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ISRCTN
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ISRCTN81164973
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ClinicalTrials.gov identifier
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Public title
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Randomised controlled trial of closed circuit Continuous Positive Airway Pressure (CPAP) and open circuit CPAP with a Boussignac valve for the treatment of acute pulmonary oedema.
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0013101032
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Study hypothesis
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This study will seek to determine whether the Boussignac valve system is as effective as conventional CPAP using a Drager CF800 circuit.
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Lay summary
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Ethics approval
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Not provided 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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Respiratory: Acute pulmonary oedema
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Participants - inclusion criteria
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Patients with acute pulmonary oedema attending Accident and Emergency (A&E). We intend to recruit 50 patients to allow for recruitment errors and drop outs etc.
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Participants - exclusion criteria
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Does not meet inclusion criteria
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Anticipated start date
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01/10/2001
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Anticipated end date
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31/12/2003
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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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50
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Interventions
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The patient will be randomised to one of two groups:
1. CPAP with the closed circuit Drager CF800 system
OR
2. CPAP with the open circuit Vygon Boussignac valve system
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Primary outcome measure(s)
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The main outcome measure will be the PaCO2 at 30 and 60 minutes. Other outcome measures will be PaO2 at 30 and 60 minutes, need for intubation, and tolerance of mask/circuit.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Guy's and St Thomas' NHS Trust (UK)
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Trial website
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Publications
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2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15953223
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Contact name
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Dr
Peter
Leman
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Address
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Acute Medicine
St Thomas' Hospital
Lambeth Palace Road
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City/town
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London
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Zip/Postcode
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SE1 7EH
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Country
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United Kingdom
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Sponsor
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Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
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Address
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The Department of Health,
Richmond House,
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2004
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Last edited
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10/07/2009
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Date ISRCTN assigned
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30/09/2004
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