Quadriceps Femoris Measurement as a Surrogate of Muscle Mass Assessment in Critically Ill ChildrenEcho-QF-IRMNCT05108441
Ultrasound and MRI Measurement of Quadriceps Femoris Muscle in Critically Ill Children
A study testing Ultrasound and magnetic resonance imaging measurements of quadriceps femoris in people with Quadriceps Femoris Measurement as a Surrogate of Muscle Mass Assessment in Critically Ill Children, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
A vast majority of children admitted to paediatric intensive care (PICU) present with faltering growth during their admission. Muscle mass loss is an early, intense and frequent phenomenon in this setting, which is associated with impaired outcomes. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Quadriceps Femoris Measurement as a Surrogate of Muscle Mass Assessment in Critically Ill Children
- What is being tested?
- Ultrasound and magnetic resonance imaging measurements of quadriceps femoris
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 28 Feb 2022to 5 Feb 2026
- Phase
- Interventional
- 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 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- critically ill children from 0 to 17 years old
- magnetic resonance imaging planned for any medical reason
- sedated child for any medical reason
- absence of parental/patient refusal to participate to the study
Who cannot join
- congenital neuromuscular disease
- no possible access to the thigh (e.g. dressing, drains, gypsum)
- anatomical anomaly of the limb, that would compromise localizing thigh landmarks (patella, groin)
- inability to obtain limb rest and/or thigh muscle decontraction
- risk induced by mobilization of the patient for ultrasound or magnetic resonance imaging purpose
- absence of social insurance
Trial locations and contacts
1 site in 1 country.
France1 site
Paediatric intensive care - Hospices Civils de Lyon
Bron, Bron, 69500
About this study
Official title: Comparison of Quadriceps Femoris Measurements in Critically Ill Children, Using Bedside Ultrasound and Magnetic Resonance Imaging
A vast majority of children admitted to paediatric intensive care (PICU) present with faltering growth during their admission. Muscle mass loss is an early, intense and frequent phenomenon in this setting, which is associated with impaired outcomes. Recent international guidelines recommend monitoring both nutritional status and muscle mass throughout hospital stay. Recent studies have used quadriceps femoris (QF) measurements as a surrogate for lean mass assessment, and monitored them with bedside ultrasound (QF thickness and QF cross sectional area). However, ultrasound cross sectional area inter-operator reproducibility has not been validated so far, and none of these ultrasound measurements has been validated against their gold standard i.e. magnetic resonance imaging measurements. This validation process should be conducted to allow interpreting ultrasound muscle measurements, prior to the implementation of ultrasound measurments into clinical practice.
We hypothesise that ultrasound measurements of QF thickness and cross sectional area are reliable compared to the magnetic resonance imaging gold standard, and that QF cross sectional area has a reliable inter-operator reproducibility.
- Conditions
- Quadriceps Femoris Measurement as a Surrogate of Muscle Mass Assessment in Critically Ill Children
- Being tested
- Ultrasound and magnetic resonance imaging measurements of quadriceps femoris
- Keywords
- Ultrasound;, Magnetic resonance imaging;, quadriceps femoris,, critically ill children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound and magnetic resonance imaging measurements of quadriceps femorisOther
In sedated critically ill children, quadriceps femoris thickness and cross sectional area will be measured with thigh bedside ultrasound, performed by two trained operators consecutively. These two measurements will also be made at the exact same location on a magnetic resonance imaging transverse view of the thigh, to allow comparing them to ultrasound measurements.
