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Sponsors and Collaborators: |
Beth Israel Deaconess Medical Center National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | Beth Israel Deaconess Medical Center |
ClinicalTrials.gov Identifier: | NCT00127491 |
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).
Condition | Intervention | Phase |
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Acute Lung Injury Acute Respiratory Distress Syndrome |
Procedure: Placement of an esophageal balloon measurements |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | A RCT of Mechanical Ventilation, Directed by Esophageal Pressure Measurements, in Patients With Acute Lung Injury |
Estimated Enrollment: | 200 |
Study Start Date: | May 2004 |
Estimated Study Completion Date: | May 2010 |
Arms | Assigned Interventions |
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EP: Experimental
Ventilation directed by esophageal balloon measurements to maintain a positive trans-pulmonary pressure at end expiration
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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.
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Control: Active Comparator
Ventilation based on the ARDSnet low tidal volume study
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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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with ALI/ARDS according to the International Consensus Conference criteria:
Exclusion Criteria:
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 |
Principal Investigator: | Daniel S Talmor, MD, MPH | Beth Israel Deaconess Medical Center |
Study ID Numbers: | 2004-P-000011/1; BIDMC, RO1 HL 52586 |
Study First Received: | August 4, 2005 |
Last Updated: | November 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00127491 History of Changes |
Health Authority: | United States: Institutional Review Board |
Acute Lung Injury Acute Respiratory Distress Syndrome Mechanical Ventilation Esophageal Pressures Randomized Controlled Trial |
Respiratory Tract Diseases Esophageal Disorder Lung Diseases Respiration Disorders |
Respiratory Distress Syndrome, Adult Acute Respiratory Distress Syndrome Esophageal Diseases |
Pathologic Processes Disease Respiratory Tract Diseases Lung Diseases |
Syndrome Respiration Disorders Respiratory Distress Syndrome, Adult |