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.
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
- Conditions the study is for
- Physical Examination, Ultrasound Imaging, Abdominal Aortic Aneurysm
- 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.
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.
Palpation Measurement
Palpated width of abdominal aorta will be measured using a tape measure.
Measured: at baseline and within 1 month later
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.
- First posted18 Jan 2024
- Study start25 Jan 2024
- Primary completion21 Mar 2024
- Study completion3 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ExaminationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darren Q. Calley, Mayo Clinic
- Investigators
- Darren Calley, P.T., DScPT, OCS, Principal investigator, Mayo Clinic
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Abdominal Aorta Palpation With Point of Care Ultrasound Imaging Measurements in Healthy Individuals
- ClinicalTrials.gov ID
- NCT06211946
- Acronym / sponsor ID
- 23-009766
- Keywords
- Physical Therapy, Abdominal Screening, Ultrasound Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- 21 Mar 2024 (actual)
- Study completion
- 3 Apr 2024 (actual)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults over the age of 18
Key inclusion criteria (1 listed)
- Healthy adults > 18 years of age
Key exclusion criteria (2 listed)
- History of abdominal aortic aneurysm.
- Individuals that are pregnant or trying to become pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Palpation Measurement
Time frame: at baseline and within 1 month later
Palpated width of abdominal aorta will be measured using a tape measure.
Ultrasound Measurement
Time frame: at baseline and within 1 month later
Width of abdominal aorta will be measured using point of care ultrasound.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darren Calley, P.T., DScPT, OCS principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
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.