Virtual Reality With Ultrasound Versus Ultrasound For Central Line Insertion

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

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.

Study Overview

• Status: Completed
• Conditions: Central Line Complication
• Intervention / Treatment: Device: Ultrasound; Device: Virtual Reality

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Center

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ultrasound; Ultrasound only guidance of central line insertion - current standard of care.	Device: Ultrasound; Standard of Care - Ultrasound guided intervention
Experimental: Virtual Reality; Use of ultrasound plus virtual reality guidance to insert central line	Device: Virtual Reality; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time taken to insert needle	Measure the time taken from needle on skin to blood in syringe	within 15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attempts	Measure the number of attempts taken to locate the internal jugular vein. Measured by the number of times the needle is advanced.	15 minutes
Carotid Puncture	Record if the carotid artery was hit (clinical)	within 24 hours
Pneumothorax	Monitor for pneumothorax after the procedure (clinical, Chest X-ray)	24 hours

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Collaborators: University of Western Ontario, Canada
• Investigators: Principal Investigator: Daniel Bainbridge, MD FRCPC, Western University, Canada

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: June 9, 2013
• First Submitted That Met QC Criteria: June 12, 2013
• First Posted (Estimate): June 13, 2013

Study Record Updates

• Last Update Posted (Actual): November 6, 2018
• Last Update Submitted That Met QC Criteria: November 2, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: augmented reality; virtual reality; central line; ultrasound guided central line insertion
• Other Study ID Numbers: R-11-607

Drug and device information, study documents

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