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Longitudinal or Transverse Orientation of Ultrasound Probe in Minimally Invasive Venous Surgery.

Primary Purpose

Varicose Veins, Endovenous Procedures, Venous Access

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Longitudinal
Transverse
Sponsored by
National University of Ireland, Galway, Ireland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Varicose Veins

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • For minimally invasive venous surgery of the lower limb (Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification score 2 of greater)
  • Intervention requiring venous cannulation of axial lower limb vein
  • Full consent
  • >18 years
  • No concomitant deep venous incompetence

Exclusion Criteria:

  • General anaesthesia

Sites / Locations

  • Saolta University Hospital Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Transverse Ultrasound Orientation

Longitudinal Ultrasound Orientation

Arm Description

Transverse placement of ultrasound to long axis of target lower limb vein

Longitudinal placement of ultrasound to long axis of target lower limb vein

Outcomes

Primary Outcome Measures

Overall successful Cannulation rate as a percentage
Overall successful cannulation of the target axial lower limb vein for endovenous treatment. Successful cannulation will be defined as intraluminal placement of the access cannula in the targeted axial vein.

Secondary Outcome Measures

Time in seconds to cannulation
Time from skin puncture to successful placement of access catheter in the target vein
Number of cannulation attempts
Number of times the skin is pierced in an attempt to cannulate the target vein
Peri-cannulation pain
Pain will be measured using a visual analogue scale of 0-100

Full Information

First Posted
July 24, 2019
Last Updated
March 25, 2020
Sponsor
National University of Ireland, Galway, Ireland
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1. Study Identification

Unique Protocol Identification Number
NCT04036734
Brief Title
Longitudinal or Transverse Orientation of Ultrasound Probe in Minimally Invasive Venous Surgery.
Official Title
Does Longitudinal or Transverse Orientation of Ultrasound Probe Improve Cannulation Success in Minimally Invasive Venous Surgery. A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
July 24, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Ireland, Galway, Ireland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Longitudinal ultrasound orientation during central venous cannulation has been suggested by a number of radomised studies to offer superior cannulation rates. This technique may offer a simple, safe and cost-neutral step to improve cannulation rates in the widely performed minimally invasive endovenous intervention.
Detailed Description
Varicose veins are an extremely common disorder and negatively impact on patient quality of life. In recent years minimally invasive venous treatments for varicose veins (MIVT) have emerged as an effective alternative to open surgery. It is associated with a reduction in peri-operative morbidity, recovery time and increased quality of life scores when compared with open surgical stripping4. Furthermore, MIVT is now widely carried out under local anaesthesia. Typically, MIVT requires cannulation, under ultrasound guidance, of either the great or small saphenous vein in the lower extremity to allow subsequent passage of a venous catheter. This cannulation technique is widely used for venous and arterial cannulation throughout the body. It entails utilising an ultrasound probe in either a longitudinal or transverse orientation (to the target vein) to guide an entry needle into a target vessel. The longitudinal orientation, while unstable, offers better visualisation of the vein when performed accurately. Conversely, the transverse approach is very stable with poorer visualisation of the target vessel. As such, no definitve guidance is available to guide treating physicians as to the optimal orientation with a wide variation among practitioners. The cannulation process for MIVT is often further challenged by both the small calibre and tendency toward vasospasm of target veins. Failure of cannulation may result in greater rates of conversion to open surgery exposing the patient to the the higher rate of morbidity associated with open surgery. More importantly, repeated cannulation results in significant discomfort and hence a reduction in patient satisfaction. Longitudinal ultrasound orientation during venous cannulation has been suggested by a number of radomised studies to offer superior cannulation rates of cannulation. This technique may offer a simple, safe and cost-neutral step to improve cannulation rates in the widely performed MIVT. The authors propose a blinded randomized controlled study to investigate the effects of ultrasound orietation on cannulation rates in MIVT. To test this hypothesis we plan to randomise 100 patients undergoing MIVT to either venous cannulation with transverse or longitudinal orientation of the ultrasound probe.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins, Endovenous Procedures, Venous Access

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallell block randomised groups
Masking
Participant
Masking Description
Intraoperative draping to obscure patient view
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transverse Ultrasound Orientation
Arm Type
Active Comparator
Arm Description
Transverse placement of ultrasound to long axis of target lower limb vein
Arm Title
Longitudinal Ultrasound Orientation
Arm Type
Experimental
Arm Description
Longitudinal placement of ultrasound to long axis of target lower limb vein
Intervention Type
Diagnostic Test
Intervention Name(s)
Longitudinal
Intervention Description
Longitudinal orientation of ultrasound to long axis of vein to guide access needle
Intervention Type
Diagnostic Test
Intervention Name(s)
Transverse
Intervention Description
Transverse orientation of ultrasound to long axis of vein to guide access needle
Primary Outcome Measure Information:
Title
Overall successful Cannulation rate as a percentage
Description
Overall successful cannulation of the target axial lower limb vein for endovenous treatment. Successful cannulation will be defined as intraluminal placement of the access cannula in the targeted axial vein.
Time Frame
Immediate
Secondary Outcome Measure Information:
Title
Time in seconds to cannulation
Description
Time from skin puncture to successful placement of access catheter in the target vein
Time Frame
Immediate
Title
Number of cannulation attempts
Description
Number of times the skin is pierced in an attempt to cannulate the target vein
Time Frame
Immediate
Title
Peri-cannulation pain
Description
Pain will be measured using a visual analogue scale of 0-100
Time Frame
Immediate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: For minimally invasive venous surgery of the lower limb (Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification score 2 of greater) Intervention requiring venous cannulation of axial lower limb vein Full consent >18 years No concomitant deep venous incompetence Exclusion Criteria: General anaesthesia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stewart R Walsh
Organizational Affiliation
National University of Ireland, Galway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saolta University Hospital Group
City
Galway
Country
Ireland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Longitudinal or Transverse Orientation of Ultrasound Probe in Minimally Invasive Venous Surgery.

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