Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-01-16 @ 3:06 PM
Study NCT ID:
NCT06502405
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-16
First Post:
2024-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Research on the Application of Electrical Impedance Tomography in Bronchial Challenge Testing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-09', 'studyFirstSubmitDate': '2024-07-09', 'studyFirstSubmitQcDate': '2024-07-09', 'lastUpdatePostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'global inhomogeneity index （GI）', 'timeFrame': '1day', 'description': 'Measured by EIT, used to describe the overall degree of spatial heterogeneity of ventilation.'}, {'measure': 'forced expiratory volume in 1s (FEV1)', 'timeFrame': '1day', 'description': 'The forced expiratory volume in 1s measured during pulmonary function tests.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to examine whether electrical impedance tomography (EIT) was capable of identifying the deteriorated lung function on a regional level during bronchial challenge testing and whether EIT may provide additional information during bronchial challenge testing and identify spatial and temporal heterogeneity of regional lung function.', 'detailedDescription': 'The content of this study includes:\n\n1. Can EIT identify the uneven ventilation caused by airway contraction in patients during bronchial provocation tests.\n2. Can EIT monitor airway contraction in patients before Spirometer examination after inhaling activators.\n3. Can EIT observe uneven ventilation caused by airway contraction through tidal breathing after the patient inhales activator.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients need to exclude or confirm a suspected diagnosis of asthma through bronchial challenge testing.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria：\n\n1. Patients suspected of asthma who require bronchial challenge testing.\n2. The Bronchodilator responsiveness testing is negative.\n3. patients with a pre-bronchodilator FEV1 \\>60% predicted.\n4. No contraindications for bronchial provocation test examination.\n5. Fully understand the purpose and significance of this study, and voluntarily participate in the research.\n\nExclusion Criteria:\n\n1\\. patients with a pre-bronchodilator FEV1≤60% predicted.\n\n1. Contraindications for bronchial challenge testing.\n2. Pregnant or lactating women.\n3. After pacemaker surgery.'}, 'identificationModule': {'nctId': 'NCT06502405', 'briefTitle': 'Research on the Application of Electrical Impedance Tomography in Bronchial Challenge Testing', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Research on the Application of Electrical Impedance Tomography in Bronchial Challenge Testing', 'orgStudyIdInfo': {'id': 'EIT and PFTs'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Lu Cao, Master', 'role': 'CONTACT', 'email': 'caolu301@163.om', 'phone': '13810389517'}], 'overallOfficials': [{'name': 'Fei Xie, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chinese PLA General Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Within 1 year after the publication of research results.', 'ipdSharing': 'YES', 'description': 'Study Protocol and research data.', 'accessCriteria': 'Can be obtained from the main researcher.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'wang kaifei', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Deputy chief physician', 'investigatorFullName': 'wang kaifei', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}