Ultrasound to Evaluate the Quadriceps Muscle Wasting

Not Applicable

Completed

• Conditions: Severe Cerebral Pathology
• Interventions: Device: CT Scan and ultrasonography

• Registration Number: NCT02562495
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2015-09-28
• Study First Submitted QC: 2015-09-28
• Study First Posted: 2015-09-29
• Study Start: 2016-01-21
• Primary Completion: 2017-08-31
• Study Completion: 2017-08-31
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-04
• Last Update Posted: 2017-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CT scan and Ultrasonography	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 ) .

Primary Outcome Measures

Name	Time	Method
Concordance of the measurement of the quadriceps thickness by ultrasound and by CT scan	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

Name	Time	Method
kinetic of the thickness of quadriceps	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

Trial Locations

Locations (1)

Chu Saint-Etienne; 🇫🇷 Saint-etienne, France