NCT02185664

Brief Summary

Cannulation of the internal jugular vein (IJV) for central venous access is a standard practice in cardiac surgery. In this study, the authors tested the hypothesis that using an ultrasound (US) scanner would increase the success of IJV cannulation and decrease the incidence of complications in adult cardiac surgical patients. The study will include adult cardiac surgical patients, randomized into two groups (control vs. US). In the control group, IJV cannulation will be performed by the conventional landmark technique using Seldinger method. In the US group, the course of the IJV will be marked before cannulation using a 2 - 4 MHz transthoracic echocardiography probe. The success rate, number of attempts, cannulation time and complication rate will be compared for the two groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 9, 2014

Completed
Last Updated

July 15, 2014

Status Verified

July 1, 2014

Enrollment Period

1 year

First QC Date

July 4, 2014

Last Update Submit

July 14, 2014

Conditions

Keywords

internal jugular veinlandmarkultrasoundstaticcardiac surgery

Outcome Measures

Primary Outcomes (1)

  • success

    Success was defined as location of the IJV by the finder needle within five attempts.

    during internal jugular venous cannulation

Secondary Outcomes (7)

  • number of attempts by finder/locator needle

    at the time of internal jugular vein cannulation

  • total number of attempts by puncture needle

    at the time of internal jugular vein cannulation

  • First attempt sucess

    at the time of internal jugular vein cannulation

  • Central venous cannulation time

    at the time of internal jugular venous cannulation

  • ultrasound time

    at the time of internal jugular vein cannulation

  • +2 more secondary outcomes

Study Arms (2)

Landmark technique

ACTIVE COMPARATOR

The landmark technique is the standard technique used for internal jugular vein cannulation.

Procedure: landmark technique

Static Ultrasound technique

EXPERIMENTAL

Static ultrasound technique was used to assist internal jugular vein cannulation.

Device: Static Ultrasound technique

Interventions

The apex of the imaginary triangle formed between the two heads of sternocleidomastoid and clavicle was used as the point of needle entry, just lateral to the pulsation of the internal carotid artery and directed towards the ipsilateral nipple at an angle of 45 degrees.

Landmark technique

Static ultrasound guided internal jugular vein cannulation was performed by using the transthoracic echocardiography probe supplied with the transesophageal echocardiography machine in the cardiothoracic surgery operation theatre. The internal jugular vein was located and marked using this method prior to puncture.

Static Ultrasound technique

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients scheduled for elective cardiac surgery

You may not qualify if:

  • patients undergoing bidirectional Glenn shunt, Fontan surgery or emergency surgery
  • local site infection
  • presence of coagulopathy
  • anatomical deformity of neck(burns, neck swelling, surgical scar)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesia and Intensive Care, Govind Ballabh Pant Hospital

New Delhi, National Capital Territory of Delhi, 110002, India

Location

Related Publications (3)

  • Espinet A, Dunning J. Does ultrasound-guided central line insertion reduce complications and time to placement in elective patients undergoing cardiac surgery. Interact Cardiovasc Thorac Surg. 2004 Sep;3(3):523-7. doi: 10.1016/j.icvts.2004.05.006.

    PMID: 17670301BACKGROUND
  • Bailey PL, Glance LG, Eaton MP, Parshall B, McIntosh S. A survey of the use of ultrasound during central venous catheterization. Anesth Analg. 2007 Mar;104(3):491-7. doi: 10.1213/01.ane.0000255289.78333.c2.

    PMID: 17312193BACKGROUND
  • Hind D, Calvert N, McWilliams R, Davidson A, Paisley S, Beverley C, Thomas S. Ultrasonic locating devices for central venous cannulation: meta-analysis. BMJ. 2003 Aug 16;327(7411):361. doi: 10.1136/bmj.327.7411.361.

Study Officials

  • Deepak Tempe, MD

    Govind Ballabh pant Hospital and Maulana azad Medical College, New Delhi, India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 4, 2014

First Posted

July 9, 2014

Study Start

April 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

July 15, 2014

Record last verified: 2014-07

Locations