Many patients with Acute Respiratory Distress Syndrome or ARDS need breathing support that is provided by a machine called a ventilator or respirator. The purpose of this study is to find out if a new method of setting the ventilator for patients with severe ARDS is better than the standard, commonly used way of setting the ventilator.
The ARDSnet protocol is the current, standard of care for ARDS. Mechanical ventilation is managed using low tidal volumes, relatively high respiratory rates, with oxygenation managed according to PEEP and FIO2 relationships as defined in a table. This study compares the ARDSnet protocol with an open lung approach to mechanical ventilation. The open lung approach uses a technique to recruit collapsed lung areas and then uses the lowest PEEP level that prevents recollapse of recruited lung units. The best PEEP level is determined by a decremental PEEP trial involving a series of pressure measurements taken after the recruitment maneuver. Both the ARDSnet protocol and the open lung approach require low tidal volumes and plateau pressures. Evidence suggests that using a mechanical ventilation strategy of recruitment maneuvers (to open the collapsed lung) followed by high PEEP (to prevent collapse of the opened lung) with control of transpulmonary pressure through lower plateau pressures would maximize homogeneity within the lung and as such, minimize shearing forces in the lung parenchyma, thus improving ventilation and outcome in mechanically ventilated ARDS patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
224
OLA Group: Open lung approach protocol and recruitment maneuvers ARDSnet Group: ARDSnet protocol
Massachusetts General Hospital
Boston, Massachusetts, United States
60 day mortality
Time frame: 60 days
ICU mortality
Time frame: Duration of ICU stay
Hospital mortality
Time frame: Duration of hospital stay
28 day mortality
Time frame: 28 days
180 day mortality
Time frame: 180 days
365 day mortality
Time frame: 365 days
Ventilator free days
Time frame: Hospital stay
Length of ICU stay
Time frame: Duration of ICU stay
Development of extra-pulmonary organ failures
Time frame: Duration of hospital stay
Duration of hospitalization
Time frame: Duration of hospital stay
Incidence of barotrauma
Time frame: Duration of hospital stay
Systemic inflammatory mediator levels
Time frame: Duration of hospital stay
Lung function 6 months after discharge
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Time frame: 6 months
Lung function 12 months after discharge
Time frame: 12 months
Need for rescue therapy
Time frame: Duration of hospital stay
Ventilation associated pneumonia rate
Time frame: Duration of hospital stay