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CompletedNCT02562495ECHOSCANUpdated Sep 6, 2017

Ultrasound to Evaluate the Quadriceps Muscle Wasting

An interventional study of CT Scan and ultrasonography in Severe Cerebral Pathology, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 1 site in France. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2017-09-06.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Not applicable
Ages
18 Years to 100 Years
Sex
All
01

Study summary

Intensive care unit acquired muscle weakness (ICUAW) is a common disease. After 7 days of mechanical ventilation, a quarter of patients develop an ICUAW responsible of a 15-20% of muscle loss. This is a serious pathology associated with high morbidity and mortality.

Clinical diagnosis of ICUAW is difficult and need a patient awoken. CT scan and Magnetic Resonance Imaging (MRI) are considered as "gold standards" to quantify and monitor changes in muscle mass. But these tools are not adapted to ICU patients.

Ultrasound (US) is an easy access tool at the bedside to assess muscle mass and does not expose the patient to additional radiation.

The objective of this study is to evaluate the correlation between US and CT scan to measure quadriceps muscle thickness of ICU patients.

Read the detailed description

As part of the monitoring of the neurological disease, brain CT scans are frequently performed. At the same time, an acquisition sequence centered on the quadriceps will follow the brain sequences. Up to three brain CT scans coupled with a quadriceps imaging will be performed between the day of admission and on the tenth day of hospitalization. An ultrasound of the quadriceps will be performed concomitantly. The thickness of the quadriceps is measured by an independent operator on CT and ultrasound images.

02

Conditions studied

  • Severe Cerebral Pathology

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Keywords

  • severe cerebral pathology
  • Ultrasound
  • thickness of the quadriceps
03

In context

Muscular Atrophy

494 studies on the registry are indexed under Muscular Atrophy; 94 are open to participants now.

This study's enrollment of 42 is above the median of 33 across 335 interventional studies indexed under Muscular Atrophy.

Browse Muscular Atrophy studies →

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient over 18 years admitted to intensive care for a severe brain injury (Glasgow \<8) and with a predictive duration of mechanical of at least 48hours

Exclusion criteria

Exclusion Criteria:

  • Pregnancy,
  • Bilateral trauma of thighs,
  • Coma induced by poisoning or by a metabolic disorder,
  • Morbid obesity (BMI > 35).
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    CT scan and Ultrasonography

    Up to three measurements (CT scan and Ultrasonography), will be made concurrently between the day of admission (D1) in intensive care unit and the tenth day ( D10 ) .

    Device: CT Scan and ultrasonography

Interventions

  • DeviceCT Scan and ultrasonography

    Up to three measurements (CT scan and Ultrasonography) of the thickness of quadriceps, will be made concurrently .

06

What researchers measure

Primary outcomes

  1. Concordance of the measurement of the quadriceps thickness by ultrasound and by CT scan

    Concordance of each of the three measurements of the thickness of quadriceps realised concurrently by CT scan and Ultrasonography (composite measure)

    Time frame: Between the day of admission (D1) in intensive care unit and the tenth day ( D10 )

Secondary outcomes

  1. kinetic of the thickness of quadriceps

    Evolution of he thickness of quadriceps measure concurrently by CT scan and Ultrasonography

    Time frame: Between the day of admission (D1) in intensive care unit and the tenth day ( D10 )

07

Study locations

1 site
  • Chu Saint-Etienne
    Saint-etienne, 42055, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02562495
Lead sponsor
Centre Hospitalier Universitaire de Saint Etienne
Responsible party
Sponsor
First posted
Sep 29, 2015
Start date
Jan 21, 2016
Primary completion
Aug 31, 2017
Completion
Aug 31, 2017
Last update
Sep 6, 2017

Study contacts

Jérôme MOREL, MD
principal investigator · CHU SAINT-ETIENNE

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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