Virtual Reality With Ultrasound Versus Ultrasound For Central Line Insertion

Not Applicable

Completed

• Conditions: Central Line Complication
• Interventions: Device: Ultrasound; Device: Virtual Reality

• Registration Number: NCT01877031
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

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.

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 Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-06-09
• Study First Submitted QC: 2013-06-12
• Study First Posted: 2013-06-13
• Primary Completion: 2013-12
• Study Completion: 2014-01
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-02
• Last Update Posted: 2018-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound	Ultrasound	Ultrasound only guidance of central line insertion - current standard of care.
Virtual Reality	Virtual Reality	Use of ultrasound plus virtual reality guidance to insert central line

Primary Outcome Measures

Name	Time	Method
Time taken to insert needle	within 15 minutes	Measure the time taken from needle on skin to blood in syringe

Secondary Outcome Measures

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

Trial Locations

Locations (1)

London Health Sciences Center; 🇨🇦 London, Ontario, Canada