Use of Static Ultrasound Guidance for Internal Jugular Vein Cannulation in Adult Cardiac Surgical Patients

July 14, 2014 updated by: Dr Deepti Saigal, Govind Ballabh Pant Hospital

Comparison of the Landmark Technique and the Static Ultrasound Guided Technique for Internal Jugular Vein Cannulation in Adult Cardiac Surgical Patients.

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.

Study Overview

Detailed Description

Use of real time ultrasound has recently been recommended as the standard of care for insertion of central venous catheters. However, its usage is limited by various factors which include availability, space constraints and perceived lack of need according to surveys including cardiovascular anesthesiologists. We will conduct a prospective randomized controlled trial to compare the conventional landmark technique with the static ultrasound (US) technique that utilized the transthoracic echocardiography (TTE) ultrasound probe which is supplied along with the transesophageal echocardiography machines for internal jugular vein cannulation in adult cardiac surgical patients.

After ethical committee approval and patient consent, adult patients scheduled for elective cardiac surgery will be randomized to undergo internal jugular vein cannulation by either of the two methods: standard landmark technique (group A: control group), static US technique using the TTE probe (group B: ultrasound group). The success rate, number of attempts, total cannulation time and complication rate in the two groups will be compared.

Study Type

Interventional

Enrollment (Actual)

201

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Delhi
      • New Delhi, Delhi, India, 110002
        • Department of Anesthesia and Intensive Care, Govind Ballabh Pant Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients scheduled for elective cardiac surgery

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Landmark technique
The landmark technique is the standard technique used for internal jugular vein cannulation.
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.
Experimental: Static Ultrasound technique
Static ultrasound technique was used to assist internal jugular vein cannulation.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
success
Time Frame: during internal jugular venous cannulation
Success was defined as location of the IJV by the finder needle within five attempts.
during internal jugular venous cannulation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of attempts by finder/locator needle
Time Frame: at the time of internal jugular vein cannulation
The total number of attempts taken to locate the internal jugular vein using the locator/finder needle were measured.
at the time of internal jugular vein cannulation
total number of attempts by puncture needle
Time Frame: at the time of internal jugular vein cannulation
The total number of attempts taken by the puncture needle to enter the internal jugular vein were measured.
at the time of internal jugular vein cannulation
First attempt sucess
Time Frame: at the time of internal jugular vein cannulation
First attempt success was defined as location of the IJV by finder needle in the first attempt.
at the time of internal jugular vein cannulation
Central venous cannulation time
Time Frame: at the time of internal jugular venous cannulation
Time to central venous cannulation (CVC) was defined as the time taken from the insertion of finder needle till de-airing and flushing of all the three ports of the triple lumen catheter.
at the time of internal jugular venous cannulation
ultrasound time
Time Frame: at the time of internal jugular vein cannulation
The duration of ultrasound was defined as the time between the placement of the probe on neck till the marking of the course of the vein on the skin.
at the time of internal jugular vein cannulation
total cannulation time
Time Frame: at the time of internal jugular vein cannulation
control group: total cannulation time= central venous cannulation time ultrasound group: total cannulation time= central venous cannulation time+ ultrasound time
at the time of internal jugular vein cannulation
complication rate
Time Frame: at the time of central venous cannulation
The complication rate was calculated as a percentage of the total number of complications with respect to the sample size
at the time of central venous cannulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Deepak Tempe, MD, Govind Ballabh pant Hospital and Maulana azad Medical College, New Delhi, India

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

July 4, 2014

First Submitted That Met QC Criteria

July 8, 2014

First Posted (Estimate)

July 9, 2014

Study Record Updates

Last Update Posted (Estimate)

July 15, 2014

Last Update Submitted That Met QC Criteria

July 14, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • F.2/IEC/MAMC/11/No.96

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Adult Cardiac Surgical Patients

Clinical Trials on landmark technique

3
Subscribe