Ultrasound and MRI Measurement of Quadriceps Femoris Muscle in Critically Ill Children (Echo-QF-IRM)

July 19, 2023 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Echo
Ultrasound and magnetic resonance imaging measurements of quadriceps femoris
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: VALLA Frédéric, Pr, Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2022

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

October 25, 2021

First Submitted That Met QC Criteria

October 25, 2021

First Posted (Actual)

November 5, 2021

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL21_1076

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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