Ultrasound to Evaluate the Quadriceps Muscle Wasting

NCT ID: NCT02562495

Last Updated: 2017-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-21

Study Completion Date

2017-08-31

Brief Summary

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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

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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.

Conditions

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Severe Cerebral Pathology

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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 ) .

Group Type EXPERIMENTAL

CT Scan and ultrasonography

Intervention Type DEVICE

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

Interventions

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CT Scan and ultrasonography

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

Intervention Type DEVICE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jérôme MOREL, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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Chu Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2015-A01204-45

Identifier Type: OTHER

Identifier Source: secondary_id

1508123

Identifier Type: -

Identifier Source: org_study_id

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