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ISRCTN
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ISRCTN55387780
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ClinicalTrials.gov identifier
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Public title
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A comparison of high rate, low tidal volume ventilation and conventional ventilation in the management of acute lung injury (ALI) and acute respiratory distress syndrome (ARDS)
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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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N0436125551
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Study hypothesis
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Primary aim of the study is to show that there is an increase in ventilator free days in first 28 days using high respiratory rate, low tidal volume ventilation technique compared to standard ventilation techniques.
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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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Acute respiratory distress
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Participants - inclusion criteria
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Patients intubated and receiving mechanical ventilation who have an acute decrease in ratio of partial pressure of arterial oxygen to fraction of inspired oxygen reaching the criteria for ALI and ARDS set by the American-European consensus conference committee
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Participants - exclusion criteria
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Does not match inclusion criteria
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Anticipated start date
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01/11/2002
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Anticipated end date
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01/11/2004
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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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Not provided at time of registration
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Interventions
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Randomised controlled trial. Random allocation to:
1. New Treatment - high respiratory rate, low tidal volume ventilation
2. Standard Treatment - conventional ventilation
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Primary outcome measure(s)
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1. Ventilator free days in first 28 days
2. Reduced production of IL-6, IL-8 IL-10 Neutrophil count and tumour necrosis factor (TNF) in response to ventilation
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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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Leeds Teaching Hospitals NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Dr
H
Buglass
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Address
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Anaesthetics Department
Chancellor Wing
St James's University Hospital
Beckett Street
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City/town
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Leeds
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Zip/Postcode
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LS9 7TF
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Country
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United Kingdom
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Tel
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+44 (0)113 243 3144
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Fax
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+44 (0)113 242 6496
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Email
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r&d@leedsth.nhs.uk
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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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06/10/2009
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Date ISRCTN assigned
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30/09/2004
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