Esophageal Pressure Measurements in Patients With Acute Lung Injury
Status: COMPLETED
Status Verified Date: 2017-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 3421301-1308 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01HL052586 NIH None httpsreporternihgovquickSearchR01HL052586