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Physical ExaminationNCT06211946

Abdominal Aorta Palpation With Point of Care Ultrasound Imaging Measurements

An observational study of Physical Examination and Ultrasound Imaging, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
How many people
50 participants
Where
1 siteUnited States
Study dates
25 Jan 2024to 3 Apr 2024
Phase
Observational
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

Study population: Healthy adults over the age of 18

Who may be able to join

  • Healthy adults > 18 years of age

Who cannot join

  • History of abdominal aortic aneurysm.
  • Individuals that are pregnant or trying to become pregnant.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Mayo Clinic

    Rochester, Minnesota, 55904

Other trials in United States

About this study

Official title: Comparison of Abdominal Aorta Palpation With Point of Care Ultrasound Imaging Measurements in Healthy Individuals

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.
Read the detailed 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.

Keywords
Physical Therapy, Abdominal Screening, Ultrasound Imaging
Medical subject headings
Aortic Aneurysm, Abdominal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Palpation Measurement

    Palpated width of abdominal aorta will be measured using a tape measure.

    Measured: at baseline and within 1 month later

  2. Ultrasound Measurement

    Width of abdominal aorta will be measured using point of care ultrasound.

    Measured: at baseline and within 1 month later

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2024
  2. Study start25 Jan 2024
  3. Primary completion21 Mar 2024
  4. Study completion3 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06211946
Sponsor's protocol ID
23-009766
Status last verified
Apr 2024
First submitted
9 Jan 2024
Last updated
16 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Physical Examination and Ultrasound Imaging, run by Mayo Clinic at 1 site in United States.

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 1 inclusion and 2 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 16 Apr 2024. 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 United States. 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?

Palpation Measurement (time frame: at baseline and within 1 month later). The study lists 2 primary outcomes in all. 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 16 Apr 2024.

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