| Efficacy and economic assessment of conventional ventilatory support versus extracorporeal membrane oxygenation for severe adult respiratory failure (CESAR): a multicentre randomised controlled trial. | |
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MedLine Citation:
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PMID: 19762075 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Severe acute respiratory failure in adults causes high mortality despite improvements in ventilation techniques and other treatments (eg, steroids, prone positioning, bronchoscopy, and inhaled nitric oxide). We aimed to delineate the safety, clinical efficacy, and cost-effectiveness of extracorporeal membrane oxygenation (ECMO) compared with conventional ventilation support. METHODS: In this UK-based multicentre trial, we used an independent central randomisation service to randomly assign 180 adults in a 1:1 ratio to receive continued conventional management or referral to consideration for treatment by ECMO. Eligible patients were aged 18-65 years and had severe (Murray score >3.0 or pH <7.20) but potentially reversible respiratory failure. Exclusion criteria were: high pressure (>30 cm H(2)O of peak inspiratory pressure) or high FiO(2) (>0.8) ventilation for more than 7 days; intracranial bleeding; any other contraindication to limited heparinisation; or any contraindication to continuation of active treatment. The primary outcome was death or severe disability at 6 months after randomisation or before discharge from hospital. Primary analysis was by intention to treat. Only researchers who did the 6-month follow-up were masked to treatment assignment. Data about resource use and economic outcomes (quality-adjusted life-years) were collected. Studies of the key cost generating events were undertaken, and we did analyses of cost-utility at 6 months after randomisation and modelled lifetime cost-utility. This study is registered, number ISRCTN47279827. FINDINGS: 766 patients were screened; 180 were enrolled and randomly allocated to consideration for treatment by ECMO (n=90 patients) or to receive conventional management (n=90). 68 (75%) patients actually received ECMO; 63% (57/90) of patients allocated to consideration for treatment by ECMO survived to 6 months without disability compared with 47% (41/87) of those allocated to conventional management (relative risk 0.69; 95% CI 0.05-0.97, p=0.03). Referral to consideration for treatment by ECMO led to a gain of 0.03 quality-adjusted life-years (QALYs) at 6-month follow-up [corrected]. A lifetime model predicted the cost per QALY of ECMO to be pound19 252 (95% CI 7622-59 200) at a discount rate of 3.5%. INTERPRETATION: We recommend transferring of adult patients with severe but potentially reversible respiratory failure, whose Murray score exceeds 3.0 or who have a pH of less than 7.20 on optimum conventional management, to a centre with an ECMO-based management protocol to significantly improve survival without severe disability. This strategy is also likely to be cost effective in settings with similar services to those in the UK. FUNDING: UK NHS Health Technology Assessment, English National Specialist Commissioning Advisory Group, Scottish Department of Health, and Welsh Department of Health. |
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Authors:
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Giles J Peek; Miranda Mugford; Ravindranath Tiruvoipati; Andrew Wilson; Elizabeth Allen; Mariamma M Thalanany; Clare L Hibbert; Ann Truesdale; Felicity Clemens; Nicola Cooper; Richard K Firmin; Diana Elbourne; |
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Publication Detail:
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Type: Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2009-09-15 |
Journal Detail:
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Title: Lancet Volume: 374 ISSN: 1474-547X ISO Abbreviation: Lancet Publication Date: 2009 Oct |
Date Detail:
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Created Date: 2009-10-19 Completed Date: 2009-12-02 Revised Date: 2010-12-13 |
Medline Journal Info:
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Nlm Unique ID: 2985213R Medline TA: Lancet Country: England |
Other Details:
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Languages: eng Pagination: 1351-63 Citation Subset: AIM; IM |
Affiliation:
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Department of Cardiothoracic Surgery, Glenfield Hospital, Leicester, UK. giles.peek@uhl-tr.nhs.uk |
| Data Bank Information | |
Bank Name/Acc. No.:
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ISRCTN/ISRCTN47279827 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Adult Aged Cost-Benefit Analysis Extracorporeal Membrane Oxygenation* / economics Female Humans Male Middle Aged Respiration, Artificial* / economics Respiratory Insufficiency / therapy* Treatment Outcome Young Adult |
| Grant Support | |
ID/Acronym/Agency:
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//Department of Health |
