NCT01877031

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 13, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

November 6, 2018

Status Verified

November 1, 2018

Enrollment Period

8 months

First QC Date

June 9, 2013

Last Update Submit

November 2, 2018

Conditions

Central Line Complication

Keywords

central lineultrasound guided central line insertionvirtual realityaugmented reality

Outcome Measures

Primary Outcomes (1)

  • Time taken to insert needle

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

    within 15 minutes

Secondary Outcomes (3)

  • Attempts

    15 minutes

  • Carotid Puncture

    within 24 hours

  • Pneumothorax

    24 hours

Study Arms (2)

Ultrasound

ACTIVE COMPARATOR

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

Device: Ultrasound

Virtual Reality

EXPERIMENTAL

Use of ultrasound plus virtual reality guidance to insert central line

Device: Virtual Reality

Interventions

Virtual RealityDEVICE

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.

Also known as: Augmented reality
Virtual Reality
UltrasoundDEVICE

Standard of Care - Ultrasound guided intervention

Ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-80
  • Require a central line inserted in the left jugular vein
  • Undergoing surgery

You may not qualify if:

  • Contraindication to left jugular vein insertion (absent vein, infection at site)
  • Permanent or temporary pacemaker
  • Emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Center

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Daniel Bainbridge, MD FRCPC

    Western University, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2013

First Posted

June 13, 2013

Study Start

April 1, 2013

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

November 6, 2018

Record last verified: 2018-11

Locations

CA(1)