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ISRCTN
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ISRCTN61258470
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ClinicalTrials.gov identifier
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Public title
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Ultrasound Cannulation of the Internal Jugular Vein
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Scientific title
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Ultrasound Cannulation of the Internal Jugular Vein: a prospective randomised controlled study
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Acronym
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N/A
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Serial number at source
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Ultrasound/022006
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Study hypothesis
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This study was designed to evaluate whether real-time ultrasound-guided cannulation of the internal jugular vein is superior to the standard landmark method.
As of 08/11/2010 this record was updated to include an addition to the inclusion criteria as a result of a protocol change in January 2006. This is as follows:
"Ultrasound guided cannulation of the internal jugular vein versus the landmark method was extended at the subclavian vein site as from 2006 until 2010 in the same critical care population following the same methodology and the same protocol. Currently, 200 additional patients were enlisted for the ultrasound group and 201 additional patients were enlisted for the landmark group concerning the cannulation of the subclavian vein."
Thus, the inclusion criteria have been updated, and the target number of participants has been increased from 900 to 1301.
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Lay summary
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Ethics approval
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The study was in conformation with the principles outlined in the Declaration of Helsinki and was approved by the Institutional Ethics Committee in 1999 (ref: 1999/02/ICUGG)
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Study design
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Prospective, randomised controlled study
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Countries of recruitment
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Greece
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Disease/condition/study domain
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Critically ill patients
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Participants - inclusion criteria
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Amended as of 08/11/2010:
Critical care patients which are hospitalised in the intensive care unit from January 2000 to December 2006 and were all mechanically ventilated requiring central/subclavian venous access for various therapeutic reasons.
Initial information at time of registration:
Critical care patients which are hospitalised in the intensive care unit from January 2000 to December 2006 and were all mechanically ventilated requiring central venous access for various therapeutic reasons.
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Participants - exclusion criteria
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Patients who were not on mechanical ventilation
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Anticipated start date
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01/01/2000
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Anticipated end date
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01/12/2006
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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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1301 (added as of 08/11/2010; previously was 900)
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Interventions
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Ultrasound-guided cannulation of the internal jugular vein versus the standard landmark method
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Primary outcome measure(s)
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Cannulation of the internal jugular vein was achieved in all patients using ultrasound and in 425 of the patients (94.4%), the landmark technique (p <0.001) was used. Average access time (skin to vein) and the number of attempts were significantly reduced in the ultrasound group of patients compared to the landmark group (p<0.001). In the landmark group, puncture of the carotid artery occurred in 10.6% of patients, hematoma in 8.4%, hemothorax in 1.7%, pneumothorax in 2.4% and central venous catheter-associated blood stream infections in 16% which were all significantly increased compared to the ultrasound group (p<0.001).
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Secondary outcome measure(s)
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There were no significant differences in gender, age, body mass index, left or right side of cannulation and in the presence of risk factors for difficult venous cannulation such as prior catheterization, limited sites for access attempts, previous difficulties during catheterization, previous mechanical complication, known vascular abnormality, untreated coagulopathy, skeletal deformity and cannulation during cardiac arrest between the two groups of patients. Furthermore, the physicians who performed the procedures had comparable experience in the placement of central venous catheters (p = non-significant).
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Sources of funding
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General State Hospital of Athens (Greece) - Intensive Care Unit
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Trial website
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Publications
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1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17112371
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21494105
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Contact name
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Dr
Dimitrios
Karakitsos
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Address
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Intensive Care Unit
General State Hospital of Athens
154 Mesogeion Avenue
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City/town
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Athens
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Zip/Postcode
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11527
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Country
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Greece
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Tel
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+30 (0)694 7127965
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Fax
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+30 (0)210 7480188
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Email
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karakd@edu.med.uoc.gr
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Sponsor
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General State Hospital of Athens (Greece)
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Address
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Intensive Care Unit
154 Mesogeion Avenue
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City/town
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Athens
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Zip/Postcode
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11527
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Country
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Greece
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Tel
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+30 (0)210 7480188
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Fax
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+30 (0)210 7480188
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Email
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icugg@otenet.gr
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Date applied
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10/04/2006
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Last edited
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21/04/2011
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Date ISRCTN assigned
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23/05/2006
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