Severe Cerebral PathologyECHOSCANNCT02562495
Ultrasound to Evaluate the Quadriceps Muscle Wasting
A study testing CT Scan and ultrasonography in people with Severe Cerebral Pathology, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Severe Cerebral Pathology
- What is being tested?
- CT Scan and ultrasonography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jan 2016to 31 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy,
- Bilateral trauma of thighs,
- Coma induced by poisoning or by a metabolic disorder,
- Morbid obesity (BMI > 35).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of the Ultrasound to Evaluate the Quadriceps Muscle Wasting in Critical Ill Patients.
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.
Read more
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.
Read the 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.
- Conditions
- Severe Cerebral Pathology
- Being tested
- CT Scan and ultrasonography
- Keywords
- severe cerebral pathology, Ultrasound, thickness of the quadriceps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT Scan and ultrasonographyDevice
Up to three measurements (CT scan and Ultrasonography) of the thickness of quadriceps, will be made concurrently .
| Study group | Role | What they receive |
|---|---|---|
| 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 ) . Receives: Device: CT Scan and ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Between the day of admission (D1) in intensive care unit and the tenth day ( D10 )
Secondary outcomes (1)
kinetic of the thickness of quadriceps
Evolution of he thickness of quadriceps measure concurrently by CT scan and Ultrasonography
Measured: Between the day of admission (D1) in intensive care unit and the tenth day ( D10 )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study start21 Jan 2016
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Cerebral PathologyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérôme MOREL, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562495
- Sponsor's protocol ID
- 1508123
- Other IDs
- 2015-A01204-45
- Acronym
- ECHOSCAN
- Status last verified
- Sep 2017
- First submitted
- 28 Sep 2015
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of the Ultrasound to Evaluate the Quadriceps Muscle Wasting in Critical Ill Patients.
- ClinicalTrials.gov ID
- NCT02562495
- Acronym / sponsor ID
- ECHOSCAN / 1508123
- Conditions
- Severe Cerebral Pathology
- Keywords
- severe cerebral pathology, Ultrasound, thickness of the quadriceps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 21 Jan 2016 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 29 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT scan and Ultrasonography | Experimental | Device: CT Scan and ultrasonographyUp 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 ) . |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnancy,
- Bilateral trauma of thighs,
- Coma induced by poisoning or by a metabolic disorder,
- Morbid obesity (BMI > 35).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT Scan and ultrasonographyUp to three measurements (CT scan and Ultrasonography) of the thickness of quadriceps, will be made concurrently . | Device | CT scan and Ultrasonography |
Primary outcome
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)
1 secondary outcome
kinetic of the thickness of quadriceps
Time frame: Between the day of admission (D1) in intensive care unit and the tenth day ( D10 )
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jérôme MOREL, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT Scan and ultrasonography in people with Severe Cerebral Pathology, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 )). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2017.