Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
Study NCT ID:
NCT04215666
Status:
UNKNOWN
Last Update Posted:
2020-01-02
First Post:
2019-12-30
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diagnostic Criteria of ARDS at High Altitudes in Western China
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': 3000}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-31', 'studyFirstSubmitDate': '2019-12-30', 'studyFirstSubmitQcDate': '2019-12-31', 'lastUpdatePostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ICU mortality', 'timeFrame': 'up to 24 weeks', 'description': 'mortality during treatment in ICU'}, {'measure': '28 days mortality', 'timeFrame': 'up to 24 weeks', 'description': 'mortality at 28 days of hospitalization'}], 'secondaryOutcomes': [{'measure': 'Ventilator Free time', 'timeFrame': 'up to 24 weeks', 'description': 'No ventilator use time in ICU'}, {'measure': 'Ventilator time', 'timeFrame': 'up to 24 weeks', 'description': 'Ventilator time in ICU'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ARDS', 'Definitions', 'high-altitude'], 'conditions': ['ARDS']}, 'descriptionModule': {'briefSummary': 'The severity of ARDS in high altitude areas was classified according to the Berlin standard high altitude area Oxygenation.', 'detailedDescription': 'Will between January 2018 and December 2018 in lanzhou, and so on more than 1500 meters above sea level in qinghai region 10 intensive care patients with ARDS, respectively according to the standard in Berlin, Berlin, diagnosis of high altitude ARDS calibration standards and zhang the plateau region in western China put forward by the diagnosis of ALI/ARDS severity classification, observation group patients were ICU mortality, within 28 days, ICU mortality did not use breathing machine time, mechanical ventilation, ICU length of hospital stay, and the differences in hospitalization days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "From 2019 to 2022, patients diagnosed with ARDS were admitted to the department of critical care medicine of qinghai university affiliated hospital, qinghai provincial people's hospital and other selected units", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥18\n* the primary disease of ARDS caused by systemic infection, shock, severe pneumonia, aspiration and trauma\n* blood gas analysis showed a progressive decline in pulmonary ventilation function\n* PEEP≥5cmH2O Exclusion criteria\n* Receive a large amount of hormone shock therapy in a short period of time\n* Died within a short time (\\< 24h) after mechanical ventilation\n* Lack of data\n* No chest imaging data'}, 'identificationModule': {'nctId': 'NCT04215666', 'briefTitle': 'Diagnostic Criteria of ARDS at High Altitudes in Western China', 'organization': {'class': 'OTHER', 'fullName': 'Affiliated Hospital of Qinghai University'}, 'officialTitle': 'Diagnostic Criteria of ARDS at High Altitudes in Western China', 'orgStudyIdInfo': {'id': 'ARDS Criteria high altitudes'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mild ARDS', 'description': 'Oxygenation standards were calculated based on the Berlin diagnostic high element correction formula combined with local atmospheric pressure'}, {'label': 'Moderate ARDS', 'description': 'Oxygenation standards were calculated based on the Berlin diagnostic high element correction formula combined with local atmospheric pressure'}, {'label': 'Severe ARDS', 'description': 'Oxygenation standards were calculated based on the Berlin diagnostic high element correction formula combined with local atmospheric pressure'}]}, 'contactsLocationsModule': {'locations': [{'zip': '810000', 'city': 'Xining', 'state': 'Qinghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Gan Guifen, Bachelor', 'role': 'CONTACT', 'email': 'xzhd1991@163.com', 'phone': '15897083336'}], 'facility': 'Affiliated hospital of qinghai university', 'geoPoint': {'lat': 36.62554, 'lon': 101.75739}}], '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': 'Gan Guifen, Bachelor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Affiliated Hospital of Qinghai University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Affiliated Hospital of Qinghai University', 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Hospital of Fudan University", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician', 'investigatorFullName': 'Guifen Gan', 'investigatorAffiliation': 'Affiliated Hospital of Qinghai University'}}}}