Virtual Reality With Ultrasound Versus Ultrasound For Central Line Insertion

NCT ID: NCT01877031

Last Updated: 2018-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-01-31

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.

Conditions

Central Line Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Ultrasound

Ultrasound only guidance of central line insertion - current standard of care.

Group Type: ACTIVE_COMPARATOR

Ultrasound

Intervention Type: DEVICE

Standard of Care - Ultrasound guided intervention

Virtual Reality

Use of ultrasound plus virtual reality guidance to insert central line

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Ultrasound

Standard of Care - Ultrasound guided intervention

Intervention Type: DEVICE

Other Intervention Names

Augmented reality

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Western Ontario, Canada

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Bainbridge, MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

Western University, Canada

Locations

London Health Sciences Center

London, Ontario, Canada

Countries

Canada

Other Identifiers

R-11-607

Identifier Type: -

Identifier Source: org_study_id