| Study group | Role | What they receive |
|---|---|---|
| Echo | Other | Ultrasound and magnetic resonance imaging measurements of quadriceps femoris Receives: Other: Ultrasound and magnetic resonance imaging measurements of quadriceps femoris |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraclass correlation coefficient between ultrasound measurements and magnetic resonance imaging measurements
The mean of 4 measurements of quadriceps femoris thickness and the mean of 3 measurements of quadriceps femoris cross sectional area, performed by ultrasound, will be compared with the measurements means performed by magnetic resonance imaging
Measured: All ultrasound measurements will be made the same day than the magnetic resonance imaging, in a 6 hour-range prior or after the magnetic resonance imaging.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start28 Feb 2022
- Primary completion5 Feb 2026
- Study completion5 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quadriceps Femoris Measurement as a Surrogate of Muscle Mass Assessment in Critically Ill ChildrenStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- VALLA Frédéric, Pr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108441
- Sponsor's protocol ID
- 69HCL21_1076
- Acronym
- Echo-QF-IRM
- Status last verified
- May 2026
- First submitted
- 25 Oct 2021
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Quadriceps Femoris Measurements in Critically Ill Children, Using Bedside Ultrasound and Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT05108441
- Acronym / sponsor ID
- Echo-QF-IRM / 69HCL21_1076
- Conditions
- Quadriceps Femoris Measurement as a Surrogate of Muscle Mass Assessment in Critically Ill Children
- Keywords
- Ultrasound;, Magnetic resonance imaging;, quadriceps femoris,, critically ill children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 5 Feb 2026 (actual)
- Study completion
- 5 Feb 2026 (actual)
- First posted
- 5 Nov 2021 (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.
A vast majority of children admitted to paediatric intensive care (PICU) present with faltering growth during their admission. Muscle mass loss is an early, intense and frequent phenomenon in this setting, which is associated with impaired outcomes. Recent international guidelines recommend monitoring both nutritional status and muscle mass throughout hospital stay. Recent studies have used quadriceps femoris (QF) measurements as a surrogate for lean mass assessment, and monitored them with bedside ultrasound (QF thickness and QF cross sectional area). However, ultrasound cross sectional area inter-operator reproducibility has not been validated so far, and none of these ultrasound measurements has been validated against their gold standard i.e. magnetic resonance imaging measurements. This validation process should be conducted to allow interpreting ultrasound muscle measurements, prior to the implementation of ultrasound measurments into clinical practice.
We hypothesise that ultrasound measurements of QF thickness and cross sectional area are reliable compared to the magnetic resonance imaging gold standard, and that QF cross sectional area has a reliable inter-operator reproducibility.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Echo | Other | Other: Ultrasound and magnetic resonance imaging measurements of quadriceps femorisUltrasound and magnetic resonance imaging measurements of quadriceps femoris |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- critically ill children from 0 to 17 years old
- magnetic resonance imaging planned for any medical reason
- sedated child for any medical reason
- absence of parental/patient refusal to participate to the study
Key exclusion criteria (6 listed)
- congenital neuromuscular disease
- no possible access to the thigh (e.g. dressing, drains, gypsum)
- anatomical anomaly of the limb, that would compromise localizing thigh landmarks (patella, groin)
- inability to obtain limb rest and/or thigh muscle decontraction
- risk induced by mobilization of the patient for ultrasound or magnetic resonance imaging purpose
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 |
|---|---|---|
| Ultrasound and magnetic resonance imaging measurements of quadriceps femorisIn sedated critically ill children, quadriceps femoris thickness and cross sectional area will be measured with thigh bedside ultrasound, performed by two trained operators consecutively. These two measurements will also be made at the exact same location on a magnetic resonance imaging transverse view of the thigh, to allow comparing them to ultrasound measurements. | Other | Echo |
Primary outcome
intraclass correlation coefficient between ultrasound measurements and magnetic resonance imaging measurements
Time frame: All ultrasound measurements will be made the same day than the magnetic resonance imaging, in a 6 hour-range prior or after the magnetic resonance imaging.
The mean of 4 measurements of quadriceps femoris thickness and the mean of 3 measurements of quadriceps femoris cross sectional area, performed by ultrasound, will be compared with the measurements means performed by magnetic resonance imaging
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 11 May 2026.
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.
VALLA Frédéric, Pr principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound and magnetic resonance imaging measurements of quadriceps femoris in people with Quadriceps Femoris Measurement as a Surrogate of Muscle Mass Assessment in Critically Ill Children, run by Hospices Civils de Lyon 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 4 inclusion and 6 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 11 May 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?
intraclass correlation coefficient between ultrasound measurements and magnetic resonance imaging measurements (time frame: All ultrasound measurements will be made the same day than the magnetic resonance imaging, in a 6 hour-range prior or after the magnetic resonance imaging.). 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 11 May 2026.