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

NCT ID: NCT04036734

Last Updated: 2020-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-24
• Study Completion Date: 2020-03-01

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.

Conditions

Varicose Veins; Endovenous Procedures; Venous Access

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Transverse Ultrasound Orientation

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

Group Type: ACTIVE_COMPARATOR

Transverse

Intervention Type: DIAGNOSTIC_TEST

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

Longitudinal Ultrasound Orientation

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

Group Type: EXPERIMENTAL

Longitudinal

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Longitudinal

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

Intervention Type: DIAGNOSTIC_TEST

Transverse

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

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National University of Ireland, Galway, Ireland

OTHER

Sponsor Role: lead

Responsible Party

Thomas Aherne

Research Fellow Vascular Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stewart R Walsh

Role: PRINCIPAL_INVESTIGATOR

National University of Ireland, Galway

Locations

Saolta University Hospital Group

Galway, , Ireland

Countries

Ireland

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

USGSV

Identifier Type: -

Identifier Source: org_study_id