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The OSCAR trial is being run by the ICS research group, and is funded by the Department of Health through the Health Technology Assessment (HTA) programme. The study is a pragmatic trial exploring whether HFOV, when used as the primary mode of ventilatory support in ARDS can reduce the 30 day mortality associated with this syndrome.
Summary protocol:
Hypothesis: Patients with ARDS treated with HFOV will have a decreased mortality at 30 days compared with those treated with conventional ventilation.
Design: Multicentre, open, randomised controlled trial with 2 groups: group 1 HFOV v's group 2, conventional positive pressure ventilation.
Setting: 10 ITU's in UK (SOCC and N3CC are defined as one site for this trial)
Primary outcome: Mortality 30 days after randomisation
Eligibility: Age >16 and weight >35Kg Receiving mechanical ventilation via an endotracheal or tracheostomy tube Having ARDS - Hypoxaemia with a PaO2/FiO2 ratio less than or equal to 26.7 kPa with a PEEP of 5 cmH2O or more, persisting for at least 12 hours - Bilat infiltrates on a chest X-ray - One or more risk factors for ARDS Not predicted to be extubated by the following evening. Ventilated for LESS than 7 consecutive days at the point of randomisation. Clinician is uncertain as to the utility of HFOV in that patient
Many thanks in anticipation. The trial Website is www.oscar-trial.org