Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:34 AM
Study NCT ID:
NCT07327268
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-08
First Post:
2025-12-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cyclic On-off Switching of Pulmonary Blood Flow in Moderate to Severe ARDS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055371', 'term': 'Acute Lung Injury'}], 'ancestors': [{'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'targetDuration': '28 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-25', 'studyFirstSubmitDate': '2025-12-25', 'studyFirstSubmitQcDate': '2025-12-25', 'lastUpdatePostDateStruct': {'date': '2026-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percent of "Cyclic On-Off Switching"', 'timeFrame': '15min', 'description': '"Cyclic On-Off Switching" was assessed by 3D-EIT'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ARDS (Acute Respiratory Distress Syndrome)', 'Electrical Impedance Tomography (EIT)', 'Pulmonary Perfusion']}, 'descriptionModule': {'briefSummary': 'Although the theoretical model of "cyclic on-off switching of pulmonary blood flow" provides a crucial perspective for understanding VILI, its clinical validation and real-time intervention face significant obstacles. The fundamental reason lies in the lack of pulmonary microcirculation monitoring technology capable of bedside, non-invasive, continuous operation with sufficient spatiotemporal resolution. Nowadays, a novel 3D-EIT can perform real-time and non-invasive assessment of the distribution of pulmonary blood flow. However, if 3D-EIT can help to identify "cyclic on-off switching of pulmonary blood flow" is still unclear.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive adult patients admitted to our ICU were screened for inclusion and exclusion criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult patients with mechanical ventilation\n2. diagnosis of moderate to severe ARDS no more than 72 hours\n\nExclusion Criteria:\n\n1. Chronic respiratory diseases that required long-term oxygen therapy, such as pulmonary fibrosis or chronical obstructive pulmonary disease\n2. Contraindications to EIT (e.g., active implantable device, chest malformation, unstable spinal injuries or fractures, and open chest wounds)\n3. Undrained pneumothorax or pneumomediastinum,\n4. Hemodynamic instability\n5. Pregnancy\n6. Refusal by family or the attending physician to participate in the study.'}, 'identificationModule': {'nctId': 'NCT07327268', 'briefTitle': 'Cyclic On-off Switching of Pulmonary Blood Flow in Moderate to Severe ARDS', 'organization': {'class': 'OTHER', 'fullName': 'Southeast University, China'}, 'officialTitle': 'Cyclic On-off Switching of Pulmonary Blood Flow in Moderate to Severe ARDS Patients With Mechanical Ventilation', 'orgStudyIdInfo': {'id': '3D-EIT perfusion'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'phase 1', 'description': 'patients ventilated with a tidal volume of 4ml/kg pbw'}, {'label': 'phase 2', 'description': 'patients ventilated with a tidal volume of 6ml/kg pbw'}, {'label': 'phase 3', 'description': 'patients ventilated with a tidal volume of 8ml/kg pbw'}]}, 'contactsLocationsModule': {'locations': [{'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'yuan xueyan, MD', 'role': 'CONTACT', 'email': '18826401594@163.com', 'phone': '+86 83262550'}], 'facility': 'Zhongda Hospital, School of Medicine, Southeast University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'ling liu Liu, PhD', 'role': 'CONTACT', 'email': 'liulingdoctor@126.com', 'phone': '+86 83262550'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southeast University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ling Liu', 'investigatorAffiliation': 'Southeast University, China'}}}}