Skip to main content
OpenTrials
Completed

NCT Number: NCT01877031

Virtual Reality With Ultrasound Versus Ultrasound For Central Line Insertion

We aim to compare the use of ultrasound guidance alone versus a magnetically tracked needle to look at the time taken to place a central line, or specifically the time taken to place a needle in the internal jugular vein prior to utilizing the Seldinger technique to insert a central line.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Central Line Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Health Sciences Center

London, Ontario, N6A 5A5, Canada

About this study

The purpose of this study is to examine the incremental benefit of a innovative, robust, intuitive and portable, virtual reality(VR) imaging platform capable of displaying a tracked virtual needle tip with path trajectory along with the real time ultrasound(US) image of an internal jugular vein compared to US imaging of the internal jugular vein alone to reduce the complications associated with insertion of central lines.

The studies primary outcome is the difference in time to insert a central line, from needle insertion to placement and confirmation of the wire in the internal jugular vein, compared to standard insertions using ultrasound guidance alone. Secondary outcomes will include the number of needle withdrawals, the incidence of carotid puncture and the incidence of pneumothorax. Finally, a subjective VAS rating of 1 to 10 for ease of insertion will be collected from participating anesthesiologists.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-80
  • Require a central line inserted in the left jugular vein
  • Undergoing surgery

Exclusion criteria

  • Contraindication to left jugular vein insertion (absent vein, infection at site)
  • Permanent or temporary pacemaker
  • Emergency surgery

Treatment and study plan

Virtual reality

Device

A magnetically tracked needle with an associated virtual image will be superimposed on the ultrasound image to give the user a better idea of the position of the needle.

Other names: Augmented reality

Ultrasound

Device

Standard of Care - Ultrasound guided intervention

Primary outcomes

  1. Time taken to insert needle

    Time frame: within 15 minutes

    Measure the time taken from needle on skin to blood in syringe

Secondary outcomes

  1. Attempts

    Time frame: 15 minutes

    Measure the number of attempts taken to locate the internal jugular vein. Measured by the number of times the needle is advanced.

  2. Carotid Puncture

    Time frame: within 24 hours

    Record if the carotid artery was hit (clinical)

  3. Pneumothorax

    Time frame: 24 hours

    Monitor for pneumothorax after the procedure (clinical, Chest X-ray)

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Collaborators

  • University of Western Ontario, Canada

Registry information

Official study title

Needle Guidance With Virtual Reality Augmented Ultrasound Versus Ultrasound Guidance Alone For Central Line Insertion: A Randomized Trial.

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Jun 13, 2013
Registry last updated
Nov 6, 2018

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.