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Open Access Highly Accessed Study protocol

CESAR: conventional ventilatory support vs extracorporeal membrane oxygenation for severe adult respiratory failure

Giles J Peek1*, Felicity Clemens2, Diana Elbourne2, Richard Firmin1, Pollyanna Hardy23, Clare Hibbert5, Hilliary Killer1, Miranda Mugford4, Mariamma Thalanany4, Ravin Tiruvoipati1, Ann Truesdale2 and Andrew Wilson6

Author Affiliations

1 Department of Cardiothoracic Surgery, Glenfield Hospital, Groby Road, Leicester, LE3 9QP, UK

2 Medical Statistics Unit, London School of Hygiene and Tropical Medicine, Keppel St, London WC1E 7HT, UK

3 Clinical Epidemiology and Biostatistics Unit, Royal Children's Hospital, Melbourne, Australia

4 School of Medicine Health Policy and Practice, University of East Anglia, Norwich, NR4 7TJ, UK

5 School of Health and Related Research, University of Sheffield and RTI Health Solutions, Williams House Manchester Science Park, Manchester ME15 6SE, UK

6 Department of Health Sciences, University of Leicester, Leicester General Hospital, Leicester, LE5 4PW, UK

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BMC Health Services Research 2006, 6:163  doi:10.1186/1472-6963-6-163

Published: 23 December 2006

Abstract

Background

An estimated 350 adults develop severe, but potentially reversible respiratory failure in the UK annually. Current management uses intermittent positive pressure ventilation, but barotrauma, volutrauma and oxygen toxicity can prevent lung recovery. An alternative treatment, extracorporeal membrane oxygenation, uses cardio-pulmonary bypass technology to temporarily provide gas exchange, allowing ventilator settings to be reduced. While extracorporeal membrane oxygenation is proven to result in improved outcome when compared to conventional ventilation in neonates with severe respiratory failure, there is currently no good evidence from randomised controlled trials to compare these managements for important clinical outcomes in adults, although evidence from case series is promising.

Methods/Design

The aim of the randomised controlled trial of Conventional ventilatory support vs extracorporeal membrane oxygenation for severe adult respiratory failure (CESAR) is to assess whether, for patients with severe, but potentially reversible, respiratory failure, extracorporeal membrane oxygenation will increase the rate of survival without severe disability ('confined to bed' and 'unable to wash or dress') by six months post-randomisation, and be cost effective from the viewpoints of the NHS and society, compared to conventional ventilatory support. Following assent from a relative, adults (18–65 years) with severe, but potentially reversible, respiratory failure (Murray score ≥ 3.0 or hypercapnea with pH < 7.2) will be randomised for consideration of extracorporeal membrane oxygenation at Glenfield Hospital, Leicester or continuing conventional care in a centre providing a high standard of conventional treatment. The central randomisation service will minimise by type of conventional treatment centre, age, duration of high pressure ventilation, hypoxia/hypercapnea, diagnosis and number of organs failed, to ensure balance in key prognostic variables. Extracorporeal membrane oxygenation will not be available for patients meeting entry criteria outside the trial. 180 patients will be recruited to have 80% power to be able to detect a one third reduction in the primary outcome from 65% at 5% level of statistical significance (2-sided test). Secondary outcomes include patient morbidity and health status at 6 months.

Discussion

Analysis will be based on intention to treat. A concurrent economic evaluation will also be performed to compare the costs and outcomes of both treatments.