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

NCT ID: NCT03130660

Last Updated: 2018-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-20
• Study Completion Date: 2018-04-19

Brief Summary

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

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

Conditions

Ultrasonography; Central Line Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Short Axis Ultrasonography

one person does both ultrasound and line insertion

Group Type: EXPERIMENTAL

Ultrasonography

Intervention Type: DEVICE

Ultrasound guidance for central line

Long Axis Ultrasonography

one person does ultrasound and another inserts the central line

Group Type: EXPERIMENTAL

Ultrasonography

Intervention Type: DEVICE

Ultrasound guidance for central line

Interventions

Ultrasonography

Ultrasound guidance for central line

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Lack of consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Medical Sciences and SUM Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shakti Bedanta Mishra

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arun Rath, MD

Role: STUDY_DIRECTOR

IMS and Sum hospital

Locations

IMS and SUM Hospital

Bhubaneswar, Odisha, India

Countries

India

Other Identifiers

DMR/IMS.SH/SOA/170022

Identifier Type: -

Identifier Source: org_study_id