Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-02-21 @ 4:09 AM
Study NCT ID:
NCT02562495
Status:
COMPLETED
Last Update Posted:
2017-09-06
First Post:
2015-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound to Evaluate the Quadriceps Muscle Wasting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}, {'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D014054', 'term': 'Tomography'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-04', 'studyFirstSubmitDate': '2015-09-28', 'studyFirstSubmitQcDate': '2015-09-28', 'lastUpdatePostDateStruct': {'date': '2017-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concordance of the measurement of the quadriceps thickness by ultrasound and by CT scan', 'timeFrame': 'Between the day of admission (D1) in intensive care unit and the tenth day ( D10 )', 'description': 'Concordance of each of the three measurements of the thickness of quadriceps realised concurrently by CT scan and Ultrasonography (composite measure)'}], 'secondaryOutcomes': [{'measure': 'kinetic of the thickness of quadriceps', 'timeFrame': 'Between the day of admission (D1) in intensive care unit and the tenth day ( D10 )', 'description': 'Evolution of he thickness of quadriceps measure concurrently by CT scan and Ultrasonography'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['severe cerebral pathology', 'Ultrasound', 'thickness of the quadriceps'], 'conditions': ['Severe Cerebral Pathology']}, 'descriptionModule': {'briefSummary': '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.\n\nClinical 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.\n\nUltrasound (US) is an easy access tool at the bedside to assess muscle mass and does not expose the patient to additional radiation.\n\nThe objective of this study is to evaluate the correlation between US and CT scan to measure quadriceps muscle thickness of ICU patients.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n\nExclusion Criteria:\n\n* Pregnancy,\n* Bilateral trauma of thighs,\n* Coma induced by poisoning or by a metabolic disorder,\n* Morbid obesity (BMI \\> 35).'}, 'identificationModule': {'nctId': 'NCT02562495', 'acronym': 'ECHOSCAN', 'briefTitle': 'Ultrasound to Evaluate the Quadriceps Muscle Wasting', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Interest of the Ultrasound to Evaluate the Quadriceps Muscle Wasting in Critical Ill Patients.', 'orgStudyIdInfo': {'id': '1508123'}, 'secondaryIdInfos': [{'id': '2015-A01204-45', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CT scan and Ultrasonography', 'description': '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 ) .', 'interventionNames': ['Device: CT Scan and ultrasonography']}], 'interventions': [{'name': 'CT Scan and ultrasonography', 'type': 'DEVICE', 'description': 'Up to three measurements (CT scan and Ultrasonography) of the thickness of quadriceps, will be made concurrently .', 'armGroupLabels': ['CT scan and Ultrasonography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Chu Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Jérôme MOREL, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}