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ISRCTN
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ISRCTN96523406
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ClinicalTrials.gov identifier
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Public title
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Use of chlorhexidine gluconate 0.2% oral rinse (CHX) to reduce the incidence of nosocomial lower respirarory tract infections in intubated ICU adult patients
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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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N0185116743
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Study hypothesis
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Does the use of chlorhexidine gluconate 0.2% mouthwash reduce the incidence of nosocomial lower respiratory tract infection in adult patients who are intubated and receiving mechanical ventilation?
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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: Lower respiratory tract infection
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Participants - inclusion criteria
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Not provided at time of registration
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/08/2002
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Anticipated end date
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31/03/2004
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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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We propose to administer 15 ml chlorhexidine gluconate or placebo to the buccal, pharangeal, gingival tongue, roof of mouth and tooth surfaces with a sponge swab twice daily to intubated patients who are predicted to require mechanical ventilation. Broncheoalveolar lavage specimen will be sent for culture every 48 h and the following clinical observations will be recorded daily - white cell count, sputum appearance, temperature and chest X-ray changes. The study ends once the patient is extubated but the observations will be recorded for a further 7 days.
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Primary outcome measure(s)
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Aims and objectives: To find out whether the use of chlorhexidine gluconate 0.2% mouthwash reduces the incidence of nosocomial pneumonia in adult patients who are intubated and receiving mechanical 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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Plymouth Hospitals NHS Trust
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Trial website
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Publications
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Contact name
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Ms
Jacqueline
Bailey
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Address
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ICU Department
Level 04
Derriford Hospital
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City/town
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Plymouth
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Zip/Postcode
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PL6 8DH
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Country
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United Kingdom
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Tel
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+44 01752 777111
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Fax
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+44
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Email
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Sponsor
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Record provided by the NHS Trusts Clinical Trials Register - 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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Fax
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+44 (0)20 7307 2623
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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.doh.gov.uk
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Date applied
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12/09/2003
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Last edited
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03/01/2006
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Date ISRCTN assigned
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12/09/2003
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