Clinical trial NCT05108441: Ultrasound and MRI Measurement of Quadriceps Femoris Muscle in Critically Ill Children
Official title: Comparison of Quadriceps Femoris Measurements in Critically Ill Children, Using Bedside Ultrasound and Magnetic Resonance Imaging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-11-05
Enrollment: 35
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: intraclass correlation coefficient between ultrasound measurements and magnetic resonance imaging measurements
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Paediatric intensive care - Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: VALLA Frédéric, Pr
role: PRINCIPAL_INVESTIGATOR
References: