Condition category
Respiratory
Date applied
10/04/2006
Date assigned
23/05/2006
Last edited
21/04/2011
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

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 measures

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

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes