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ISRCTN
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ISRCTN00203325
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ClinicalTrials.gov identifier
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Public title
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Ultrasound guided jugular vein cannulation
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Scientific title
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Internal jugular vein cannulation using ultrasound guidance: a prospective randomised controlled trial
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Real time ultrasound guided cannulation of the internal jugular vein (IJV) is more efficient than catheterisation using ultrasound located landmarks.
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Ethics approval
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Ethics approval received from "Attikon" Hospital Ethics Committee on the 23rd January 2004 (ref: AP. 420/CP "ATTIKON" Hospital).
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Study design
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Prospective randomised controlled trial
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Countries of recruitment
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Greece
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Disease/condition/study domain
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Jugular vein cannulation
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Participants - inclusion criteria
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1. Patients of the "Attikon" Hospital, in General Surgery, Oncology and Haematology Departments
2. Males and females, from 18 - 80 years of age
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Participants - exclusion criteria
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Patients with internal jugular vein thrombosis.
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Anticipated start date
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01/02/2004
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Anticipated end date
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30/05/2008
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Status of trial
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Ongoing
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Patient information material
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Target number of participants
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212 - 556
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Interventions
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Patients who need an internal jugular vein catheter are randomised, using sealed envelopes, in two groups:
Group A (real time ultrasound [U/S]): IJV Cannulation using real time ultrasound
Group B (U/S located landmarks): IJV cannulation using ultrasound located landmarks
Patients with IJV thrombosis were excluded. The success rate of cannulation was measured (attempts less than or equal to three by the same operator), along with the duration of time until successful cannulation and complications.
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Primary outcome measure(s)
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Success rate of cannulation, attempts less than or equal to three by the same operator.
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Secondary outcome measure(s)
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1. Number of tries
2. Time to complete cannulation
3. Immediate complications (assessed by the operator and his assistance)
4. Place of the catheter using x-ray just after cannulation (assessed by a radiologist)
5. Early complications, measured at days 1, 2 and 5 post cannulation (assesed by a senior surgeon)
6. Later complications (late infections and obstruction of catheters’ "life" up to six months, assesed by a physician and/or a senior nurse)
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Sources of funding
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"Attikon" Teaching Hospital (Greece) - University of Athens
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Trial website
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Publications
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Contact name
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Prof
Theodore
Liakakos
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Address
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"Attikon" Hospital
3rd Academic Department of Surgery
Haidari
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City/town
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Athens
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Zip/Postcode
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124 10
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Country
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Greece
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Email
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theodlia@otenet.gr
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Sponsor
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"Attikon" Teaching Hospital (Greece) - University of Athens
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Address
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1 Rimini Str
Haidari
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City/town
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Athens
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Zip/Postcode
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124 10
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Country
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Greece
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Email
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gchklin@med.uoa.gr
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Date applied
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19/03/2008
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Last edited
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08/04/2008
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Date ISRCTN assigned
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08/04/2008
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