Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT03352102
Status:
COMPLETED
Last Update Posted:
2017-12-05
First Post:
2017-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Electrical Stimulation of the Quadriceps and Diaphragm in Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004558', 'term': 'Electric Stimulation'}], 'ancestors': [{'id': 'D010812', 'term': 'Physical Stimulation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-03', 'studyFirstSubmitDate': '2017-11-20', 'studyFirstSubmitQcDate': '2017-11-20', 'lastUpdatePostDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ICU and Hospital length of stay', 'timeFrame': '60 days', 'description': 'Length of stay (in days) in ICU and in hospitalization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Electric Stimulation', 'Intensive Care Units', 'Mechanical Ventilation', 'Ventilator Weaning'], 'conditions': ['Critical Illness Myopathy', 'Respiration, Artificial']}, 'descriptionModule': {'briefSummary': 'Subjects in MV will be included, divided into 3 groups: (a) Control Group (CG), (b) Stimulation of Quadriceps (Quadriceps Group - QG), (c) Stimulation of Diaphragm (Diaphragm Group - DG). The QG and DG patients will receive consecutive daily electrical stimulation sessions at specific points from the first day of randomization until ICU discharge. Respiratory and peripheral muscle strength, MV time, length of hospitalization and functional independence score (the Functional Status Score-ICU) will be recorded.', 'detailedDescription': 'Objective: Evaluate the effectiveness of the Neuro Muscular Electrical Stimulation therapy in quadriceps versus diaphragm subjects on mechanical ventilation (MV). Subjects in MV will be included, divided into 3 groups: (a) Control Group (CG), (b) Stimulation of Quadriceps (Quadriceps Group - QG), (c) Stimulation of Diaphragm (Diaphragm Group - DG). The QG and DG patients will receive consecutive daily electrical stimulation sessions at specific points from the first day of randomization until ICU discharge. Respiratory and peripheral muscle strength, MV time, length of hospitalization and functional independence score (the Functional Status Score-ICU) will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age of 18 years or more\n* 24 hours of MV or more\n\nExclusion Criteria:\n\nHemodynamic instability, pregnancy, body mass index(BMI) \\>35 kg/m2, history of neuromuscular disease at admission, brain death, diseases with systemic vascular involvement, bone fractures, use of an internal or external fixator, skin lesions, end-stage cancer, use of pacemakers, spinal injuries, or inability to receive an Medical Research Council score because of the cognitive state.'}, 'identificationModule': {'nctId': 'NCT03352102', 'briefTitle': 'Electrical Stimulation of the Quadriceps and Diaphragm in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Estadual do Oeste do Paraná'}, 'officialTitle': 'Effects of Neuromuscular Electrical Stimulation of the Quadriceps and Diaphragm in Critically Ill Patients: a Pilot Study.', 'orgStudyIdInfo': {'id': '134673'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diaphragm Group (DG)', 'description': 'subjects who received conventional physical therapy once a day, plus a daily session of electrical stimulation in the diaphragm.\n\nIntervention: Electrical stimulation of the diaphragm.', 'interventionNames': ['Procedure: Electrical stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Quadriceps Group (QG)', 'description': 'subjects who also received conventional physical therapy once a day, plus a daily session of electrical stimulation in the quadriceps.\n\nIntervention: Electrical stimulation of the quadriceps.', 'interventionNames': ['Procedure: Electrical stimulation']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group (CG)', 'description': 'subjects who received regular treatment, i.e., conventional physical therapy, which included gross motor therapy and respiratory therapy twice a day every day, including weekend, during their stay in the ICU.'}], 'interventions': [{'name': 'Electrical stimulation', 'type': 'PROCEDURE', 'description': 'Neuromuscular electrical stimulation therapy was performed', 'armGroupLabels': ['Diaphragm Group (DG)', 'Quadriceps Group (QG)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85806-470', 'city': 'Cascavel', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Hospital Universitário do Oeste do Paraná', 'geoPoint': {'lat': -24.95583, 'lon': -53.45528}}], 'overallOfficials': [{'name': 'Pericles Duarte', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitário do Oeste do Parana, Universidade Estadual do Oeste do Parana.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pericles Almeida Delfino Duarte', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Pericles Almeida Delfino Duarte', 'investigatorAffiliation': 'Universidade Estadual do Oeste do Paraná'}}}}