Kacmarek 2007.

Trial name or title	ARDSnet Protocol vs Open Lung Approach in ARDS
Methods	Randomized controlled trial
Participants	Included: participants with ARDS in the first 48 hours after diagnosis, PaO2/FIO2 must be < 200 with standard ventilator setting, no lung recruitment manoeuvres or adjunct therapy, total time on mechanical ventilation < 96 hours at time of randomization. Excluded: age < 18 years or > 80 years, weight < 35 kg PBW, body mass index > 60, intubated secondary to acute exacerbation of a chronic pulmonary disease, acute brain injury (ICP > 18 mm Hg), immunosuppression 2° to chemotherapy or radiation therapy, severe cardiac disease, pregnancy, sickle cell disease, neuromuscular disease, more than two organ failures, barotrauma, persistent haemodynamic instability, penetrating chest trauma, enrolment in another interventional study.
Interventions	Control: PEEP/FIO2 combination with target ranges for oxygenation: PaO2 between 55 and 80 mm Hg; SpO2 between 88% and 95%. Intervention: uses a technique with recruitment manoeuvres and optimal PEEP (the optimal PEEP level is determined by a decremental PEEP trial involving a series of pressure measurements taken after the recruitment manoeuvre).
Outcomes	Mortality at day 60. Mortality in the intensive care unit (ICU), Mortality before hospital discharge. Mortality at day 28, Mortality at day 180. Mortality at day 365. Ventilator‐free days. Length of ICU stay. Development of extra‐pulmonary organ failures. Duration of hospitalization. Incidence of barotrauma. Systemic inflammatory mediator levels. Lung function 6 months after discharge. Lung function 12 months after discharge. Need for rescue therapy. Ventilation‐associated pneumonia rate.
Starting date	February 1, 2007.
Contact information	Robert Kacmarek, Massachussets General Hospital, Boston, Massachussets, United States.
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