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Clinical Trials/NCT02562495
NCT02562495CompletedNot Applicable

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

Centre Hospitalier Universitaire de Saint Etienne1 site in 1 country42 target enrollmentStarted: January 21, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
42
Locations
1
Primary Endpoint
Concordance of the measurement of the quadriceps thickness by ultrasound and by CT scan

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
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

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

Arms & Interventions

CT scan and Ultrasonography

Experimental

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: CT Scan and ultrasonography (Device)

Outcomes

Primary Outcomes

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 Outcomes

  • kinetic of the thickness of quadriceps(Between the day of admission (D1) in intensive care unit and the tenth day ( D10 ))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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