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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ultrasound and magnetic resonance imaging measurements of quadriceps femoris
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Quadriceps Femoris Measurement as a Surrogate of Muscle Mass Assessment in Critically Ill Children focused on measuring Ultrasound;, Magnetic resonance imaging;, quadriceps femoris,, critically ill children

Eligibility Criteria

1 Year - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Paediatric intensive care - Hospices Civils de LyonRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Echo

Arm Description

Ultrasound and magnetic resonance imaging measurements of quadriceps femoris

Outcomes

Primary Outcome Measures

intraclass correlation coefficient between ultrasound measurements and magnetic resonance imaging measurements
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

Secondary Outcome Measures

Full Information

First Posted
October 25, 2021
Last Updated
July 19, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT05108441
Brief Title
Ultrasound and MRI Measurement of Quadriceps Femoris Muscle in Critically Ill Children
Acronym
Echo-QF-IRM
Official Title
Comparison of Quadriceps Femoris Measurements in Critically Ill Children, Using Bedside Ultrasound and Magnetic Resonance Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2022 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quadriceps Femoris Measurement as a Surrogate of Muscle Mass Assessment in Critically Ill Children
Keywords
Ultrasound;, Magnetic resonance imaging;, quadriceps femoris,, critically ill children

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Echo
Arm Type
Other
Arm Description
Ultrasound and magnetic resonance imaging measurements of quadriceps femoris
Intervention Type
Other
Intervention Name(s)
Ultrasound and magnetic resonance imaging measurements of quadriceps femoris
Intervention Description
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 Outcome Measure Information:
Title
intraclass correlation coefficient between ultrasound measurements and magnetic resonance imaging measurements
Description
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
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
VALLA Frédéric, Pr
Phone
+33 472 12 97 44
Email
Frederic.valla@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
BAUDIN Florent, Dr
Phone
+33 472 12 97 35
Email
Florent.baudin@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
VALLA Frédéric, Pr
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Paediatric intensive care - Hospices Civils de Lyon
City
Bron
ZIP/Postal Code
69500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VALLA Frédéric, Pr
Phone
+33 472 12 97 44
Email
Frederic.valla@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
BAUDIN Florent, Dr
Phone
+33 472 12 97 35
Email
Florent.baudin@chu-lyon.fr

12. IPD Sharing Statement

Learn more about this trial

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

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