ISRCTN ISRCTN00203325
DOI https://doi.org/10.1186/ISRCTN00203325
Secondary identifying numbers N/A
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

Study designProspective randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
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 measureSuccess rate of cannulation, attempts less than or equal to three by the same operator.
Secondary outcome measures1. 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 study start date01/02/2004
Completion date30/05/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit80 Years
SexBoth
Target number of participants212 - 556
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

Sponsor information

"Attikon" Teaching Hospital (Greece) - University of Athens
Hospital/treatment centre

1 Rimini Str
Haidari
Athens
124 10
Greece

Email gchklin@med.uoa.gr
ROR logo "ROR" https://ror.org/03gb7n667

Funders

Funder type

Hospital/treatment centre

"Attikon" Teaching Hospital (Greece) - University of Athens

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan