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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04036734
Enrollment
101
Registered
2019-07-30
Start date
2019-07-24
Completion date
2020-03-01
Last updated
2020-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endovenous Procedures, Varicose Veins, Venous Access

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.

Interventions

DIAGNOSTIC_TESTLongitudinal

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

DIAGNOSTIC_TESTTransverse

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

Sponsors

National University of Ireland, Galway, Ireland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Intraoperative draping to obscure patient view

Intervention model description

Parallell block randomised groups

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Overall successful Cannulation rate as a percentageImmediateOverall 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

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

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026