FrailtyQUADRI-REANCT06523348
Ultrasound of the Quadriceps Femoris Compared With the Clinical Frailty Scale
An observational study of Frailty and Intensive Care Unit Syndrome, run by University Hospital, Toulouse at 1 site in France.
Trial summary
This is a single-centre prospective diagnostic study. When a patient is admitted to the inclusion centre, the clinician responsible for the patient checks the inclusion and exclusion criteria. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty, Intensive Care Unit Syndrome
- What is being tested?
- quadricipital muscle ultrasound
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 5 Aug 2024to 11 Jun 2025
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Any patient aged 65 or over admitted to intensive care or the emergency department who meets the eligibility criteria
Who may be able to join
- patient aged 65 or over
- admitted to intensive care or the outpatient department for less than 24 hours
- with an abdominal CT scan less than 30 days prior to admission OR who are scheduled for an scheduled for a routine abdomino-pelvic CT scan within the first 24 hours of admission
Who cannot join
- Neuromuscular disease
- Lower limb amputation
- Paraplegia > 24 hours before admission
- Clearly infected, burnt or lacerated ultrasound site.
- Guardianship or curatorship
- Opposition of the patient or his/her trusted support person or relative
- Abdominal and pelvic CT scan not available in the previous month and not scheduled within the first 24 hours of treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound of the Quadriceps Femoris for the Diagnosis of Frailty in the Intensive Care Unit, Compared With the Clinical Frailty Scale (CFS)
This is a single-centre prospective diagnostic study. When a patient is admitted to the inclusion centre, the clinician responsible for the patient checks the inclusion and exclusion criteria. The no objection from the patient (or their trusted support person or, failing that, a close if the patient is unable to give consent) is sought.The CFS scale is completed and recorded by the clinician in the observation observation notebook.The clinician performs a quadricipital muscle ultrasound, specifically for research purposes, with no changes to the therapeutic and its results are recorded in the observation notebook.
observation notebook.At 3 months after inclusion, information was collected from the medical records to identify secondary endpoints.
Translated with DeepL.com (free version)
Read the detailed description
Fragility is defined as a decline in physical and mental capacities leading to increased vulnerability to pathologies. It is now accepted that frail patients have a higher morbidity and mortality rate than non-frail patients. In intensive care, the prevalence of frail patients reaches 30% of patients admitted. These patients have a higher rate of complications and mortality than non-fragile patients.Identifying frail patients is therefore a major challenge in the ICU, to enable the risk of short-term mortality to be stratification of the risk of mortality in the short, medium and long term, and to predict the risk of complications.There are a large number of tools for diagnosing frailty, but not all of them can be used or validated in the ICU (intensive care unit). The need for a tool that is robust, reliable, reproducible and quick to use means that the CFS (Clinical Frailty Scale) a good tool for screening for frailty, particularly in intensive care. It predicts mortality in intensive care and in hospital, regardless of age. However, it requires the cooperation of the patient or the patient's family, and relies on a subjective approach to the patient's state of health by the clinician. This is why, in recent years, new objective tools for diagnosing frailty have been developed, based in particular on anthropometric measurements. The scanographic cross-sectional area of the psoas muscle appears to correlate well with fragility scales in the literature and is an independent risk factor for mortality.
Ultrasound depth of the quadriceps muscle is an easy, rapid and objective measure of the patient's muscle reserves. In the preoperative situation, this measurement correlates with fragility scales and is a risk factor for postoperative morbidity.
We propose to evaluate the diagnostic performance of bilateral ultrasound depth of the quadriceps femoris in comparison with the CFS scale to differentiate frail and non-frail patients in the intensive care unit.
Knowing whether the patient is fragile or not, quickly and objectively, can help the doctor, among other things, to define a reasonable level of therapeutic commitment for the patient and his or her pathology.
to define a reasonable level of therapeutic commitment for the patient and his or her pathology.
- Conditions
- Frailty, Intensive Care Unit Syndrome
- Being tested
- quadricipital muscle ultrasound
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quadricipital muscle ultrasoundDiagnostic test
ultrasound depth measurement of the quadriceps muscle
What is being measured
The primary outcome is the main question the study is designed to answer.
Bilateral ultrasound depth of the quadriceps femoris muscle
Bilateral ultrasound depth of the quadriceps femoris muscle: The ultrasound consists of 3 measurements per side of the thickness of the rectus femoris muscle. The ultrasound loops will be recorded on an ultrasound machine (GE) after anonymisation.
