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
|
Purpose
| 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
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
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 INR> 2 )
- Post transplant patients
Location and Contact Information
Stephen H Loring, MD 617-667-3092 sloring@caregroup.harvard.edu
Massachusetts
Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States; Recruiting
Stephen H Loring, MD 617-667-3092 sloring@caregroup.harvard.edu
Daniel S Talmor, MD, MPH, Principal Investigator, Beth Israel Deaconess Medical Center
More Information
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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