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.
1 other identifier
interventional
101
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2019
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
July 24, 2019
CompletedStudy Start
First participant enrolled
July 24, 2019
CompletedFirst Posted
Study publicly available on registry
July 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedMarch 26, 2020
March 1, 2020
7 months
July 24, 2019
March 25, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Immediate
Secondary Outcomes (3)
Time in seconds to cannulation
Immediate
Number of cannulation attempts
Immediate
Peri-cannulation pain
Immediate
Study Arms (2)
Transverse Ultrasound Orientation
ACTIVE COMPARATORTransverse placement of ultrasound to long axis of target lower limb vein
Longitudinal Ultrasound Orientation
EXPERIMENTALLongitudinal placement of ultrasound to long axis of target lower limb vein
Interventions
Longitudinal orientation of ultrasound to long axis of vein to guide access needle
Transverse orientation of ultrasound to long axis of vein to guide access needle
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- General anaesthesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Saolta University Hospital Group
Galway, Ireland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stewart R Walsh
National University of Ireland, Galway
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Intraoperative draping to obscure patient view
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Fellow Vascular Surgery
Study Record Dates
First Submitted
July 24, 2019
First Posted
July 30, 2019
Study Start
July 24, 2019
Primary Completion
March 1, 2020
Study Completion
March 1, 2020
Last Updated
March 26, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share