Mechanical Ventilation, Directed by Esophageal Pressure Measurements, in Patients With Acute Lung Injury
Recruitment status was Active, not recruiting
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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 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A RCT of Mechanical Ventilation, Directed by Esophageal Pressure Measurements, in Patients With Acute Lung Injury |
- Oxygenation as measured by the PO2/FiO2 (P/F) ratio [ Time Frame: 72 hours from enrollment ]
- 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 |
|---|---|
|
Experimental: EP
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.
|
|
Active Comparator: Control
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 |
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| 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 |
More Information
No publications provided by Beth Israel Deaconess Medical Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00127491 History of Changes |
| Other Study ID Numbers: | 2004-P-000011/1; BIDMC, RO1 HL 52586 |
| Study First Received: | August 4, 2005 |
| Last Updated: | November 2, 2007 |
| 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 |
Additional relevant MeSH terms:
|
Esophageal Diseases Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Lung Injury Gastrointestinal Diseases Digestive System Diseases |
Lung Diseases Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Thoracic Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on May 23, 2013