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

Ultrasonography Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03130660
• Other study ID #: DMR/IMS.SH/SOA/170022
• Status: Completed
• Phase: N/A
• Start date: April 20, 2017
• Est. completion date: April 19, 2018

Study information

• Verified date: August 2018
• Source: Institute of Medical Sciences and SUM Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 19, 2018
• Est. primary completion date: April 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Lack of consent

Related Conditions & MeSH terms

• Central Line Complication
• Ultrasonography

Intervention

Device:
• Ultrasonography
Ultrasound guidance for central line

Locations

Country	Name	City	State
India	IMS and SUM Hospital	Bhubaneswar	Odisha

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Medical Sciences and SUM Hospital

Country where clinical trial is conducted

India, 

Outcome

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