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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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01877031
Enrollment
192
Registered
2013-06-13
Start date
2013-04-30
Completion date
2014-01-31
Last updated
2018-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Line Complication

Keywords

central line, ultrasound guided central line insertion, virtual reality, augmented reality

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.

Interventions

DEVICEVirtual 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.

DEVICEUltrasound

Standard of Care - Ultrasound guided intervention

Sponsors

University of Western Ontario, Canada
CollaboratorOTHER
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time taken to insert needlewithin 15 minutesMeasure the time taken from needle on skin to blood in syringe

Secondary

MeasureTime frameDescription
Attempts15 minutesMeasure the number of attempts taken to locate the internal jugular vein. Measured by the number of times the needle is advanced.
Carotid Puncturewithin 24 hoursRecord if the carotid artery was hit (clinical)
Pneumothorax24 hoursMonitor for pneumothorax after the procedure (clinical, Chest X-ray)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026