Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT04852133
Status:
COMPLETED
Last Update Posted:
2021-10-19
First Post:
2021-04-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility and Reliability of Ultrasound in Acute Burns.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-11', 'studyFirstSubmitDate': '2021-04-15', 'studyFirstSubmitQcDate': '2021-04-15', 'lastUpdatePostDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reliability', 'timeFrame': '<72 hours of admission', 'description': 'Interrater reliability of QMLT and RF-CSA assessed by intraclass correlation'}], 'secondaryOutcomes': [{'measure': 'Feasibility of measurements', 'timeFrame': '<72 hours of admission', 'description': 'Feasibility of different techniques and locations of measurements, assessed by number of realised vs attempted measurements'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Burns', 'Ultrasound', 'Muscle wasting', 'Muscular Atrophy', 'Reliability', 'Feasibility'], 'conditions': ['Burns']}, 'descriptionModule': {'briefSummary': 'This trial investigates the feasibility and reliability of different ultrasound protocols to determine quadriceps muscle architecture in acutely admitted burn patients. The results of this trial will provide more clarity as to whether ultrasound can be used as a bedside tool to monitor muscle wasting.', 'detailedDescription': 'BACKGROUND Despite the ubiquity of muscle wasting following burns, practical and accurate tools to measure the degree of muscle wasting are lacking in burn care. Ultrasound has been used for this purpose in the critically-ill population and has shown to be valid and reliable. Whether this can be extrapolated to the burn population, however, remains unclear. Open wounds, fluid status, and uncertainty regarding which protocol to use are amongst factors that complicate the use of ultrasound during the acute phase of burns.\n\nAIM This study examines the reliability and feasibility of ultrasound measures in the acute burn setting comparing different techniques and locations of application.\n\nMETHODS Burned adults were assessed at admission in two Belgian burn centers by two trained assessors using B-mode ultrasound with a linear transducer. Ultrasound-derived variables included quadriceps muscle layer thickness (QMLT) and rectus femoris cross-sectional area (RF-CSA) on both thighs. Both maximum and minimum compression techniques were used for QMLT, while RF-CSA was determined by minimum compression only. QMLT was measured at a proximal and distal location on the thigh, and RF-CSA was measured at the most proximal location possible where the entire muscle belly still remained visible.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Burn subjects will be recruited from two specialised burn services in Belgium on a consecutive sampling basis during recruitment of a larger trial investigating the effects of exercise in the acute phase of burns \\[NCT04511104\\].\n\nHealthy subjects will be recruited by convenience sampling at the M2Run Metabolic Research Unit of the Department of Rehabilitation Sciences and Physiotherapy at the University of Antwerp.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Burn subjects:\n\nInclusion Criteria:\n\n* ≥10 - ≤80 %TBSA\n* Burn depth: 2nd deep / 3rd degree\n\nExclusion Criteria:\n\n* Electrical burn (except flash burns)\n* Associated injury: fracture lower limb\n* Diabetes Mellitus type 1\n* Central / peripheral neurological/neuromuscular disorders (interfering with exercise)\n* Cognitive / psychological disorders (interfering with cooperation)\n* Cardiopulmonary disease (interfering with exercise safety)\n* Pregnancy\n* Palliative care\n\nHealthy subjects:\n\n* none'}, 'identificationModule': {'nctId': 'NCT04852133', 'briefTitle': 'Feasibility and Reliability of Ultrasound in Acute Burns.', 'organization': {'class': 'OTHER', 'fullName': 'Universiteit Antwerpen'}, 'officialTitle': 'Feasibility and Reliability of Ultrasound Assessment of Muscle Architecture in Acute Burns.', 'orgStudyIdInfo': {'id': '11B8619N[US]'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Burn subjects', 'description': 'exposure to burn injury', 'interventionNames': ['Other: Burn subjects']}, {'label': 'Non-burned control', 'description': 'no exposure to burn injury'}], 'interventions': [{'name': 'Burn subjects', 'type': 'OTHER', 'description': 'see eligibility criteria', 'armGroupLabels': ['Burn subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2060', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Ziekenhuis Netwerk Antwerpen Stuivenberg', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '1120', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Militaire Hospitaal Koningin Astrid, Neder-Over-Heembeek', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Ulrike Van Daele, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Antwerp, Faculty of Medicine and Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Datasets will be made available upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiteit Antwerpen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Research Foundation Flanders', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor', 'investigatorFullName': 'Ulrike Van Daele', 'investigatorAffiliation': 'Universiteit Antwerpen'}}}}