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Completed

NCT Number: NCT03130660

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IMS and SUM Hospital

Bhubaneswar, Odisha, 751007, India

About this study

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:

  • Insertion time: Time taken from 1st puncture of skin to insertion of guide wire into the vein.
  • Total Procedure time: Time from when Ultrasound scan was started to complete suturing of the CVC line.
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Lack of consent

Treatment and study plan

Ultrasonography

Device

Ultrasound guidance for central line

Primary outcomes

  1. time to insertion

    Time frame: 15 minutes

    time from skin puncture to insertion of guidewire

Secondary outcomes

  1. Total Procedure time

    Time frame: 15 minutes

    Time from when Ultrasound scan was started to complete suturing of the CVC line.

  2. Number of needle sticks

    Time frame: 15 minutes

    Number of time punctures were done in the skin

  3. Complications

    Time frame: 48 hours

    hematoma formation, posterior wall puncture, arterial puncture, extravasations of blood and pneumothorax

Sponsors and collaborators

Lead sponsor

Institute of Medical Sciences and SUM Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 26, 2017
Registry last updated
Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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