| Investigator | |
Investigator/Affiliation:
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R Adfield / ; E Allen / ; F Clemens / ; E Coates / ; N Cooper / ; K Diallo / ; D Edbrooke / ; D Elbourne / ; G Faulkner / ; J Fawcett / ; D Field / ; R Firmin / ; D Goldhill / ; B Gutteride / ; P Hardy / ; S Harris / ; C Hibbert / ; S Holden / ; N Jones / ; H Killer / ; M Mugford / ; W Nganasurian / ; G Peek / ; M Pepperman / ; D Piercy / ; S Robertson / ; J Scott / ; A Tattersfield / ; M Thalanany / ; R Tiruvoipati / ; K Tomlin / ; A Truesdale / ; N Webster / ; A Wilson / ; E Allen / ; F Clemens / ; N Cooper / ; K Diallo / ; Y Doyle / ; D Edbrooke / ; D Elbourne / ; G Faulkner / ; R Firmin / ; D Francis / ; P Hardy / ; S Harris / ; C Harvey / ; C Hibbert / ; N Jones / ; H Killer / ; M Mugford / ; G Peek / ; D Piercy / ; S Robertson / ; M Thalanany / ; R Tiruvoipati / ; K Tomlin / ; A Truesdale / ; A Wilson / ; E Allen / ; F Clemens / ; K Diallo / ; D Elbourne / ; P Hardy / ; D Piercy / ; S Robertson / ; K Tomlin / ; A Truesdale / ; M Aslam / ; G Faulkner / ; R Firmin / ; S Harris / ; C Harvey / ; H Killer / ; N Jones / ; C McCulloch / ; G Peek / ; J Redfern / ; R Reeves / ; N Roberts / ; L Russell / ; A Sheward / ; L Smith / ; A Sosnowski / ; A Tebbat / ; R Tiruvoipati / ; D Altman / ; R Doll / ; T Evans / ; D Macrae / ; J Sanderson-Mann / ; P Sinfield / ; C Tarrant / ; H Watkinson / ; A Wilson / ; A King / ; M Bennett / ; G McPherson / ; A Walker / ; C Waldmann / ; D Goldhill / ; J Scriven / ; K Price / ; T Leach / ; D Bagnall / ; L Clements / ; J P Gannon / ; J Chambers / ; P Grice / ; C Taylor / ; I Taylor / ; M Dunlop / ; D Kerr / ; R Harris / ; W Lee / ; P Wootton / ; D Niblett / ; F Barchard / ; F Bertasius / ; S Gower / ; J Dickson / ; K Roberts / ; W Doherty / ; A Culpepper / ; S Maisey / ; R P Wroth / ; L Barton / ; D Handley / ; M Calleja / ; J Baldwin / ; P Harris / ; K Greatorex / ; J Herring / ; L Thomas / ; B Bray / ; B Keeling / ; L Shaikh / ; J Thomas / ; B Tehan / ; L Burgoyne / ; K Owen / ; R Firmin / ; G Peek / ; D Turner / ; L Marriot / ; J Morton / ; L Randall / ; C Roberts / ; A Bailey / ; E Maggs / ; J Hutchinson / ; L Davies / ; L Kehoe / ; J O'Riordan / ; S Ainley / ; S Maguire / ; I Smith / ; D Muir / ; N Smith / ; P Sigston / ; A Collins / ; L Twohey / ; C Harland / ; J Thomas / ; M Ross / ; M Platt / ; A Tinsley / ; P Spiers / ; J Cadwallader / ; D Turner / ; K Coulson / ; A Martin / ; T Schiavone / ; M Smith / ; A Turley / ; C Taylor / ; S Bennett / ; R Kyte / ; M Patten / ; M Kermack / ; J Hunter / ; H Cooper / ; J Rhodes / ; R Slater / ; W Cook / ; P Chambers / ; J McHugh / ; S Holbeck / ; C McMullen / ; L Woodbridge / ; J R Colvin / ; B Soutar / ; M Longshaw / ; E Jones / ; S Michael / ; J Sutherland / ; L Wadsworth / ; M Levitt / ; C Crocker / ; M Hope / ; M Spittal / ; D Connolly / ; I Hamilton / ; B Jenkins / ; J Davies / ; M Esmail / ; L Evans / ; F McAuley / ; E Britton-Smith / ; A Jackson / ; V McLean / ; C A Lee / ; G Calder / ; D Harling / ; D O'Malley / ; H Proctor / ; R Saad / ; J Hilton / ; M Taylor / ; W Price / ; S Westwell / ; D Edbrooke / ; K Bailey / ; S Smith / ; G Masterson / ; T Rowan / ; P Duncan / ; C Richarson / ; J M Bellin / ; A Markham / ; M Willis / ; T Samuel / ; R Sharawi / ; A Holmes / ; S Snelson / ; D Higgins / ; J Lee / ; P Tyler / ; D Jayson / ; G Levens / ; H Rymell / ; M Smith / ; M Vangikar / ; J Webb / ; C Wareham / ; J Bean / ; A Read / ; J Hawkins / ; J Lewis / ; N Worral / ; J Rigg / ; K Berry / ; S Swire / ; J Everatt / ; G Walker / ; K Marchant / ; M Garfield / ; C Calder / ; M Parfitt / ; D Kennedy / ; S Nourse / ; I O'Connor / ; E Shearer / ; P Hale / ; S Tabener / ; V Gupta / ; L Morgan / ; B Carr / ; T Proctor / ; A Normington / ; G Findlay / ; M Smithie / ; E Hutcheon / ; D Kelly / ; M Drummond / ; J Little / ; D Watson / ; T Mason / ; G McMillan / ; J Little / ; T Mason / ; G McMillan / ; J Aulakh / ; H Reading / ; V Page / ; T Stambach / ; C Armstrong / ; W Dore / ; J Cardy / ; P Oats / ; S Humphreys / ; N Volpe / ; W C Edmondson / ; K Miller / ; T Dexter / ; R Bryson / ; G Toovey / ; A Chan / ; R Lo / ; G L Dabuco / ; N Mathew / ; M Garrioch / ; P Ritchie / ; F Bage / ; L Williams / ; J Tint / |
| Comments/Corrections | |
Comment In:
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Lancet. 2010 Feb 13;375(9714):549-50; author reply 551
[PMID:
20159280
]
Crit Care. 2010;14(2):308 [PMID: 20447318 ] Lancet. 2010 Feb 13;375(9714):549; author reply 551 [PMID: 20159281 ] Lancet. 2010 Feb 13;375(9714):550-1; author reply 551 [PMID: 20159283 ] Lancet. 2009 Oct 17;374(9698):1307-8 [PMID: 19762074 ] Can J Anaesth. 2010 Mar;57(3):273-5 [PMID: 20077170 ] Lancet. 2010 Feb 13;375(9714):549; author reply 551 [PMID: 20159282 ] J R Coll Physicians Edinb. 2010 Jun;40(2):126-7 [PMID: 21125055 ] |
Erratum In:
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Lancet. 2009 Oct 17;374(9698):1330 |
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