Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-29 @ 4:08 AM
Study NCT ID:
NCT07133932
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-21
First Post:
2025-07-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phrenic Nerve Stimulation for Reducing Ventilation Duration in Acute Cerebral Infarction: A Multicenter Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002544', 'term': 'Cerebral Infarction'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D020520', 'term': 'Brain Infarction'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 590}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2025-07-21', 'studyFirstSubmitQcDate': '2025-08-13', 'lastUpdatePostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Tracheostomy rate', 'timeFrame': 'Through ICU discharge, up to 90 days'}, {'measure': 'In-hospital mortality', 'timeFrame': 'Through ICU discharge, up to 90 days'}, {'measure': 'Mortality at 90 days', 'timeFrame': '90 days of symptom onset'}, {'measure': 'ICU length of stay', 'timeFrame': 'Through ICU discharge, up to 90 days'}, {'measure': 'ICU cost', 'timeFrame': 'Through ICU discharge, up to 90 days'}, {'measure': 'Quality of Life (EQ-5D-5L score) at 90 days', 'timeFrame': '90 days of symptom onset'}, {'measure': 'Incidence rate of ventilator-associated pneumonia', 'timeFrame': 'Through ICU discharge, up to 90 days'}, {'measure': 'Incidence rate of ventilator-induced diaphragmatic dysfunction', 'timeFrame': 'Through ICU discharge, up to 90 days'}, {'measure': 'Number of participants with electrode patch-associated skin injury', 'timeFrame': 'Day 14'}], 'primaryOutcomes': [{'measure': 'Mechanical ventilation duration', 'timeFrame': 'Successfully weaned from ventilater for 48 hours', 'description': 'The total duration of mechanical ventilation, which is the time difference between starting mechanical ventilation and successfully weaning.'}], 'secondaryOutcomes': [{'measure': 'Successful weaning rate', 'timeFrame': 'Successfully weaned from ventilater for 48 hours'}, {'measure': 'mRS at 90 days', 'timeFrame': '90 days of symptom onset'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Infarction', 'Mechanical Ventilation', 'Acute Cerebrovascular Accident', 'Adult']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if non-invasive phrenic nerve stimulation works in adult acute cerebral infarction participants undergoing mechanical ventilation. It will also learn about the safety of non-invasive phrenic nerve stimulation. The main questions it aims to answer are：\n\n1. Can non-invasive phrenic nerve stimulation shorten the duration of ventilator use and improve long-term prognosis?\n2. What medical problems do participants have when taking non-invasive phrenic nerve stimulation? Researchers will compare non-invasive phrenic nerve stimulation to a sham stimulation to see if non-invasive phrenic nerve stimulation works.\n\nParticipants will:\n\n1. Receive 14 days of non-invasive phrenic nerve stimulation or sham stimulation\n2. Visit the clinic or call for follow-up at 90 days of onset'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥ 18 years old\n* no gender restrictions\n* patient diagnosed with acute cerebral infarction (within 30 days of onset) through cranial CT or MRI\n* duration of mechanical ventilation ≥ 24 hours\n* patient or their legal guardian agrees to participate in the study and signs an informed consent form\n\nExclusion Criteria:\n\n* there are other significant conditions that affect diaphragm function, such as severe malnutrition, irreversible respiratory pump failure caused by medullary or cervical cord injury, and irreversible damage to the phrenic nerve\n* significant agitation cannot be combined with transcutaneous electrical phrenic nerve stimulation\n* severe skin damage or infection at the electrode placement site\n* previous presence of severe lung disease (such as severe COPD, interstitial lung disease, pulmonary embolism, etc.), severe heart failure (NYHA Class IV)\n* sepsis or shock requiring high-dose vasopressors\n* the terminal state of the disease or expected survival period does not exceed 7 days\n* pacemaker implantation\n* pregnant