Varicose VeinsNCT04036734
Longitudinal or Transverse Orientation of Ultrasound Probe in Minimally Invasive Venous Surgery.
A study testing Longitudinal and Transverse in people with Varicose Veins and Endovenous Procedures, run by National University of Ireland, Galway, Ireland at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Varicose Veins, Endovenous Procedures, Venous Access
- What is being tested?
- Longitudinal and Transverse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteIreland
- Study dates
- 24 Jul 2019to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- General anaesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Longitudinal or Transverse Orientation of Ultrasound Probe Improve Cannulation Success in Minimally Invasive Venous Surgery. A Randomized Controlled Trial.
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.
Read the 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
- Being tested
- Longitudinal, Transverse
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LongitudinalDiagnostic test
Longitudinal orientation of ultrasound to long axis of vein to guide access needle
TransverseDiagnostic test
Transverse orientation of ultrasound to long axis of vein to guide access needle
| Study group | Role | What they receive |
|---|---|---|
| Transverse Ultrasound Orientation | Active comparator | Transverse placement of ultrasound to long axis of target lower limb vein Receives: Diagnostic Test: Transverse |
| Longitudinal Ultrasound Orientation | Experimental | Longitudinal placement of ultrasound to long axis of target lower limb vein Receives: Diagnostic Test: Longitudinal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediate
Secondary outcomes (3)
Time in seconds to cannulation
Time from skin puncture to successful placement of access catheter in the target vein
Measured: Immediate
Number of cannulation attempts
Number of times the skin is pierced in an attempt to cannulate the target vein
Measured: Immediate
Peri-cannulation pain
Pain will be measured using a visual analogue scale of 0-100
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start24 Jul 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallell block randomised groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Ireland, Galway, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Aherne, National University of Ireland, Galway, Ireland
- Investigators
- Stewart R Walsh, Principal investigator, National University of Ireland, Galway, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036734
- Sponsor's protocol ID
- USGSV
- Status last verified
- Mar 2020
- First submitted
- 24 Jul 2019
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Longitudinal or Transverse Orientation of Ultrasound Probe Improve Cannulation Success in Minimally Invasive Venous Surgery. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04036734
- Acronym / sponsor ID
- USGSV
- Conditions
- Varicose Veins, Endovenous Procedures, Venous Access
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- National University of Ireland, Galway, IrelandUniversity, hospital or other
- Study start
- 24 Jul 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 30 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallell block randomised groups
| Arm | Type | Receives |
|---|---|---|
| Transverse Ultrasound Orientation | Active comparator | Diagnostic Test: TransverseTransverse placement of ultrasound to long axis of target lower limb vein |
| Longitudinal Ultrasound Orientation | Experimental | Diagnostic Test: LongitudinalLongitudinal placement of ultrasound to long axis of target lower limb vein |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- General anaesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LongitudinalLongitudinal orientation of ultrasound to long axis of vein to guide access needle | Diagnostic test | Longitudinal Ultrasound Orientation |
| TransverseTransverse orientation of ultrasound to long axis of vein to guide access needle | Diagnostic test | Transverse Ultrasound Orientation |
Primary outcome
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.
3 secondary outcomes
Time in seconds to cannulation
Time frame: Immediate
Number of cannulation attempts
Time frame: Immediate
Peri-cannulation pain
Time frame: Immediate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stewart R Walsh principal investigator
National University of Ireland, Galway, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Longitudinal and Transverse in people with Varicose Veins and Endovenous Procedures, run by National University of Ireland, Galway, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall successful Cannulation rate as a percentage (time frame: Immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.