FrailtyNCT05438628
Preoperative Frailty Assessment With Ultrasound in Elderly Patients
An observational study of Frailty, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
In this study, the investigators aim to evaluate the prediction accuracy of the thickness measured with point-of-care ultrasound of the rectus abdominis, biceps brachii muscles of frailty. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty
- What is being tested?
- Point of care ultrasound
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Jul 2022to 30 Dec 2022
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients 60 years old or older scheduled for total knee arthroplasty
Who may be able to join
- Patients 60 years old or older scheduled for total knee arthroplasty
Who cannot join
- Unable to communicate with the patient or the patient's guardian
- Myopathy
- History of injury of rectus abdominis, biceps brachii or quadriceps femoris muscle.
- History of total knee arthroplasty in the recent 3 months prior to surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Jongno-gu, 03080
About this study
Official title: Preoperative Frailty Assessment With Point-of-care Ultrasound in Elderly Patients Scheduled for Total Knee Arthroplasty
In this study, the investigators aim to evaluate the prediction accuracy of the thickness measured with point-of-care ultrasound of the rectus abdominis, biceps brachii muscles of frailty.
- Conditions
- Frailty
- Being tested
- Point of care ultrasound
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of care ultrasoundDiagnostic test
Measurement of thickness of rectus abdominis, biceps brachii muscles
| Study group | Role | What they receive |
|---|---|---|
| Patients scheduled for total knee arthroplasty surgery | Not described Receives: Diagnostic Test: Point of care ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction accuracy of the thickness of rectus abdominis, biceps brachii muscles measured with point of care ultrasound
Measured: Preoperative evaluation
Secondary outcomes (13)
Thickness of quadratus femoris muscle measured with point-of care ultrasound
Measured: Preoperative evaluation
Circumference of thigh
Measured: Preoperative evaluation
Difference between thickness of left and right rectus abdominis muscles
Measured: Preoperative evaluation
Difference between thickness of left and right biceps brachii muscles
Measured: Preoperative evaluation
Difference between thickness of left and right quadriceps femoris muscles
Measured: Preoperative evaluation
Unplanned ICU admission
Measured: First 30 days post surgery
Unplanned discharge to nursing facility
Measured: First 30 days post surgery
Incidence of postoperative delirium
Measured: First 30 days post surgery
ICU stay duration
Measured: First 30 days post surgery
Total length of stay
Measured: First 30 days post surgery
Number of falls
Measured: First 30 days post surgery
Readmission in the 30-day postoperative period
Measured: First 30 days post surgery
Mortality
Measured: First 30 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start4 Jul 2022
- Primary completion13 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438628
- Sponsor's protocol ID
- 2206-089-1332
- Status last verified
- Feb 2023
- First submitted
- 22 Jun 2022
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Frailty Assessment With Point-of-care Ultrasound in Elderly Patients Scheduled for Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05438628
- Acronym / sponsor ID
- 2206-089-1332
- Conditions
- Frailty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- 13 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 30 Jun 2022 (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.
In this study, the investigators aim to evaluate the prediction accuracy of the thickness measured with point-of-care ultrasound of the rectus abdominis, biceps brachii muscles of frailty.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients scheduled for total knee arthroplasty surgery | – | Diagnostic Test: Point of care ultrasound |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 60 years old or older scheduled for total knee arthroplasty
Key inclusion criteria (1 listed)
- Patients 60 years old or older scheduled for total knee arthroplasty
Key exclusion criteria (4 listed)
- Unable to communicate with the patient or the patient's guardian
- Myopathy
- History of injury of rectus abdominis, biceps brachii or quadriceps femoris muscle.
- History of total knee arthroplasty in the recent 3 months prior to surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point of care ultrasoundMeasurement of thickness of rectus abdominis, biceps brachii muscles | Diagnostic test | Patients scheduled for total knee arthroplasty surgery |
Primary outcome
Prediction accuracy of the thickness of rectus abdominis, biceps brachii muscles measured with point of care ultrasound
Time frame: Preoperative evaluation
13 secondary outcomes
Thickness of quadratus femoris muscle measured with point-of care ultrasound
Time frame: Preoperative evaluation
Circumference of thigh
Time frame: Preoperative evaluation
Difference between thickness of left and right rectus abdominis muscles
Time frame: Preoperative evaluation
Difference between thickness of left and right biceps brachii muscles
Time frame: Preoperative evaluation
Difference between thickness of left and right quadriceps femoris muscles
Time frame: Preoperative evaluation
Unplanned ICU admission
Time frame: First 30 days post surgery
Unplanned discharge to nursing facility
Time frame: First 30 days post surgery
Incidence of postoperative delirium
Time frame: First 30 days post surgery
ICU stay duration
Time frame: First 30 days post surgery
Total length of stay
Time frame: First 30 days post surgery
Number of falls
Time frame: First 30 days post surgery
Readmission in the 30-day postoperative period
Time frame: First 30 days post surgery
Mortality
Time frame: First 30 days post surgery
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 22 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Frailty, run by Seoul National University Hospital at 1 site in South Korea.
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 4 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 22 Feb 2023. 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 South Korea. 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?
Prediction accuracy of the thickness of rectus abdominis, biceps brachii muscles measured with point of care ultrasound (time frame: Preoperative evaluation). 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 22 Feb 2023.