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Not yet recruitingNCT06191237Updated May 4, 2025

Effect of Environmental Temperature on Vascular Ultrasound Vein Scan Measurements

An observational study in Critical Limb Ischemia, sponsored by University Hospital of Limerick. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-04.

Sponsored by University Hospital of Limerick · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study summary

We wish to conduct two vascular ultrasound scans conducting vein measurements in two separate scanning rooms to assess if environmental temperature affects the vein diameter recorded.

Read the detailed description

Vascular surgeons are guided by vascular ultrasound scans when deciding treatment plans for their patients. In critical limb threatening ischaemia with infrainguinal disease, vein bypass has the best limb salvage and long term survival rates in patients who are appropriately selected. In lower limb "vein mapping", the vein is measured to assess suitability for use as a bypass conduit with the favoured bypass conduit being autologous, ipsilateral vein of good quality and length and a size of >3mm is considered a good conduit.

The research team found one study which explored the effect of room temperature on upper limb vein measurements which was conducted in Singapore. This showed an underestimation of vein size at lower temperatures. We wish to add to the literature and irish research by conducting this study at University Hospital Limerick in order to optimise conditions for vascular assessments and therefore facilitate clinical decision making.

We aim to scan and record vein measurements on the lower limbs of vascular inpatients at University Hospital Limerick who are deemed suitable by the P.I.

Patients will have the ultrasound scan completed twice. The first room will have its temperature recorded and the vein measurements taken.

The second room will be set at a higher temperature which we have defined as being 6-10 degrees greater than ambient room temperature. We will achieve this through use of a portable heater.

We will compare the two recordings to assess if there is a difference in the diameter of the vein measured in the warmer room versus the standard room.

The importance of this is to assess the impact of environmental factors on vascular ultrasound scan results, therefore impacting on patient outcomes by use of the most suitable bypass conduit.

02

Conditions studied

  • Critical Limb Ischemia
03

In context

Chronic Limb-Threatening Ischemia

343 studies on the registry are indexed under Chronic Limb-Threatening Ischemia; 70 are open to participants now.

This study's planned enrollment of 30 is below the median of 123 across 98 observational studies indexed under Chronic Limb-Threatening Ischemia.

Browse Chronic Limb-Threatening Ischemia studies →

Lead sponsor

University Hospital of Limerick is the lead sponsor of 15 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Those who meet inclusion criteria under the care of a Consultant Vascular Surgeon with no varicose veins/venous insufficiency will have vascular ultrasound vein scans performed and measurements recorded.

Inclusion criteria

  • Inpatient at University Hospital Limerick under the care of a Vascular Consultant
  • Aged 18 years and above
  • Deemed suitable for two vascular ultrasound scans by the P.I

Exclusion criteria

Exclusion Criteria:

  • Those unable to give informed consent
  • Aged under 18 years
  • Patients with varicose veins/venous insufficiency
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Vein diameter measurements in two temperature controlled rooms

    Two vascular ultrasound scans will be performed on the lower limb. A defined scanning protocol will be adhered to which will ensure consistency and accuracy. During the course of both ultrasound scans, vein measurements will be taken and recorded on the study sheet which will have the participant study identification number, age and gender. The second room will be set at a higher temperature which we have defined as being 6-10 degrees greater than ambient room temperature.

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06191237
Lead sponsor
University Hospital of Limerick
Responsible party
Fiona Leahy (Mr Zeeshan Ahmed Consultant vascular Surgeon, University Hospital of Limerick) — Principal investigator
First posted
Jan 5, 2024
Start date
Sep 1, 2025 (estimated)
Primary completion
Sep 1, 2025 (estimated)
Completion
Sep 1, 2025 (estimated)
Last update
May 4, 2025

Study contacts

Fiona Leahy, MSc
Contact
fionac.leahy@hse.ie
0874525597
Zeeshan Ahmed, FRCS
principal investigator · Consultant Vascular Surgeon

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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