Virtual Reality With Ultrasound Versus Ultrasound For Central Line Insertion

Central Line Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01877031
• Other study ID #: R-11-607
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Est. completion date: January 2014

Study information

• Verified date: November 2018
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Central Line Complication

Intervention

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.
• Ultrasound
Standard of Care - Ultrasound guided intervention

Locations

Country	Name	City	State
Canada	London Health Sciences Center	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	University of Western Ontario, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time taken to insert needle	Measure the time taken from needle on skin to blood in syringe	within 15 minutes
Secondary	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
Secondary	Carotid Puncture	Record if the carotid artery was hit (clinical)	within 24 hours
Secondary	Pneumothorax	Monitor for pneumothorax after the procedure (clinical, Chest X-ray)	24 hours