Ultrasound to Evaluate the Quadriceps Muscle Wasting (ECHOSCAN)
Primary Purpose
Severe Cerebral Pathology
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CT Scan and ultrasonography
Sponsored by
About this trial
This is an interventional diagnostic trial for Severe Cerebral Pathology focused on measuring severe cerebral pathology, Ultrasound, thickness of the quadriceps
Eligibility 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).
Sites / Locations
- Chu Saint-Etienne
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CT scan and Ultrasonography
Arm Description
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 ) .
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
kinetic of the thickness of quadriceps
Evolution of he thickness of quadriceps measure concurrently by CT scan and Ultrasonography
Full Information
NCT ID
NCT02562495
First Posted
September 28, 2015
Last Updated
September 4, 2017
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
1. Study Identification
Unique Protocol Identification Number
NCT02562495
Brief Title
Ultrasound to Evaluate the Quadriceps Muscle Wasting
Acronym
ECHOSCAN
Official Title
Interest of the Ultrasound to Evaluate the Quadriceps Muscle Wasting in Critical Ill Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 21, 2016 (Actual)
Primary Completion Date
August 31, 2017 (Actual)
Study Completion Date
August 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Cerebral Pathology
Keywords
severe cerebral pathology, Ultrasound, thickness of the quadriceps
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CT scan and Ultrasonography
Arm Type
Experimental
Arm Description
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 ) .
Intervention Type
Device
Intervention Name(s)
CT Scan and ultrasonography
Intervention Description
Up to three measurements (CT scan and Ultrasonography) of the thickness of quadriceps, will be made concurrently .
Primary Outcome Measure Information:
Title
Concordance of the measurement of the quadriceps thickness by ultrasound and by CT scan
Description
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 Outcome Measure Information:
Title
kinetic of the thickness of quadriceps
Description
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 )
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jérôme MOREL, MD
Organizational Affiliation
CHU SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Saint-Etienne
City
Saint-etienne
ZIP/Postal Code
42055
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ultrasound to Evaluate the Quadriceps Muscle Wasting
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