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Clinical Trials/NCT01877031
NCT01877031
Completed
Not Applicable

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

Lawson Health Research Institute1 site in 1 country192 target enrollmentApril 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Central Line Complication
Sponsor
Lawson Health Research Institute
Enrollment
192
Locations
1
Primary Endpoint
Time taken to insert needle
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2013
End Date
January 2014
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Time taken to insert needle

Time Frame: within 15 minutes

Measure the time taken from needle on skin to blood in syringe

Secondary Outcomes

  • Carotid Puncture(within 24 hours)
  • Attempts(15 minutes)
  • Pneumothorax(24 hours)

Study Sites (1)

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