Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2025-12-17 @ 5:11 AM
Study NCT ID:
NCT06191237
Status:
None
Last Update Posted:
2025-05-04 00:00:00
First Post:
2023-12-20 00:00:00
Brief Title:
Effect of Environmental Temperature on Vascular Ultrasound Vein Scan Measurements
Sponsor:
University Hospital of Limerick
Organization:
University Hospital of Limerick
Study Overview
Official Title:
Effect of Environmental Temperature on Vascular Ultrasound Vein Scan Measurements
Status:
None
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
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 PI
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
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 PI
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None