Short Versus Long Axis Ultrasound Guided Approach for Internal Jugular Vein Cannulations

Short Versus Long Axis Ultrasound Guided Approach for Internal Jugular Vein Cannulations: A Prospective Randomised Controlled Trial.

We plan to compare single person short axis view with two person long axis view

Study Overview

• Status: Completed
• Conditions: Ultrasonography; Central Line Complication
• Intervention / Treatment: Device: Ultrasonography

Detailed Description

Introduction: The guidelines for the use of bedside ultrasonography in the evaluation of critically ill patients published by the society of critical care medicine recommends short-axis view be used during insertion of central venous catheter (CVC) in internal jugular vein (IJV) to improve success rate1. The long axis view is considered better for cannulations as it helps in preventing posterior wall puncture but in the trials it has been found to be inconvenient for a single user2,3. We hypothesise that if two persons perform long axis cannulations i.e. one person will image the vein while the other punctures it will be equally convenient to single person doing the cannulations in short axis. The advantage we expect to see is lesser complications in long axis group.

Methodology:

Inclusion criteria: Any patient getting admitted to ICU and requiring central venous cannulations.

Exclusion: Lack of consent. Randomization: At a 1:1 ratio, to be achieved using a computer-generated random number sequence for 100 consecutive subjects Study intervention: Eligible patients will be randomized to a short-axis or long axis technique for ultrasound guided IJV cannulations. Ultrasound guidance will be performed dynamically using a single-operator technique for short axis and double operator technique for long axis view. Cannulations and USG is to be carried out by 2 trained Anaesthesiologists.

Definition:

1. Insertion time: Time taken from 1st puncture of skin to insertion of guide wire into the vein.
2. Total Procedure time: Time from when Ultrasound scan was started to complete suturing of the CVC line.
3. Number of needle sticks: Number of time punctures were done in the skin. Complications were noted as hematoma formation, posterior wall puncture, arterial puncture, extravasations of blood and pneumothorax.

All the times are to be noted by a bedside nurse who is not involved in the trial or knows the study hypothesis.

Statistical Analysis: An intention-to-treat analysis was performed. Insertion time, overall procedure time and number of needle sticks, and will be compared using Mann-Whitney U tests. The success rate and complication rate will be compared using Fisher exact tests. All statistical analyses will be performed with SPSS 20.0

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Odisha
    • Bhubaneswar, Odisha, India, 751007
      • IMS and SUM Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Any patient getting admitted to ICU and requiring central venous cannulations.

Exclusion Criteria:

• Lack of consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Short Axis Ultrasonography; one person does both ultrasound and line insertion	Device: Ultrasonography; Ultrasound guidance for central line
Experimental: Long Axis Ultrasonography; one person does ultrasound and another inserts the central line	Device: Ultrasonography; Ultrasound guidance for central line

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to insertion	time from skin puncture to insertion of guidewire	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Procedure time	Time from when Ultrasound scan was started to complete suturing of the CVC line.	15 minutes
Number of needle sticks	Number of time punctures were done in the skin	15 minutes
Complications	hematoma formation, posterior wall puncture, arterial puncture, extravasations of blood and pneumothorax	48 hours

Collaborators and Investigators

• Sponsor: Institute of Medical Sciences and SUM Hospital
• Investigators: Study Director: Arun Rath, MD, IMS and SUM Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2017
• Primary Completion (Actual): April 19, 2018
• Study Completion (Actual): April 19, 2018

Study Registration Dates

• First Submitted: April 22, 2017
• First Submitted That Met QC Criteria: April 25, 2017
• First Posted (Actual): April 26, 2017

Study Record Updates

• Last Update Posted (Actual): August 8, 2018
• Last Update Submitted That Met QC Criteria: August 7, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: central line; Central Line Complication
• Other Study ID Numbers: DMR/IMS.SH/SOA/170022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: We havent decided yet

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No