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Trials / Recruiting

RecruitingNCT05108441

Ultrasound and MRI Measurement of Quadriceps Femoris Muscle in Critically Ill Children

Comparison of Quadriceps Femoris Measurements in Critically Ill Children, Using Bedside Ultrasound and Magnetic Resonance Imaging

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
35 (estimated)
Sponsor
Hospices Civils de Lyon · Academic / Other
Sex
All
Age
1 Year – 17 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERUltrasound 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.

Timeline

Start date
2022-02-28
Primary completion
2026-04-30
Completion
2026-04-30
First posted
2021-11-05
Last updated
2025-08-22

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT05108441. Inclusion in this directory is not an endorsement.