Acute Lung Injury, Acute Respiratory Distress Syndrome
Conditions
Keywords
Acute Lung Injury, Acute Respiratory Distress Syndrome, Mechanical Ventilation, Esophageal Pressures, Randomized Controlled Trial
Brief summary
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).
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.
Interventions
PROCEDUREPlacement 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.
Low tidal volume ventilation strategy (ARDSnet)
OTHERTranspulmonary pressure-directed ventilation (EPVent)
Transpulmonary pressure-directed ventilation using measurements from the esophageal balloon.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oxygenation as measured by the PO2/FiO2 (P/F) ratio | 72 hours from enrollment |
Secondary
| Measure | Time frame |
|---|---|
| Ventilator free days | At 28 days |
| Markers of inflammation | In first 72 hours |
| Mortality | At 28, 90 and 180 days |
| Length of stay | Hospital and ICU |
Countries
United States
Outcome results
None listed