Randomised controlled trial and parallel economic evaluation of conventional ventilatory support versus extracorporeal membrane oxygenation for severe adult respiratory failure (CESAR)

Objectives: To determine the comparative effectiveness and cost-effectiveness of conventional ventilatory support versus extracorporeal membrane oxygenation (ECMO) for severe adult respiratory failure. Design: A multicentre, randomised controlled trial with two arms. Setting: The ECM centre at Glenfield Hospital, Leicester, and approved conventional treatment centres and referring hospitals throughout the UK. Participants: Patients aged 18-65 years with severe, but potentially reversible, respiratory failure, defined as a Murray lung injury score >= 3.0, or uncompensated hypercapnoea with a pH <7.20 despite optimal conventional treatment. Interventions: Participants were randomised to conventional management (CM) or to consideration of ECMO. Main outcome measures: The primary outcome measure was death or severe disability at 6 months. Secondary outcomes included a range of hospital indices: duration of ventilation, use of high frequency/oscillation/jet ventilation, use of nitric oxide, prone positioning, use of steroids, length of intensive care unit stay, and length of hospital stay and (for ECMO patients only) mode (venovenous/veno-arterial), duration of ECMO, blood flow and sweep flow. Results: A total of 180 patients (90 in each arm) were randomised from 68 centres. Three patients in 10.75 for the ECM group compared with 7.31 for the conventional group. Costs to patients and their relatives, including out of pocket and time costs, were higher for patients allocated to ECMO. Conclusions: Compared with CM, transferring adult patients with severe but potentially reversible respiratory failure to a single centre specialising in the treatment of severe respiratory failure for consideration of ECM significantly increased survival without severe disability. Use of ECM in this way is likely to be costeffective when compared with other technologies currently competing for health resources.