Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-28 @ 9:18 PM
Study NCT ID:
NCT06135857
Status:
UNKNOWN
Last Update Posted:
2023-11-18
First Post:
2023-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electromuscular Stimulation Therapy as a Prophylactic Method to Reduce Thromboses Related to PICC Catheters in Patients Hospitalized in Critical Care Units.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-13', 'studyFirstSubmitDate': '2023-11-06', 'studyFirstSubmitQcDate': '2023-11-13', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To know the effectiveness of electromuscular stimulation therapy in patients hospitalized in critical care units to prevent venous thrombosis related to PICC catheters.', 'timeFrame': '15 days', 'description': 'Ultrasound will be used to measure whether or not there is the appearance of thrombosis related to the PICC catheter.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thrombosis; Catheter, Infusion Catheter (Vascular)']}, 'descriptionModule': {'briefSummary': 'Introduction: The placement of a peripheral inserted central catheter (PICC) is a common practice in the hospital setting. However, despite all the advances reported, venous devices are not free of complications and catheter-related thrombosis (CRT), being one of the most prevalent. Electro muscular stimulation therapy can be a measure for the prevention of CRT. Objective: To know the efficacy of electro muscular stimulation therapy in patients hospitalized in critical care units to prevent venous thrombosis related to PICC catheters. Methodology: A multicenter Randomized Clinical Trial (RCT) will be carried out at the Dr. Josep Trueta University Hospital in Girona, Hospital del Mar in Barcelona, Althaia Foundation in Manresa. With a total of 68 patients with PICC catheters in critical care units, they will be randomly assigned to the intervention group (n=34) to whom, in addition to the usual protocolized care related to the vascular catheter, will be applied e Eco-EMS protocol, or the control group (n=34) to which only the usual protocolized care related to the vascular catheter was applied. Intervention: It will consist of the application of electrostimulation therapy five days a week, two daily sessions of 20 minutes in the intervention group. Both groups underwent five ultrasound examinations after the placement of the PICC to determine the appearance of CRT. Expected results: It is expected to observe that the application of the Eco-EMS protocol reduces thrombosis in the patients of the intervention group, compared to those of the control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted to the critical unit with a PICC whose insertion is done by the EIAV of the same hospital.\n* Patients between 18 and 80 years of age.\n* Treatments related to the device protocolized by the same hospital as the EIAV implanter.\n\nExclusion Criteria:\n\n* Patients who do not sign informed consent.\n* Patients with pacemakers and/or implantable automatic defibrillators.\n* Patients with epilepsy.\n* Removal of the device within the first 15 days after insertion.\n* Hospital discharge, transfer to another hospital or death lethalis during the duration of the study.\n* Displacement of the tip of the catheter outside the lower ⅓ of the superior vein cava during the study period.\n* Presence of lesions in the place where the electrodes must be placed to perform the electrostimulation therapy.\n* Non-compliance with catheter monitoring: Of the five ultrasound controls protocolized in the study, 80% were not complied with.'}, 'identificationModule': {'nctId': 'NCT06135857', 'acronym': 'ECOEMS', 'briefTitle': 'Electromuscular Stimulation Therapy as a Prophylactic Method to Reduce Thromboses Related to PICC Catheters in Patients Hospitalized in Critical Care Units.', 'organization': {'class': 'OTHER', 'fullName': "Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta"}, 'officialTitle': 'Electromuscular Stimulation Therapy as a Prophylactic Method to Reduce Thromboses Related to PICC Catheters in Patients Hospitalized in Critical Care Units. Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': '2023.151'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'interventionNames': ['Device: Protocol ECOEMS']}, {'type': 'NO_INTERVENTION', 'label': 'Control group'}], 'interventions': [{'name': 'Protocol ECOEMS', 'type': 'DEVICE', 'description': 'Use electo estimulation therapy. The 4-channel stimulator will be used. The 6 electrodes will be located on the biceps, triceps and deltoids. Two daily sessions will be distributed, five days a week, lasting 20 minutes, the vascular program designed by the electro stimulation team itself will be applied.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ines Gerez Acevedo', 'role': 'CONTACT', 'email': 'ines04081994@gmail.com', 'phone': '636543624'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gerez Acevedo', 'investigatorAffiliation': "Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta"}}}}