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Definition of ARDS in Qinghai Province: Verification of Berlin Definition Plateau Criteria

Sponsor
Southeast University, China (Other)
Overall Status
Unknown status
CT.gov ID
NCT04199650
Collaborator
Affiliated Hospital of Qinghai University (Other)
253
Enrollment
1
Location
17
Anticipated Duration (Months)
14.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    253 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Other
    Official Title:
    Definition of Acute Respiratory Distress Syndrome in Plateau of Qinghai in China: Verification of Berlin Definition Plateau Criteria
    Actual Study Start Date :
    Apr 1, 2019
    Anticipated Primary Completion Date :
    Jan 30, 2020
    Anticipated Study Completion Date :
    Aug 30, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Mild ARDS

    153mmHg<PaO2/FiO2≤230mmHg
    Moderate ARDS

    76mmHg<PaO2/FiO2≤153mmHg
    Severe ARDS

    PaO2/FiO2≤76mmHg

    Outcome Measures

    Primary Outcome Measures

    1. ICU mortality [up to 24 weeks]

      Mortality during treatment in ICU

    2. 28-days mortality rate [28 days after discharge]

      Mortality at 28 days of hospitalization

    Secondary Outcome Measures

    1. Ventilator Free time [up to 24 weeks]

      Ventilator time not used in ICU

    2. Ventilator time [up to 24 weeks]

      Ventilator time in ICU

    3. Hospital length of stay [up to 24 weeks]

      Total length of stay in hospital

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 18 years of age

    • Meet the diagnostic criteria of ARDS

    • Receive invasive mechanical ventilation

    Exclusion Criteria:

    • Receive a large number of hormone shock therapy in a short period of time

    • Death within a short period of time (< 24 h) after mechanical ventilation

    • No chest imaging data

    • Data missing

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ChunPan Nanjing Jiangsu China 210000

    Sponsors and Collaborators

    • Southeast University, China
    • Affiliated Hospital of Qinghai University

    Investigators

    • Principal Investigator: Liu Xiaoqin, Bachelor, Affiliated Hospital of Qinghai University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chun Pan, Deputy chief physician, Southeast University, China
    ClinicalTrials.gov Identifier:
    NCT04199650
    Other Study ID Numbers:
    • ARDS Plateau Criteria
    First Posted:
    Dec 16, 2019
    Last Update Posted:
    Dec 16, 2019
    Last Verified:
    Dec 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Dec 16, 2019