Mechanical Ventilation, Directed by Esophageal Pressure Measurements, in Patients With Acute Lung Injury - Full Text View

Sponsors and Collaborators:	Beth Israel Deaconess Medical Center National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT00127491

Purpose

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
Acute Lung Injury Acute Respiratory Distress Syndrome	Procedure: Placement of an esophageal balloon measurements	Phase II Phase III

MedlinePlus related topics: Esophagus Disorders

Drug Information available for: BaseLine

U.S. FDA Resources

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

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:

Oxygenation as measured by the PO2/FiO2 (P/F) ratio [ Time Frame: 72 hours from enrollment ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	200
Study Start Date:	May 2004
Estimated Study Completion Date:	May 2010

Arms	Assigned Interventions
EP: Experimental Ventilation directed by esophageal balloon measurements to maintain a positive trans-pulmonary pressure at end expiration	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.
Control: Active Comparator Ventilation based on the ARDSnet low tidal volume study	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.

Arms

Assigned Interventions

EP: Experimental

Ventilation directed by esophageal balloon measurements to maintain a positive trans-pulmonary pressure at end expiration

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.

Control: Active Comparator

Ventilation based on the ARDSnet low tidal volume study

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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00127491

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:

Daniel S Talmor, MD, MPH

Beth Israel Deaconess Medical Center

More Information

Publications indexed to this study:

Talmor D, Sarge T, Malhotra A, O'Donnell CR, Ritz R, Lisbon A, Novack V, Loring SH. Mechanical ventilation guided by esophageal pressure in acute lung injury. N Engl J Med. 2008 Nov 13;359(20):2095-104. Epub 2008 Nov 11.

Talmor D, Sarge T, Legedza A, O'Donnell CR, Ritz R, Loring SH, Malhotra A. Cytokine release following recruitment maneuvers. Chest. 2007 Nov;132(5):1434-9. Epub 2007 Oct 9.

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
Health Authority:	United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:

Acute Lung Injury
Acute Respiratory Distress Syndrome
Mechanical Ventilation
Esophageal Pressures
Randomized Controlled Trial

Study placed in the following topic categories:

Esophageal disorder
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders

Respiratory Distress Syndrome, Adult
Acute respiratory distress syndrome
Esophageal Diseases

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 16, 2009