Completed

NCT Number: NCT02562495

Ultrasound to Evaluate the Quadriceps Muscle Wasting

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.

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Key information

Conditions

Severe Cerebral Pathology

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Saint-Etienne

Saint-Etienne, 42055, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

CT Scan and ultrasonography

Device

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

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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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

Acronym: ECHOSCAN

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Sep 29, 2015
Registry last updated: Sep 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.