Contact information
Type
Scientific
Primary contact
Prof Theodore Liakakos
ORCID ID
Contact details
"Attikon" Hospital
3rd Academic Department of Surgery
Haidari
Athens
124 10
Greece
theodlia@otenet.gr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Internal jugular vein cannulation using ultrasound guidance: a prospective randomised controlled trial
Acronym
Study hypothesis
Real time ultrasound guided cannulation of the internal jugular vein (IJV) is more efficient than catheterisation using ultrasound located landmarks.
Ethics approval
Ethics approval received from "Attikon" Hospital Ethics Committee on the 23rd January 2004 (ref: AP. 420/CP "ATTIKON" Hospital).
Study design
Prospective randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Jugular vein cannulation
Intervention
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.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Success rate of cannulation, attempts less than or equal to three by the same operator.
Secondary outcome measures
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)
Overall trial start date
01/02/2004
Overall trial end date
30/05/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients of the "Attikon" Hospital, in General Surgery, Oncology and Haematology Departments
2. Males and females, from 18 - 80 years of age
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
212 - 556
Participant exclusion criteria
Patients with internal jugular vein thrombosis.
Recruitment start date
01/02/2004
Recruitment end date
30/05/2008
Locations
Countries of recruitment
Greece
Trial participating centre
"Attikon" Hospital
Athens
124 10
Greece
Sponsor information
Organisation
"Attikon" Teaching Hospital (Greece) - University of Athens
Sponsor details
1 Rimini Str
Haidari
Athens
124 10
Greece
gchklin@med.uoa.gr
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
"Attikon" Teaching Hospital (Greece) - University of Athens
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
Results - basic reporting
Publication summary