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OpenTrials
Completed

NCT Number: NCT05108441

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

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.

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Key information

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Paediatric intensive care - Hospices Civils de Lyon

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound and magnetic resonance imaging measurements of quadriceps femoris

Other

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.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: Echo-QF-IRM

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Nov 5, 2021
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.