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ISRCTN
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ISRCTN85787933
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ClinicalTrials.gov identifier
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Public title
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Central line insertion project (CLIP)
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Scientific title
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Acronym
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CLIP
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Serial number at source
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HTA 95/16/06
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Study hypothesis
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A single centre randomised trial of central venous catheter insertion by a clinical nurse specialist, under image guidance or on the ward without routine access to image guidance. Approximately 400 patients will be randomised to compare safety, adverse events, efficacy, quality of life and cost. The study will identify the incremental cost effectiveness ratio for nurse insertion and develop and evaluate a training programme to generalise these benefits throughout the NHS. A model will be developed to analyse the long term benefits for patients and the NHS from generalised adoption of the optimal methods of insertion throughout the NHS.
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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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Not applicable
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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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01/01/1999
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Anticipated end date
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31/12/2000
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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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400
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Interventions
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1. Central venous catheter insertion by a clinical nurse specialist under image guidance
2. Central venous catheter insertion on the ward without routine access to image guidance
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Primary outcome measure(s)
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Catheter-tip misplacement and this was expected to be higher in the blind arm. When comparing the skill level of the trainer and the trainees, pneumothorax was the primary clinical outcome measure.
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Secondary outcome measure(s)
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Other outcomes measures included arterial puncture, haematoma, infection, failed insertion and assistance from other healthcare professionals.
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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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http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14611735
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Contact name
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Ms
Angela
Boland
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Address
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University of Liverpool
Ashton Street Medical School
Ashton Street
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City/town
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Liverpool
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Zip/Postcode
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L69 3GE
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Country
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United Kingdom
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Tel
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+44 (0)151 794 5541
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Email
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a.boland@liv.ac.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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17/01/2008
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Date ISRCTN assigned
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25/04/2003
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