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OpenTrials
Completed

NCT Number: NCT04036734

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saolta University Hospital Group

Galway, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Longitudinal

Diagnostic Test

Longitudinal orientation of ultrasound to long axis of vein to guide access needle

Transverse

Diagnostic Test

Transverse orientation of ultrasound to long axis of vein to guide access needle

Primary outcomes

  1. Overall successful Cannulation rate as a percentage

    Time frame: Immediate

    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 outcomes

  1. Time in seconds to cannulation

    Time frame: Immediate

    Time from skin puncture to successful placement of access catheter in the target vein

  2. Number of cannulation attempts

    Time frame: Immediate

    Number of times the skin is pierced in an attempt to cannulate the target vein

  3. Peri-cannulation pain

    Time frame: Immediate

    Pain will be measured using a visual analogue scale of 0-100

Sponsors and collaborators

Lead sponsor

National University of Ireland, Galway, Ireland

Other

Registry information

Official study title

Does Longitudinal or Transverse Orientation of Ultrasound Probe Improve Cannulation Success in Minimally Invasive Venous Surgery. A Randomized Controlled Trial.

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 30, 2019
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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