or lactating women\n* patients whose family members express their willingness to withdraw for treatment'}, 'identificationModule': {'nctId': 'NCT07133932', 'acronym': 'EDP-VENT', 'briefTitle': 'Phrenic Nerve Stimulation for Reducing Ventilation Duration in Acute Cerebral Infarction: A Multicenter Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Xuanwu Hospital, Beijing'}, 'officialTitle': 'Transcutaneous Electrical Phrenic Nerve Stimulation for Reducing Mechanical Ventilation Duration in Acute Cerebral Infarction: A Multicenter Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2025-161-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Transcutaneous electrical phrenic nerve stimulation for 14 days', 'interventionNames': ['Device: Transcutaneous electrical phrenic nerve stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control group', 'description': 'Sham stimulation for 14 days', 'interventionNames': ['Device: Sham (No Treatment)']}], 'interventions': [{'name': 'Transcutaneous electrical phrenic nerve stimulation', 'type': 'DEVICE', 'description': "Non-invasive transcutaneous electrical phrenic nerve stimulation which can cause explicit contraction of the diaphragm, and the stimulation current may be set to 5-30mA depending on the participant's condition.", 'armGroupLabels': ['Intervention group']}, {'name': 'Sham (No Treatment)', 'type': 'DEVICE', 'description': 'The stimulation current is set to 0.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Linlin Fan', 'role': 'CONTACT', 'email': 'windspring7139@163.com', 'phone': '86-010-83198899', 'phoneExt': '8640'}], 'facility': 'Xuanwu Hospital Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '050000', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'contacts': [{'name': 'Ya Chang', 'role': 'CONTACT', 'email': '949896097@qq.com', 'phone': '86-0311-87156771'}], 'facility': 'The First Hospital of Heibei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'zip': '100015', 'city': 'Beijing', 'country': 'China', 'contacts': [{'name': 'Meijuan Jiang', 'role': 'CONTACT', 'email': 'jmj4415@163.com', 'phone': '86-13811680287'}], 'facility': 'Beijing Ditan Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100054', 'city': 'Beijing', 'country': 'China', 'contacts': [{'name': 'Yanbo He', 'role': 'CONTACT', 'email': 'htyopen@163.com', 'phone': '86-010-83912719'}], 'facility': 'Beijing Hui Min Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100093', 'city': 'Beijing', 'country': 'China', 'contacts': [{'name': 'Zhonghua Shi', 'role': 'CONTACT', 'email': 'z.shi@mail.ccmu.edu.cn', 'phone': '86-010-62856765'}], 'facility': 'Sanbo Brain Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100700', 'city': 'Beijing', 'country': 'China', 'contacts': [{'name': 'Yanen Lv', 'role': 'CONTACT', 'email': 'sjwkl1@sohu.com', 'phone': '86-010-84015028'}], 'facility': 'Dongzhimen Hospital Beijing University of Chinese Medicine', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100730', 'city': 'Beijing', 'country': 'China', 'contacts': [{'name': 'Qinglin Yang', 'role': 'CONTACT', 'email': 'lin8082@sina.com', 'phone': '86-010-58266018'}], 'facility': 'Beijing Tongren Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '102400', 'city': 'Beijing', 'country': 'China', 'contacts': [{'name': 'Liang Chen', 'role': 'CONTACT', 'email': 'wildexreme@aliyun.com', 'phone': '86-010-69313443-8184'}], 'facility': 'The First Hospital of Fangshan District', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '102699', 'city': 'Beijing', 'country': 'China', 'contacts': [{'name': 'Huiliang Yang', 'role': 'CONTACT', 'email': 'yanghuiliang1981@sina.com', 'phone': '86-010-60283156'}], 'facility': "Beijing Daxing District People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Linlin Fan', 'role': 'CONTACT', 'email': 'windspring7139@163.com', 'phone': '86-010-83198899', 'phoneExt': '8640'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'ipdSharing': 'YES', 'description': 'After the research is completed and the results are published, the project leader can be contacted to obtain the original data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}