Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2025-12-29 @ 11:36 PM
Study NCT ID:
NCT05441657
Status:
COMPLETED
Last Update Posted:
2025-09-25
First Post:
2022-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Visualizing Regional Lung Ventilation in Patients With Postacute-COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-20', 'size': 241105, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-06-15T08:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2022-06-29', 'studyFirstSubmitQcDate': '2022-06-29', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pathogenic changes in regional lung ventilation', 'timeFrame': 'until July 2022', 'description': 'pathogenic changes in regional lung ventilation considered'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['post-acute COVID-19 syndrome', 'EIT', 'Electric impedance tomographie', 'long-COVID', 'post-COVID-19 Syndrome (PCS)'], 'conditions': ['Ventilatory Defect', 'COVID-19', 'Post-acute COVID-19 Syndrome', 'Electric Impedance Tomography', 'Post-COVID-19 Syndrome']}, 'descriptionModule': {'briefSummary': 'There is a lack of data of spontaneous breathing patients with post-COVID-19 syndrome (PCS) examined by Electrical impedance tomography (EIT). We compare 100 patients with PCS with 50 healthy probands.', 'detailedDescription': 'When treating patients with dyspnoea, conventional diagnostic tools (computed tomography, spirometry, body plethysmography) often fail to detect pathological changes, making it difficult for the treating physician to choose an appropriate therapeutic approach. Therefore, it would be desirable to have an examination method that reveals the pulmonary changes in postacute Corona-Virus-Disease-2019 (COVID-19) syndrome (PCS) patients that remain hidden from other diagnostic procedures.\n\nElectrical impedance tomography (EIT) is a non-invasive and radiation-free imaging technique that can show the regional ventilation of the lungs almost "in real-time" based on the changes in the electrical impedance of the thorax during inspiration and expiration. This method is based on the observation that the electrical conductivities of biological tissues vary considerably depending on their nature and functional state. Clinical questions in which the inhomogeneity of lung ventilation is to be analysed (e.g., under- or overinflation of individual lung areas, lung collapse, etc.) can be investigated particularly well with EIT since intrathoracic impedance changes correlate strongly with changes in regional lung ventilation.\n\nUp to now, EIT has mainly been used as a monitoring method in intensive care medicine to adapt ventilation settings and other therapeutic measures to the individual needs of patients. In this field, the method has proven useful for obtaining an overview of the distribution of a respiratory volume in a transverse EIT slice, comparing different lung regions, identifying inhomogeneities and assessing regional ventilation during spontaneous breathing.\n\nThe aim of this case-control study is to use EIT data obtained during routine examinations of post-COVID patients to analyse whether patients with PCS show more distinct lung alterations than the control group. Maybe these lung alterations correlate with dyspnea most patients report subjectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '100 patients with postacute COVID-19 syndrome who present themselves at the outpatient clinic of the University hospital in Jena (JUH) were examined by EIT. 50 lunghealthy volunteers were examined by EIT at JUH.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* for control group: no current lung diseases, over 18 years old\n* for patients with postacute COVID-19 syndrome: over 18 years, positive SARS-CoV-2-PCR\n\nExclusion Criteria:\n\n* heart pacemaker\n* epilepsy\n* BMI over 50'}, 'identificationModule': {'nctId': 'NCT05441657', 'acronym': 'ViReVentPoCov', 'briefTitle': 'Visualizing Regional Lung Ventilation in Patients With Postacute-COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Jena University Hospital'}, 'officialTitle': 'Visualisation of Changes in Regional Ventilation in Dyspnoeic Postacute COVID-19 Patients: A Case-control Study Using Electrical Impedance Tomography (EIT)', 'orgStudyIdInfo': {'id': 'KIM-IV-EIT-04'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'dyspnoeic patients with post-acute COVID-19 syndrome', 'description': '100 patients with/without persisting dyspnea after COVID-19 disease were examined by Electric Impedance Tomography (EIT).'}, {'label': 'control group', 'description': '50 healthy volunteers with no lung disease were voluntarily examined by Electric Impedance Tomography.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07747', 'city': 'Jena', 'state': 'Thuringia', 'country': 'Germany', 'facility': 'Jena university hospital', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}], 'overallOfficials': [{'name': 'Jan-Christoph Lewejohann, Dr.med.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Jena University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jan-Christoph Lewejohann', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'Jan-Christoph Lewejohann', 'investigatorAffiliation': 'Jena University Hospital'}}}}