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

NCT ID: NCT05108441

Last Updated: 2025-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-28

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Quadriceps Femoris Measurement as a Surrogate of Muscle Mass Assessment in Critically Ill Children

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Echo

Ultrasound and magnetic resonance imaging measurements of quadriceps femoris

Group Type OTHER

Ultrasound and magnetic resonance imaging measurements of quadriceps femoris

Intervention Type 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.

Interventions

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Ultrasound and magnetic resonance imaging measurements of quadriceps femoris

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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VALLA Frédéric, Pr

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Paediatric intensive care - Hospices Civils de Lyon

Bron, Bron, France

Site Status RECRUITING

Countries

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France

Central Contacts

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VALLA Frédéric, Pr

Role: CONTACT

+33 472 12 97 44

BAUDIN Florent, Dr

Role: CONTACT

+33 472 12 97 35

Facility Contacts

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VALLA Frédéric, Pr

Role: primary

+33 472 12 97 44

BAUDIN Florent, Dr

Role: backup

+33 472 12 97 35

Other Identifiers

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69HCL21_1076

Identifier Type: -

Identifier Source: org_study_id

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