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The effect of continuous positive airway pressure (CPAP) and non-invasive positive pressure ventilation (NIPPV) in acute cardiogenic pulmonary oedema (ACPO)
ISRCTN ISRCTN07448447
DOI 10.1186/ISRCTN07448447
ClinicalTrials.gov identifier
EudraCT number
Public title The effect of continuous positive airway pressure (CPAP) and non-invasive positive pressure ventilation (NIPPV) in acute cardiogenic pulmonary oedema (ACPO)
Scientific title
Acronym 3CPO
Serial number at source HTA 01/43/01
Study hypothesis To assess the clinical effectiveness of non-invasive ventilation against standard therapy alone

More details can be found at http://www.hta.ac.uk/project/1338
Protocol can be found at http://www.hta.ac.uk/protocols/200100430001.pdf
Lay summary
Ethics approval Not requested at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Cardiovascular diseases: Heart disease
Participants - inclusion criteria 1. More than 16 years
2. Acute Cardiogenic Pulmonary Oedema (ACPO) principal clinical complaint
3. Confirmed diagnosis of ACPO
Participants - exclusion criteria 1. Patients needing immediate life-saving interventions
2. Inability to provide informed consent
Anticipated start date 01/06/2003
Anticipated end date 30/04/2008
Status of trial Completed
Patient information material
Target number of participants 1200 (this information was added on the 12th June 2007)
Interventions Continuous Positive Airway Pressure (CPAP) versus Non-Invasive Positive Pressure Ventilation (NIPPV)

Please note that, as of 28 January 2008, the anticipated end date of this trial was updated from 31 December 2007 to 30 April 2008.

Please note that as of 12th June 2007, the anticipated end date of this trial was extended to 31st December 2007 (Anticipated end date provided at time of registration: 30 June 2006). Recruitment to this trial was closed on 30 April 2007.
Primary outcome measure(s) Added on the 12th June 2007:
1. NIV versus standard therapy: seven-day mortality
2. CPAP versus NIPPV: seven-day mortality or intubation
Secondary outcome measure(s) Added on the 12th June 2007:
1. Physiology
2. Side-effects including Myocardial Infacrtion (MI)
3. Cost-effectiveness
Sources of funding NIHR Health Technology Assessment Programme - HTA (UK)
Trial website
Publications 1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18614781
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19615296
3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20511258
Contact name Dr  Alasdair James  Gray
  Address Emergency Department
Royal Infirmary of Edinburgh
51 Little France Crescent
Old Dalkeith Road
School of Health and Related Research
  City/town Edinburgh
  Zip/Postcode EH16 4SA
  Country United Kingdom
  Tel +44 (0)131 242 1334
  Fax +44 (0)131242 1339
  Email alasdair.gray@luht.scot.nhs.uk
Sponsor Department of Health (UK)
  Address Quarry House
Quarry Hill
  City/town Leeds
  Zip/Postcode LS2 7UE
  Country United Kingdom
  Tel +44 (0)1132 545 843
  Email Sheila.Greener@doh.gsi.gov.uk
  Sponsor website: http://www.dh.gov.uk/en/index.htm
Date applied 25/04/2003
Last edited 02/08/2010
Date ISRCTN assigned 25/04/2003
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