Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-29 @ 11:31 PM
Study NCT ID:
NCT05105932
Status:
UNKNOWN
Last Update Posted:
2021-11-03
First Post:
2021-01-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Study of Regional Lung Ventilation-perfusion by EIT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-24', 'studyFirstSubmitDate': '2021-01-28', 'studyFirstSubmitQcDate': '2021-10-24', 'lastUpdatePostDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Regional pulmonary perfusion by EIT', 'timeFrame': '1 Day', 'description': 'Using EIT to measure the regional pulmonary perfusion and calculate ventilation/perfusion ratio'}, {'measure': 'Regional pulmonary perfusion by CTPA', 'timeFrame': '1 Day', 'description': 'Using CTPA to measure the regional pulmonary perfusion and calculate ventilation/perfusion ratio'}], 'secondaryOutcomes': [{'measure': 'Regional pulmonary ventilation index by EIT', 'timeFrame': '1 Day', 'description': 'Regional pulmonary ventilation index by EIT, including GI: global inhomogeneity CoV: center of ventilation, ROI: region of interest'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['EIT', 'pulmonary perfusion'], 'conditions': ['Pulmonary Ventilation', 'Pulmonary Perfusion']}, 'descriptionModule': {'briefSummary': 'This is a prospective observational trial. The purpose of this study is to explore the feasibility of EIT monitoring pulmonary blood flow and the consistency and difference between EIT monitoring pulmonary local ventilation blood flow and SPECT and CTPA monitoring methods'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who need CTPA examination in the Department of nuclear medicine / radiology of Peking Union Medical College Hospital', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Admission to ICU was less than 72 hours;\n2. Age ≥ 18 years old and ≤ 80 years old;\n3. Volunteer to participate after communicating with patients' family members;\n\nExclusion Criteria:\n\n1. The patients with heart implants could not be monitored by EIT;\n2. Patients or their families refused to participate in the study;\n3. Hypernatremia"}, 'identificationModule': {'nctId': 'NCT05105932', 'briefTitle': 'The Study of Regional Lung Ventilation-perfusion by EIT', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'The Study of Regional Lung Ventilation-perfusion by EIT', 'orgStudyIdInfo': {'id': 'PUMCH-EIT-PE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'EIT group', 'description': 'patients went through EIT detection'}, {'label': 'CTPA group', 'description': 'patients went through CTPA detection'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yun Long', 'role': 'CONTACT', 'email': 'ly_icu@aliyun.com', 'phone': '13911608699'}, {'name': 'Siyi Yuan', 'role': 'CONTACT', 'email': 'yuansiyizqh@163.com', 'phone': '15201518815'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yun Long', 'role': 'CONTACT', 'email': 'ly_icu@aliyun.com', 'phone': '13911608699'}, {'name': 'Siyi Yuan', 'role': 'CONTACT', 'email': 'yuansiyizqh@163.com', 'phone': '15201518815'}], 'overallOfficials': [{'name': 'Yun Long', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}