Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT06621693
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-01
First Post:
2024-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Neuromuscular Electrical Stimulation on Phrenic Nerve Regeneration Post Cardiac Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-29', 'studyFirstSubmitDate': '2024-09-29', 'studyFirstSubmitQcDate': '2024-09-29', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phrenic nerve conduction study: motor latency', 'timeFrame': '4 weeks', 'description': 'Nihon Kohden Neuropak M1 MEB-9200 EMG machine, made in Japan will be used to measure phrenic nerve conduction study.\n\nMotor latency is the impulse traveled from the stimulation site to the recording site is called latency and it is measured in milliseconds (ms). its normal value: (5.74ms -7.10 ms).'}, {'measure': 'Phrenic nerve conduction study: Amplitude', 'timeFrame': '4 weeks', 'description': 'Nihon Kohden Neuropak M1 MEB-9200 EMG machine, made in Japan will be used to measure phrenic nerve conduction study.\n\nAmplitude represents the maximal action potential depolarization and voltage gradient for all depolarized fibers of the phrenic nerve. it is measured in microvolt or millivolt (mv). its normal value: (0.47 mv-0.83 mv).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post-cardiac Surgery']}, 'descriptionModule': {'briefSummary': 'This study will be conducted to investigate the effect of neuromuscular electrical stimulation on phrenic regeneration post cardiac surgery', 'detailedDescription': 'Phrenic nerve injury post cardiac surgery is a serious problem closely related to frequent respiratory complications. It has been associated with diaphragm dysfunction, pneumonia and difficulty weaning from mechanical ventilation in critical ill patients.\n\nNeuromuscular electrical stimulation (NMES) is commonly used in physical therapy to increase muscle strength and promote muscle hypertrophy.\n\nThere is increased flow of patients after heart surgery in kasr Aini hospital who suffers from respiratory complication due to phrenic nerve injury so the hospitalization period of them increased which make economic burden in health insurance services with decreased level of quality of life that is the most concern as to improve patient status and relief this burden. So this study aims to decrease respiratory complication and improve phrenic nerve regeneration by using neuromuscular electrical stimulation as a safe, noninvasive , inexpensive and virtually risk free method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients post cardiac surgery (coronary artery bypass graft, valve repair or replacement ).\n* Patients referred by physician.\n* Medically stable patients.\n* Both genders\n* Ages from 25 to 45\n* BMI 25-29.9 kg/m2\n* Able to understand the requirements of the study.\n* Conscious patient and respond to verbal commands.\n\nExclusion Criteria:\n\nParticipants will be excluded if they meet one of the following criteria:\n\n* Patients with rib fracture.\n* Patients developing lung cancer.\n* Patients have dementia.\n* Patients on mechanical ventilator after 24 hours\n* Metabolically unstable chronic illness'}, 'identificationModule': {'nctId': 'NCT06621693', 'briefTitle': 'Effect of Neuromuscular Electrical Stimulation on Phrenic Nerve Regeneration Post Cardiac Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Neuromuscular Electrical Stimulation on Phrenic Nerve Regeneration Post Cardiac Surgeries', 'orgStudyIdInfo': {'id': 'P.T.REC/012/005299'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcutaneous electrical diaphragmatic stimulation intervention and traditional physiotherapy group', 'description': 'This group will receive transcutaneous electrical diaphragmatic stimulation intervention and traditional physiotherapy three times per week for 4 weeks', 'interventionNames': ['Device: Transcutaneous electrical diaphragmatic stimulation intervention', 'Other: traditional physiotherapy program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional physiotherapy group', 'description': 'This group will receive traditional physiotherapy only, three times per week for 4 weeks', 'interventionNames': ['Other: traditional physiotherapy program']}], 'interventions': [{'name': 'Transcutaneous electrical diaphragmatic stimulation intervention', 'type': 'DEVICE', 'description': 'It will be applied on diaphragm, 30 min per session ,3 days/week for 4 weeks at a stimulation frequency of 30 Hz, pulse width of 400 μs, the intensity was gradually increased until visible muscle contraction was observed.', 'armGroupLabels': ['Transcutaneous electrical diaphragmatic stimulation intervention and traditional physiotherapy group']}, {'name': 'traditional physiotherapy program', 'type': 'OTHER', 'description': 'The participants will receive traditional physiotherapy ( postural drainage, percussion , diaphragmatic breathing, phase 1 cardiac Rehabilitation and balance training ) three times per week for 4 weeks', 'armGroupLabels': ['Traditional physiotherapy group', 'Transcutaneous electrical diaphragmatic stimulation intervention and traditional physiotherapy group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Hala Atef Abdel Fattah', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Hala A. Abdel Fattah, Master', 'role': 'CONTACT', 'email': 'hala.atef1996@gmail.com', 'phone': '+201027551192'}, {'name': 'Rana H. El Banaa, PHD', 'role': 'CONTACT', 'email': 'rana.elbanna@yahoo.com', 'phone': '+201062070686'}], 'overallOfficials': [{'name': 'Hala R. Mahmoud, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}, {'name': 'Nagwa M. Badr, professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Hala Atef Abd El Fatah', 'investigatorAffiliation': 'Cairo University'}}}}