Condition category
Surgery
Date applied
19/03/2008
Date assigned
08/04/2008
Last edited
08/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes