Effect of Environmental Temperature on Vascular Ultrasound Vein Scan Measurements

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Critical Limb Ischemia

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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Fiona Leahy, MSc; Phone Number: 0874525597; Email: fionac.leahy@hse.ie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Collaborators and Investigators

• Sponsor: University Hospital of Limerick
• Investigators: Principal Investigator: Zeeshan Ahmed, FRCS, Consultant Vascular Surgeon

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: December 20, 2023
• First Submitted That Met QC Criteria: December 20, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): May 4, 2025
• Last Update Submitted That Met QC Criteria: April 30, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Ischemia; Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia
• Other Study ID Numbers: DVS009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No