ISRCTN ISRCTN00203325
DOI https://doi.org/10.1186/ISRCTN00203325
Protocol serial number N/A
Sponsor "Attikon" Teaching Hospital (Greece) - University of Athens
Funder "Attikon" Teaching Hospital (Greece) - University of Athens
Submission date
19/03/2008
Registration date
08/04/2008
Last edited
08/04/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Theodore Liakakos
Scientific

"Attikon" Hospital
3rd Academic Department of Surgery
Haidari
Athens
124 10
Greece

Email theodlia@otenet.gr

Study information

Primary study designInterventional
Study designProspective randomised controlled trial
Secondary study designRandomised controlled trial
Scientific titleInternal jugular vein cannulation using ultrasound guidance: a prospective randomised controlled trial
Study objectivesReal time ultrasound guided cannulation of the internal jugular vein (IJV) is more efficient than catheterisation using ultrasound located landmarks.
Ethics approval(s)Ethics approval received from "Attikon" Hospital Ethics Committee on the 23rd January 2004 (ref: AP. 420/CP "ATTIKON" Hospital).
Health condition(s) or problem(s) studiedJugular vein cannulation
InterventionPatients 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 typeProcedure/Surgery
Primary outcome measure(s)

Success rate of cannulation, attempts less than or equal to three by the same operator.

Key secondary outcome measure(s)

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)

Completion date30/05/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit80 Years
SexAll
Target sample size at registration556
Key inclusion criteria1. Patients of the "Attikon" Hospital, in General Surgery, Oncology and Haematology Departments
2. Males and females, from 18 - 80 years of age
Key exclusion criteriaPatients with internal jugular vein thrombosis.
Date of first enrolment01/02/2004
Date of final enrolment30/05/2008

Locations

Countries of recruitment

  • Greece

Study participating centre

"Attikon" Hospital
Athens
124 10
Greece

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan