Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-02-21 @ 4:09 AM
Study NCT ID:
NCT02870894
Status:
UNKNOWN
Last Update Posted:
2016-08-18
First Post:
2016-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electrical Impedance Tomography for Quantification of Pulmonary Edema in Acute Respiratory Distress Syndrome Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-17', 'studyFirstSubmitDate': '2016-08-14', 'studyFirstSubmitQcDate': '2016-08-14', 'lastUpdatePostDateStruct': {'date': '2016-08-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison between a novel EIT-based method to estimate pulmonary edema (lung water ratio-EIT ) with a conventional measurement for EVLW using trans-cardiopulmonary thermodilution technique', 'timeFrame': 'once the patient was consented and enrolled'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Respiratory Distress Syndrome']}, 'referencesModule': {'references': [{'pmid': '31035265', 'type': 'DERIVED', 'citation': 'Zhao Z, He H, Luo J, Adler A, Zhang X, Liu R, Lan Y, Lu S, Luo X, Lei Y, Frerichs I, Huang X, Moller K. Detection of pulmonary oedema by electrical impedance tomography: validation of previously proposed approaches in a clinical setting. Physiol Meas. 2019 Jun 4;40(5):054008. doi: 10.1088/1361-6579/ab1d90.'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of pulmonary edema is a key factor in monitoring and guidance of therapy in acute respiratory distress syndrome (ARDS) patients. To date, methods available at the bedside for estimating the physiologic correlate of pulmonary edema, extravascular lung water(EVLW), often are unreliable or require invasive measurements. The purpose of the this study is to develop a novel approach to reliably assess extravascular lung water by electrical impedance tomography(EIT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult ICU patients with ARDS will be enrolled between August 2016 and August 2017 when they fulfilled the inclusion criteria,and unfulfilled the exclusion criteria below', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients will be included in this study if the following criteria have been met:\n\n1. Males and females \\> 18 years old and \\<85 years old (non-pregnant, non-lactating females).\n2. Patients fulfilled the Berlin diagnostic criteria of ARDS\n3. Signed written informed consent has been obtained\n4. Patients had monitoring system Pulse-Induced Contour Cardiac Output (PiCCO)\n\nExclusion Criteria:\n\n1. Females who are pregnant or lactating.\n2. Patients with contraindication of EIT(Skin abrasions or wounds in the chest area.Patients with pacemakers or paced EKG rhythms.Thoracic deformity. Severe subcutaneous emphysema)\n3. Patients \\<18 years old or \\> 85 years old\n4. Patients Without monitoring system Pulse-Induced Contour Cardiac Output (PiCCO)\n5. Patients with Cardiac function of grade 4 or patients with acute myocardial infarction or acute coronary syndrome'}, 'identificationModule': {'nctId': 'NCT02870894', 'briefTitle': 'Electrical Impedance Tomography for Quantification of Pulmonary Edema in Acute Respiratory Distress Syndrome Patients', 'organization': {'class': 'OTHER', 'fullName': "Sichuan Provincial People's Hospital"}, 'orgStudyIdInfo': {'id': 'SichuanPPH'}}, 'contactsLocationsModule': {'locations': [{'zip': '610072', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'hongli He, Ph.D', 'role': 'CONTACT', 'email': 'doctorhhl2016@126.com', 'phone': '+86-28-87393633'}, {'name': 'Xiaobo Huang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Hongli He, Ph.D', 'role': 'CONTACT', 'email': 'doctorhhl2016@126.com', 'phone': '+86-28-87393633'}], 'overallOfficials': [{'name': 'Xiaobo Huang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sichuan Academy of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Sichuan Provincial People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'He Hongli', 'investigatorAffiliation': "Sichuan Provincial People's Hospital"}}}}