Abstract | BACKGROUND: 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.
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Authors | Giles J Peek, Felicity Clemens, Diana Elbourne, Richard Firmin, Pollyanna Hardy, Clare Hibbert, Hilliary Killer, Miranda Mugford, Mariamma Thalanany, Ravin Tiruvoipati, Ann Truesdale, Andrew Wilson |
Journal | BMC health services research
(BMC Health Serv Res)
Vol. 6
Pg. 163
(Dec 23 2006)
ISSN: 1472-6963 [Electronic] England |
PMID | 17187683
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Topics |
- Adolescent
- Adult
- Aged
- Cost-Benefit Analysis
- Extracorporeal Membrane Oxygenation
(economics)
- Female
- Humans
- Lung Injury
- Male
- Middle Aged
- Respiration, Artificial
(adverse effects, economics)
- Respiratory Distress Syndrome
(mortality, therapy)
- Survival Rate
- Technology Assessment, Biomedical
- Treatment Outcome
- United Kingdom
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