Mechanical Ventilation, Directed by Esophageal Pressure Measurements, in Patients With Acute Lung Injury
- Conditions
- Acute Lung InjuryAcute Respiratory Distress Syndrome
- Interventions
- Procedure: Placement of an esophageal balloon measurementsOther: Transpulmonary pressure-directed ventilation (EPVent)Other: Low tidal volume ventilation
- Registration Number
- NCT00127491
- Lead Sponsor
- Beth Israel Deaconess Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EPVent Transpulmonary pressure-directed ventilation (EPVent) All patients will have an esophageal balloon placed for the purpose of obtaining transpulmonary pressure measurements. The intervention group will undergo transpulmonary pressure-directed controlled mechanical ventilation using parameters directed by the initial balloon measurements. Driving pressures will be adjusted to maintain a transpulmonary plateau pressure of less then 30. The PEEP setting will be set to achieve a transpulmonary end expiratory pressure of 0. Repeat PES measurements will be done at 24, 48 and 72 hours following the initial measurements. Additional measurements will be taken as clinically indicated. Ventilator management by PES measurements will continue for a period of 72 hours. Control Low tidal volume ventilation All patients will have an esophageal balloon placed for the purpose of obtaining transpulmonary pressure measurements. The control group will be managed using the low tidal volume strategy laid out by the NIHBLI ARDSnet study. These recommendations include a set tidal volume of 6 ml/ kg. Respiratory rate and PEEP are set to maintain adequate ventilation and oxygenation. These settings will be continued for a period of 72 hours. Control Placement of an esophageal balloon measurements All patients will have an esophageal balloon placed for the purpose of obtaining transpulmonary pressure measurements. The control group will be managed using the low tidal volume strategy laid out by the NIHBLI ARDSnet study. These recommendations include a set tidal volume of 6 ml/ kg. Respiratory rate and PEEP are set to maintain adequate ventilation and oxygenation. These settings will be continued for a period of 72 hours. EPVent Placement of an esophageal balloon measurements All patients will have an esophageal balloon placed for the purpose of obtaining transpulmonary pressure measurements. The intervention group will undergo transpulmonary pressure-directed controlled mechanical ventilation using parameters directed by the initial balloon measurements. Driving pressures will be adjusted to maintain a transpulmonary plateau pressure of less then 30. The PEEP setting will be set to achieve a transpulmonary end expiratory pressure of 0. Repeat PES measurements will be done at 24, 48 and 72 hours following the initial measurements. Additional measurements will be taken as clinically indicated. Ventilator management by PES measurements will continue for a period of 72 hours.
- Primary Outcome Measures
Name Time Method Oxygenation as measured by the PO2/FiO2 (P/F) ratio 72 hours from enrollment
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States