Clinical Trials Logo

Clinical Trial Summary

The goal of this observational study is to compare the measurements of abdominal aorta width via palpation and point of care ultrasound imaging in healthy individuals. The main question[s] it aims to answer are: - Is there a measurement difference in abdominal aorta width in healthy individuals as measured by palpation and point of care ultrasound imaging? - Are palpation measurements and point of care ultrasound imaging measurements reliable when performed by physical therapy researchers? Participants will be asked to have their abdominal area be palpated around the umbilicus and will have ultrasound imaging performed over their abdominal aorta area. It is anticipated participation in the study will take less than 15 minutes. Subjects will be asked to return for a repeat visit within 1 month to determine reliability of measurements.


Clinical Trial Description

As part of a review of systems to screen for non-musculoskeletal low back pain, physical therapists perform an abdominal screening exam which may include observation and palpation of the abdominal aorta. Using a two-finger distance palpation method, an estimation of the abdominal aorta width is one screening approach. A growing part of physical therapy practice is use of point of care ultrasound imaging (POCUS) to guide a physical therapy diagnosis and assist with clinical reasoning. No published research could be found on physical therapists using diagnostic ultrasound imaging to measure the abdominal aorta distance, or intra-reliability in palpation of abdominal aorta transverse distance. A measurement in excess of 3 cm is typically characterized as an abdominal aortic aneurism. The goal of this study is to determine the reliability and agreement of abdominal aorta palpation measurements with transverse diameter abdominal aorta POCUS measurements performed by physical therapy researchers in healthy individuals. Healthy patients over the age of 18 without a history of abdominal aortic aneurisms will be recruited for a study with 2 visits within 1 month of each other at Mayo Clinic Rochester. Patients will undergo a brief survey of basic demographic information including age, sex, and race/ethnicity at first visit only. The patients will also have their height and weight taken by the examiners to determine BMI. The order of testing will be randomly allocated. Patients will lie supine in the hook-lying position with the abdomen exposed to the xiphoid process. Study Examiner 1 will take a two-finger palpation measurement of the abdominal aorta, just cranial to the umbilicus and caudal to the xyphoid using a tape measure. For the palpation measurement, the examiner will be blinded to the numerical measurement and another examiner will measure and record the distance. Study Examiner 2 will then perform transverse infra-renal [above the umbilicus and slightly left] abdominal aorta ultrasound using Vscan Air™ ultrasound imaging device. A short axis view of the abdominal aorta will be captured on screen with the borders of the aorta clearly outlined. Using digital calipers, the largest aorta diameter from outer lumen to outer lumen will be measured. Examiner 2 will be blinded to the actual ultrasound measurement, and the measurement will be read and recorded by another examiner. Subjects will return for a follow-up visit to repeat the above process within 1 month to capture intra-rater reliability. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06211946
Study type Observational
Source Mayo Clinic
Contact
Status Completed
Phase
Start date January 25, 2024
Completion date April 3, 2024

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04227054 - Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks N/A
Active, not recruiting NCT03687489 - Safety and Efficacy Study of Abdominal Aortic Aneurysm Stent Graft System N/A
Active, not recruiting NCT03507413 - Metformin Therapy in Non-diabetic AAA Patients Phase 2/Phase 3
Not yet recruiting NCT05756283 - The PREHAAAB Trial: Multimodal Prehabilitation for Patients Awaiting Open Abdominal Aortic Aneurysm Repair N/A
Not yet recruiting NCT04089241 - Fusion of CT Angiography With 3D Contrast Ultrasound as a Method for Follow up for Endovascular Aneurysm Repair N/A
Active, not recruiting NCT02604303 - A Prospective Analysis on the Expansion Rates of Abdominal Aortic Aneurysms
Completed NCT02229006 - Sodium Fluoride Imaging of Abdominal Aortic Aneurysms N/A
Terminated NCT01843335 - Contrast-enhanced Ultrasound in Follow-up After Endovascular Aneurysm Repair N/A
Completed NCT02224794 - LIFE Study: Least Invasive Fast-Track EVAR
Terminated NCT02469376 - Evaluation of a New Imagingtechnologie for Thrombosis Phase 1
Terminated NCT01425242 - Study on Anti-inflammatory Effect of Anti-hypertensive Treatment in Patients With Small AAA's and Mild Hypertension N/A
Completed NCT01118520 - AARDVARK (Aortic Aneurysmal Regression of Dilation: Value of ACE-Inhibition on RisK) Phase 2
Completed NCT00746122 - Immediate Management of the Patient With Rupture : Open Versus Endovascular Repair N/A
Completed NCT03952780 - Korean Registry of Percutaneous EVAR With INCRAFT Stent Graft for the Treatment of Abdominalaortic Aneurysm (K-INCRAFT)
Completed NCT00583414 - Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients N/A
Recruiting NCT05864560 - Ankura™ AAA, Cuff and AUI Stent Graft System Post-Market Clinical Follow-Up
Completed NCT01683084 - Study of the Effectiveness of Telmisartan in Slowing the Progression of Abdominal Aortic Aneurysms Phase 4
Active, not recruiting NCT03180996 - Global Fenestrated Anaconda Clinical sTudy
Completed NCT02493296 - The Effect of Surgery on Central Aortic Pressure & haEmodynamics Study
Completed NCT03320408 - Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers