Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-02-22 @ 7:23 AM
Study NCT ID:
NCT04199650
Status:
UNKNOWN
Last Update Posted:
2019-12-16
First Post:
2019-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Definition of ARDS in Qinghai Province: Verification of Berlin Definition Plateau Criteria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000532', 'term': 'Altitude Sickness'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 253}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2020-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-13', 'studyFirstSubmitDate': '2019-12-05', 'studyFirstSubmitQcDate': '2019-12-13', 'lastUpdatePostDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ICU mortality', 'timeFrame': 'up to 24 weeks', 'description': 'Mortality during treatment in ICU'}, {'measure': '28-days mortality rate', 'timeFrame': '28 days after discharge', 'description': 'Mortality at 28 days of hospitalization'}], 'secondaryOutcomes': [{'measure': 'Ventilator Free time', 'timeFrame': 'up to 24 weeks', 'description': 'Ventilator time not used in ICU'}, {'measure': 'Ventilator time', 'timeFrame': 'up to 24 weeks', 'description': 'Ventilator time in ICU'}, {'measure': 'Hospital length of stay', 'timeFrame': 'up to 24 weeks', 'description': 'Total length of stay in hospital'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ARDS', 'High Altitude']}, 'referencesModule': {'references': [{'pmid': '35280910', 'type': 'DERIVED', 'citation': 'Liu X, Pan C, Si L, Tong S, Niu Y, Qiu H, Gan G. Definition of Acute Respiratory Distress Syndrome on the Plateau of Xining, Qinghai: A Verification of the Berlin Definition Altitude-PaO2/FiO2-Corrected Criteria. Front Med (Lausanne). 2022 Feb 23;9:648835. doi: 10.3389/fmed.2022.648835. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': "The severity stratification criteria for acute respiratory distress syndrome (ARDS) in Xi'ning Qinghai province (mean altitude: 2200m) were clarified according to the oxygenation index (PaO2/FiO2).", 'detailedDescription': 'This study is a single-center retrospective study. According to the Berlin diagnostic standard, ARDS patients admitted to the Department of severe Medicine, affiliated Hospital of Qinghai University from January 2018 to December 2018 were divided into three groups: mild (153mmHg \\< PaO2/ FiO2 ≥ 230 mmHg), moderate (76mmHg \\< PaO2/ FiO2 ≥ 153 mmHg) and severe (PaO2/ FiO2 ≥ 76 mmHg). The ICU mortality, 28-day mortality, non-ventilator time in ICU, ICU hospitalization time and non-I hospitalization were observed respectively. The difference of CU time and total hospitalization days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'From January 2018 to December 2018, patients admitted to the department of critical care, affiliated hospital of qinghai university were diagnosed with acute respiratory distress syndrome according to Berlin Definition.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age\n* Meet the diagnostic criteria of ARDS\n* Receive invasive mechanical ventilation\n\nExclusion Criteria:\n\n* Receive a large number of hormone shock therapy in a short period of time\n* Death within a short period of time (\\< 24 h) after mechanical ventilation\n* No chest imaging data\n* Data missing'}, 'identificationModule': {'nctId': 'NCT04199650', 'briefTitle': 'Definition of ARDS in Qinghai Province: Verification of Berlin Definition Plateau Criteria', 'organization': {'class': 'OTHER', 'fullName': 'Southeast University, China'}, 'officialTitle': 'Definition of Acute Respiratory Distress Syndrome in Plateau of Qinghai in China: Verification of Berlin Definition Plateau Criteria', 'orgStudyIdInfo': {'id': 'ARDS Plateau Criteria'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mild ARDS', 'description': '153mmHg\\<PaO2/FiO2≤230mmHg'}, {'label': 'Moderate ARDS', 'description': '76mmHg\\<PaO2/FiO2≤153mmHg'}, {'label': 'Severe ARDS', 'description': 'PaO2/FiO2≤76mmHg'}]}, 'contactsLocationsModule': {'locations': [{'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guifen Gan, Bachelor', 'role': 'CONTACT', 'email': 'xzhd1991@163.com', 'phone': '15897083336'}, {'name': 'Xiaoqin Liu, Bachelor', 'role': 'CONTACT', 'email': 'liuxq0411@163.com', 'phone': '17809821708'}], 'facility': 'ChunPan', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Gan Guifen, Bachelor', 'role': 'CONTACT', 'email': 'xzhd1991@163.com', 'phone': '15897083336'}, {'name': 'Pan Chun, Doctor', 'role': 'CONTACT', 'email': 'panchun1982@gmail.com', 'phone': '13814009925'}], 'overallOfficials': [{'name': 'Liu Xiaoqin, Bachelor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Affiliated Hospital of Qinghai University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southeast University, China', 'class': 'OTHER'}, 'collaborators': [{'name': 'Affiliated Hospital of Qinghai University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy chief physician', 'investigatorFullName': 'Chun Pan', 'investigatorAffiliation': 'Southeast University, China'}}}}