Virtual Reality With Ultrasound Versus Ultrasound For Central Line Insertion

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Central Line Complication

Intervention / Treatment
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* Device: Virtual Reality
* Device: Ultrasound


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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central line, ultrasound guided central line insertion, virtual reality, augmented reality