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Ultrasound to Evaluate the Quadriceps Muscle Wasting (ECHOSCAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02562495
Recruitment Status : Completed
First Posted : September 29, 2015
Last Update Posted : September 6, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Brief 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.


Condition or disease Intervention/treatment Phase
Severe Cerebral Pathology Device: CT Scan and ultrasonography Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Interest of the Ultrasound to Evaluate the Quadriceps Muscle Wasting in Critical Ill Patients.
Actual Study Start Date : January 21, 2016
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Concordance of the measurement of the quadriceps thickness by ultrasound and by CT scan [ Time Frame: Between the day of admission (D1) in intensive care unit and the tenth day ( D10 ) ]
    Concordance of each of the three measurements of the thickness of quadriceps realised concurrently by CT scan and Ultrasonography (composite measure)


Secondary Outcome Measures :
  1. kinetic of the thickness of quadriceps [ Time Frame: Between the day of admission (D1) in intensive care unit and the tenth day ( D10 ) ]
    Evolution of he thickness of quadriceps measure concurrently by CT scan and Ultrasonography



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562495


Locations
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France
Chu Saint-Etienne
Saint-etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Jérôme MOREL, MD CHU SAINT-ETIENNE
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02562495    
Other Study ID Numbers: 1508123
2015-A01204-45 ( Other Identifier: ANSM )
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
severe cerebral pathology
Ultrasound
thickness of the quadriceps
Additional relevant MeSH terms:
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Muscular Atrophy
Signs and Symptoms
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical