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ISRCTN
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ISRCTN07448447
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ClinicalTrials.gov identifier
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Public title
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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)
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Scientific title
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Acronym
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3CPO
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Serial number at source
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HTA 01/43/01
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Study hypothesis
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To assess the clinical effectiveness of non-invasive ventilation against standard therapy alone
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Ethics approval
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Not requested at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cardiovascular diseases: Heart disease
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Participants - inclusion criteria
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1. More than 16 years
2. Acute Cardiogenic Pulmonary Oedema (ACPO) principal clinical complaint
3. Confirmed diagnosis of ACPO
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Participants - exclusion criteria
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1. Patients needing immediate life-saving interventions
2. Inability to provide informed consent
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Anticipated start date
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01/06/2003
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Anticipated end date
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30/04/2008
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Status of trial
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Completed
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Patient information material
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Target number of participants
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1200 (this information was added on the 12th June 2007)
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Interventions
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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.
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Primary outcome measure(s)
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Added on the 12th June 2007:
1. NIV versus standard therapy: seven-day mortality
2. CPAP versus NIPPV: seven-day mortality or intubation
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Secondary outcome measure(s)
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Added on the 12th June 2007:
1. Physiology
2. Side-effects including Myocardial Infacrtion (MI)
3. Cost-effectiveness
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/18614781
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Contact name
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Dr
Alasdair James
Gray
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Address
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Emergency Department
Royal Infirmary of Edinburgh
51 Little France Crescent
Old Dalkeith Road
School of Health and Related Research
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City/town
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Edinburgh
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Zip/Postcode
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EH16 4SA
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Country
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United Kingdom
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Tel
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+44 (0)131 242 1334
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Fax
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+44 (0)131242 1339
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Email
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alasdair.gray@luht.scot.nhs.uk
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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25/04/2003
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Last edited
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11/07/2008
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Date ISRCTN assigned
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25/04/2003
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