Background The aim of this study was to measure health utility and survival in patients with acute cardiogenic pulmonary oedema (ACPO), identify predictors of outcome and determine the effect of initial treatment with non-invasive ventilation (NIV) upon outcomes.
Methods A randomised controlled trial was conducted at 26 hospitals in the UK. 1069 adults with ACPO were randomised to continuous positive airway pressure (CPAP), non-invasive positive pressure ventilation (NIPPV) or standard oxygen therapy. The main outcome measures were survival to 1–5 years, health utility measured using the EQ-5D survey at 1, 3 and 6 months, and quality-adjusted life years (QALYs).
Results Median survival was 771 days (95% CI 669 to 875), with no difference between the three treatment groups (p=0.827). Age (HR 1.042, 95% CI 1.031 to 1.052), chronic obstructive pulmonary disease (HR 1.13, 95% CI 1.06 to 1.62), cerebrovascular disease (HR 1.41, 95% CI 1.14 to 1.73) and diabetes mellitus (HR 1.31, 95% CI 1.01 to 1.63) independently predicted mortality. Mean EQ-5D scores were 0.578, 0.576 and 0.582 at 1, 3 and 6 months, respectively, with no significant difference between the treatment groups. Male gender (+0.045 QALYs, 95% CI 0.009 to 0.081) and cerebrovascular disease (−0.080 QALYs, 95% CI −0.131 to −0.029) independently predicted health utility.
Conclusion Patients with ACPO have high mortality and reduced health utility. Initial treatment with CPAP or NIPPV does not alter subsequent survival or health utility.
- Heart failure
- quality of life
- randomised controlled trial
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The 3CPO research team Alasdair Gray (Chief Investigator), Professor and Consultant in Emergency Medicine, Royal Infirmary of Edinburgh; David Newby, Professor of Cardiology and Consultant Cardiologist, Royal Infirmary of Edinburgh; Steve Goodacre, Professor of Emergency Medicine, University of Sheffield; Jon Nicholl, Professor, Health Service Research, University of Sheffield; Catherine Kelly, Consultant Physician in Acute Medicine, Royal Infirmary of Edinburgh; Steven Crane, Consultant in Emergency Medicine, York Hospital; Mark Elliott, Consultant Respiratory & General Physician, St James University Hospital, Leeds; Neil Douglas, Professor of Sleep Medicine, Royal Infirmary of Edinburgh; Taj Hassan, Consultant in Emergency Medicine, Leeds General Infirmary; Paul Plant, Consultant in Respiratory Medicine, St James University Hospital, Leeds; Fiona Sampson, Research Fellow, University of Sheffield; Kathryn Paulucy, Clerical Officer, University of Sheffield; Moyra Masson, Trial Manager, Royal Infirmary of Edinburgh; Simon Dixon, Professor of Health Economics, University of Sheffield.
Funding This work was supported by the United Kingdom National Institute for Health Research Health Technology Assessment Programme (grant number 01/43/01). The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Department of Health.
Competing interests None.
Ethics approval This study was conducted with the approval of the Scotland A MREC.
Provenance and peer review Not commissioned; externally peer reviewed.