Ultrasound to Evaluate the Quadriceps Muscle Wasting

Severe Cerebral Pathology Clinical Trial

— ECHOSCAN  

Official title:

Interest of the Ultrasound to Evaluate the Quadriceps Muscle Wasting in Critical Ill Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02562495
• Other study ID #: 1508123
• Secondary ID: 2015-A01204-45
• Status: Completed
• Phase: N/A
• First received: September 28, 2015
• Last updated: September 4, 2017
• Start date: January 21, 2016
• Est. completion date: August 31, 2017

Study information

• Verified date: September 2017
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 31, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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).

Related Conditions & MeSH terms

• Muscular Atrophy
• Severe Cerebral Pathology

Intervention

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

Locations

Country	Name	City	State
France	Chu Saint-Etienne	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Between the day of admission (D1) in intensive care unit and the tenth day ( D10 )
Secondary	kinetic of the thickness of quadriceps	Evolution of he thickness of quadriceps measure concurrently by CT scan and Ultrasonography	Between the day of admission (D1) in intensive care unit and the tenth day ( D10 )