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A RCT of Mechanical Ventilation, Directed by Esophageal Pressure Measurements, in Patients with Acute Lung Injury. - Article


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Severe Acute Respiratory Syndrome (SARS)

Sars; Sars/severe Acute Respiratory Syndrome; Severe Acute Respiratory Syndrome


Clinical Trial: A RCT of Mechanical Ventilation, Directed by Esophageal Pressure Measurements, in Patients with Acute Lung Injury.

This study is currently recruiting patients.
Verified by Beth Israel Deaconess Medical Center August 2005

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 us to choose the best method of mechanical ventilation in patients with acute lung injury.
Condition Intervention Phase
Acute Lung Injury
Acute Respiratory Distress Syndrome
 Procedure: Ventilation directed by esophageal balloon measurements
Phase III

MedlinePlus related topics:  Respiratory Diseases

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Further Study Details: 
Primary Outcomes: Oxygenation as measured by the PO2/FiO2 (P/F) ratio
Secondary Outcomes: Ventilator free days; Length of stay; Markers of inflammation; Mortality
Expected Total Enrollment:  200

Study start: May 2004

The current standard of practice for ventilating patients with 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 underinflation during mechanical ventilation, and current practice ignores the effects of chest wall compression of the lungs, which can cause underinflation. We 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 pressures 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) vs. therapy directed by ARDSnet protocol, the current standard of care.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

- Patients with ALI/ ARDS according to the international consensus conference criteria.

  1. PaO2 / FiO2 ratio< 300
  2. Acute onset
  3. Bilateral Infiltrates on chest radiography
  4. PAOP < 18 or, in patients without a pulmonary artery catheter, no other evidence of abnormal cardiac function

Exclusion Criteria:

  1. Patients with esophageal varices
  2. Patients with esophageal trauma
  3. Patients with recent esophageal surgery
  4. Patients with coagulopathy (Platelets < 80k or INR> 2 )
  5. Post transplant patients

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00127491

Daniel S Talmor, MD, MPH      617-754-3257    dtalmor@bidmc.harvard.edu
Stephen H Loring, MD      617-667-3092    sloring@caregroup.harvard.edu

Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States; Recruiting
Daniel S Talmor, MD MPH  617-754-3257    dtalmor@bidmc.harvard.edu 
Stephen H Loring, MD  617-667-3092    sloring@caregroup.harvard.edu 

Study chairs or principal investigators

Daniel S Talmor, MD, MPH,  Principal Investigator,  Beth Israel Deaconess Medical Center   

More Information

Study ID Numbers:  2004-P-000011/1; BIDMC
Last Updated:  August 5, 2005
Record first received:  August 4, 2005
ClinicalTrials.gov Identifier:  NCT00127491
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-23


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October 7, 2008



Page Updated: October 3, 2005
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