The images will be analysed a posteriori by the principal investigator and the associate investigators, experts in ultrasound analysis of this muscle.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start5 Aug 2024
- Primary completion11 Jun 2025
- Study completion11 Jun 2025
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 University Hospital, ToulouseThe 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
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523348
- Sponsor's protocol ID
- RC31/24/0180
- Other IDs
- N° ID-RCB
- Acronym
- QUADRI-REA
- Status last verified
- Aug 2026
- First submitted
- 22 Jul 2024
- Last updated
- 31 Aug 2026
- 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 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound of the Quadriceps Femoris for the Diagnosis of Frailty in the Intensive Care Unit, Compared With the Clinical Frailty Scale (CFS)
- ClinicalTrials.gov ID
- NCT06523348
- Acronym / sponsor ID
- QUADRI-REA / RC31/24/0180
- Conditions
- Frailty, Intensive Care Unit Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 11 Jun 2025 (actual)
- Study completion
- 11 Jun 2025 (actual)
- First posted
- 26 Jul 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.
This is a single-centre prospective diagnostic study. When a patient is admitted to the inclusion centre, the clinician responsible for the patient checks the inclusion and exclusion criteria. The no objection from the patient (or their trusted support person or, failing that, a close if the patient is unable to give consent) is sought.The CFS scale is completed and recorded by the clinician in the observation observation notebook.The clinician performs a quadricipital muscle ultrasound, specifically for research purposes, with no changes to the therapeutic and its results are recorded in the observation notebook.
observation notebook.At 3 months after inclusion, information was collected from the medical records to identify secondary endpoints.
Translated with DeepL.com (free version)
Detailed description
Fragility is defined as a decline in physical and mental capacities leading to increased vulnerability to pathologies. It is now accepted that frail patients have a higher morbidity and mortality rate than non-frail patients. In intensive care, the prevalence of frail patients reaches 30% of patients admitted. These patients have a higher rate of complications and mortality than non-fragile patients.Identifying frail patients is therefore a major challenge in the ICU, to enable the risk of short-term mortality to be stratification of the risk of mortality in the short, medium and long term, and to predict the risk of complications.There are a large number of tools for diagnosing frailty, but not all of them can be used or validated in the ICU (intensive care unit). The need for a tool that is robust, reliable, reproducible and quick to use means that the CFS (Clinical Frailty Scale) a good tool for screening for frailty, particularly in intensive care. It predicts mortality in intensive care and in hospital, regardless of age. However, it requires the cooperation of the patient or the patient's family, and relies on a subjective approach to the patient's state of health by the clinician. This is why, in recent years, new objective tools for diagnosing frailty have been developed, based in particular on anthropometric measurements. The scanographic cross-sectional area of the psoas muscle appears to correlate well with fragility scales in the literature and is an independent risk factor for mortality.
Ultrasound depth of the quadriceps muscle is an easy, rapid and objective measure of the patient's muscle reserves. In the preoperative situation, this measurement correlates with fragility scales and is a risk factor for postoperative morbidity.
We propose to evaluate the diagnostic performance of bilateral ultrasound depth of the quadriceps femoris in comparison with the CFS scale to differentiate frail and non-frail patients in the intensive care unit.
Knowing whether the patient is fragile or not, quickly and objectively, can help the doctor, among other things, to define a reasonable level of therapeutic commitment for the patient and his or her pathology.
to define a reasonable level of therapeutic commitment for the patient and his or her pathology.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Any patient aged 65 or over admitted to intensive care or the emergency department who meets the eligibility criteria
Key inclusion criteria (3 listed)
- patient aged 65 or over
- admitted to intensive care or the outpatient department for less than 24 hours
- with an abdominal CT scan less than 30 days prior to admission OR who are scheduled for an scheduled for a routine abdomino-pelvic CT scan within the first 24 hours of admission
Key exclusion criteria (7 listed)
- Neuromuscular disease
- Lower limb amputation
- Paraplegia > 24 hours before admission
- Clearly infected, burnt or lacerated ultrasound site.
- Guardianship or curatorship
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 |
|---|---|---|
| quadricipital muscle ultrasoundultrasound depth measurement of the quadriceps muscle | Diagnostic test | – |
Primary outcome
Bilateral ultrasound depth of the quadriceps femoris muscle
Time frame: 24 hours
Bilateral ultrasound depth of the quadriceps femoris muscle: The ultrasound consists of 3 measurements per side of the thickness of the rectus femoris muscle. The ultrasound loops will be recorded on an ultrasound machine (GE) after anonymisation. The images will be analysed a posteriori by the principal investigator and the associate investigators, experts in ultrasound analysis of this muscle.
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 31 Aug 2026.
- 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.
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 and Intensive Care Unit Syndrome, run by University Hospital, Toulouse at 1 site in France.
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 3 inclusion and 7 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 31 Aug 2026. 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 France. 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?
Bilateral ultrasound depth of the quadriceps femoris muscle (time frame: 24 hours). 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 31 Aug 2026.