Contact information
Type
Scientific
Primary contact
Dr Dimitrios Karakitsos
ORCID ID
Contact details
Intensive Care Unit
General State Hospital of Athens
154 Mesogeion Avenue
Athens
11527
Greece
+30 (0)694 7127965
karakd@edu.med.uoc.gr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Ultrasound/022006
Study information
Scientific title
Ultrasound Cannulation of the Internal Jugular Vein: a prospective randomised controlled study
Acronym
Study hypothesis
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.
Ethics approval
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)
Study design
Prospective, randomised controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Critically ill patients
Intervention
Ultrasound-guided cannulation of the internal jugular vein versus the standard landmark method
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
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).
Secondary outcome measures
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).
Overall trial start date
01/01/2000
Overall trial end date
01/12/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1301 (added as of 08/11/2010; previously was 900)
Participant exclusion criteria
Patients who were not on mechanical ventilation
Recruitment start date
01/01/2000
Recruitment end date
01/12/2006
Locations
Countries of recruitment
Greece
Trial participating centre
Intensive Care Unit
Athens
11527
Greece
Sponsor information
Organisation
General State Hospital of Athens (Greece)
Sponsor details
Intensive Care Unit
154 Mesogeion Avenue
Athens
11527
Greece
+30 (0)210 7480188
icugg@otenet.gr
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
General State Hospital of Athens (Greece) - Intensive Care Unit
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17112371
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21494105
Publication citations
-
Results
Karakitsos D, Labropoulos N, De Groot E, Patrianakos AP, Kouraklis G, Poularas J, Samonis G, Tsoutsos DA, Konstadoulakis MM, Karabinis A, Real-time ultrasound-guided catheterisation of the internal jugular vein: a prospective comparison with the landmark technique in critical care patients., Crit Care, 2006, 10, 6, R162, doi: 10.1186/cc5101.
-
Results
Fragou M, Gravvanis A, Dimitriou V, Papalois A, Kouraklis G, Karabinis A, Saranteas T, Poularas J, Papanikolaou J, Davlouros P, Labropoulos N, Karakitsos D, Real-time ultrasound-guided subclavian vein cannulation versus the landmark method in critical care patients: a prospective randomized study., Crit. Care Med., 2011, 39, 7, 1607-1612, doi: 10.1097/CCM.0b013e318218a1ae.