Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-01-07 @ 4:17 AM
Study NCT ID:
NCT05107167
Status:
COMPLETED
Last Update Posted:
2022-07-12
First Post:
2021-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electromagnetic Stimulation of the Phrenic Nerve of Intubated Patients With Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018908', 'term': 'Muscle Weakness'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-11', 'studyFirstSubmitDate': '2021-10-26', 'studyFirstSubmitQcDate': '2021-10-26', 'lastUpdatePostDateStruct': {'date': '2022-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1.Tidal volume generated by electromagentical stimulation of the phrenic nerve (ml)', 'timeFrame': 'approximately 15 minutes', 'description': 'Mean tidal volume of 10 consecutively stimulations of the phrenic nerve'}], 'secondaryOutcomes': [{'measure': 'Max inspiratory flow after stimulation', 'timeFrame': 'approximately 15 minutes', 'description': 'The maximal air flow created in the duct following stimulation of the N. phrenicus (meter / second)'}, {'measure': 'Abdominal extension maximum', 'timeFrame': 'approximately 15 minutes', 'description': 'Extension of the abdomen in centimeter measured via abdominal belt'}, {'measure': 'Air pressure during each breath', 'timeFrame': 'approximately 15 minutes', 'description': 'Change in pressure in the duct from expiration to inspiration (mbar)'}, {'measure': 'Diaphragmatic thickening fraction', 'timeFrame': 'approximately 15 minutes', 'description': 'Diaphragmatic contractility measured by ultrasound after N. phrenicus stimulation'}, {'measure': 'Feedback/Stimulation locus relation', 'timeFrame': 'approximately 15 minutes', 'description': 'When the stimulation locus is changed according to protocol the change of the triggered tidal volume is measured in % to the original location'}, {'measure': 'Latency between stimulation and feedback', 'timeFrame': 'approximately 15 minutes', 'description': 'Time between start and end of the stimulation in seconds'}, {'measure': 'Intensity/Contractility relation', 'timeFrame': 'approximately 15 minutes', 'description': 'Correlation between the simulation intensity and the diaphragmatic contractility'}, {'measure': 'Time to find the optimal stimulation point of the N. phrenicus', 'timeFrame': 'approximately 15 minutes', 'description': 'Time between first successful N. phrenicus stimulation and identification of the optimal stimulation locus in seconds'}, {'measure': 'Distance between anatomical landmarks and optimal stimulation locus', 'timeFrame': 'approximately 15 minutes', 'description': 'Distance between anatomical landmarks and optimal stimulation locus'}, {'measure': 'Reproducibility of stimulation answer', 'timeFrame': 'approximately 15 minutes', 'description': 'Variation of stimulated tidal volumes and diaphragm contraction using mean and standard deviation of each stimulation intensity'}, {'measure': 'Incidence of Adverse Events during stimulation', 'timeFrame': 'approximately 15 minutes', 'description': 'Adverse Events elicited by the electromagnetic stimulation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['VIDD', 'ICUAW', 'muscle weakness'], 'conditions': ['General Anaesthesia', 'Muscle Weakness']}, 'descriptionModule': {'briefSummary': 'Ventilator-induced diaphragmatic dysfunction is a common issue in critically ill patients. Muscle stimulation has shown to have beneficial effects in muscle groups on the extremities. A non-invasive way to stimulate the diaphragm would be the electromagnetic stimulation but it is currently unclear if that is feasible.\n\nIn this proof-of-concept trial the primary aim is to show that it is possible to induce a diaphragmatic contraction leading to an inspiration with a sufficient tidal volume via an external electromagnetic stimulation of the phrenic nerve in obese patients.', 'detailedDescription': 'During the time of first spontaneous breathing trial 60% of mechanically ventilated patients present with diaphragmatic weakness or also know as ventilator-induced diaphragmatic dysfunction (VIDD). The damage to the diaphragm in terms of muscle atrophy has been shown as early as 12 hours after initiation of mechanical ventilation. Recently, a correlation between diaphragmatic atrophy and mortality could be established.\n\nInduction of diaphragmatic contractions via stimulation of the phrenic nerve would be a possible method to prevent or treat VIDD. A possible modality would be the non-invasive electromagnetic stimulation but feasibility has not been established.\n\nIn this proof-of-concept trial the primary aim is to show that it is possible to induce a diaphragmatic contraction leading to an inspiration with a sufficient tidal volume via an external electromagnetic stimulation of the phrenic nerve in obese patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years of age\n* American Society of Anaesthesiologists Classification I or II\n* Planned anesthesia with intubation\n* Adipositas Grade II-III\n\nExclusion Criteria:\n\n* Chronic lung disease\n* Preexisting diaphragmatic weakness\n* Neurologic disease with known motor weakness\n* Paralysis of the phrenic nerve\n* Contraindication for any movement in the cervical vertebrae\n* Conditions that limit the movement of the diaphragm e.g. ascites, increased intraabdominal pressure.\n* Inability to communicate in the official language\n* Infections, lesions or stricture in the neck area\n* Implanted cardiac devices e.g. pace maker, defibrillator, event recorder\n* Implanted medical pumps e.g. left ventricular assist device\n* Metal implants in the upper body\n* Preganancy'}, 'identificationModule': {'nctId': 'NCT05107167', 'acronym': 'STIMIT-IA', 'briefTitle': 'Electromagnetic Stimulation of the Phrenic Nerve of Intubated Patients With Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Electromagnetic Stimulation of the Phrenic Nerve to Generate Contraction of the Diaphragm in Anesthetized and Intubated Patients With Obesity - a Proof-of-concept Study', 'orgStudyIdInfo': {'id': 'STIMIT-IA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electromagnetic stimulation', 'description': 'Electromagnetic stimulation of the phrenic nerve.', 'interventionNames': ['Device: Electromagnetic stimulation']}], 'interventions': [{'name': 'Electromagnetic stimulation', 'type': 'DEVICE', 'description': 'Electromagnetic stimulation of the phrenic nerve', 'armGroupLabels': ['Electromagnetic stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité - Univiversitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Stefan J Schaller, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charité - Universitätsmedizin Berlin, Berlin, Germany'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'After publication of scientific manuscript.', 'ipdSharing': 'YES', 'description': 'Deidentified data can be requested on reasonable scientific request.', 'accessCriteria': 'Deidentified data can be requested on reasonable scientific request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stimit AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Clinical Director', 'investigatorFullName': 'Stefan J Schaller', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}