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A Reverification of the Berlin Definition Plateau Criteria in Golmud

Sponsor
Southeast University, China (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05493839
Collaborator
(none)
160
Enrollment
1
Location
2.3
Anticipated Duration (Months)
68.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a single-center retrospective study. According to the Berlin diagnostic standard, ARDS patients admitted to the Department of severe Medicine, Golmud People's Hospital from January 2015 to june 2022 were divided into three groups: mild (142mmHg < PaO2/ FiO2 ≤ 213 mmHg), moderate (71mmHg < PaO2/ FiO2 ≤ 142mmHg) and severe (PaO2/ FiO2 ≤ 71 mmHg). The ICU mortality, 28-day mortality, non-ventilator time in ICU, ICU hospitalization time observed respectively.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    160 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    A Reverification of the Berlin Definition Plateau Criteria in Golmud
    Actual Study Start Date :
    Jun 20, 2022
    Actual Primary Completion Date :
    Aug 8, 2022
    Anticipated Study Completion Date :
    Aug 30, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Plateau Criteria

    mild ： 142mmHg < PaO2/ FiO2 ≤ 213 mmHg moderate ： 71mmHg < PaO2/ FiO2 ≤ 142mmHg severe： PaO2/ FiO2 ≤ 71 mmHg
    Berlin Definition

    mild ： 200mmHg < PaO2/ FiO2 ≤ 300 mmHg moderate ： 100mmHg < PaO2/ FiO2 ≤ 200mmHg severe： PaO2/ FiO2 ≤ 100 mmHg
    zhang

    ARDS：PaO2/FiO2≤100mmHg ALI ：100mmHg<PaO2/FiO2≤150mmHg

    Outcome Measures

    Primary Outcome Measures

    1. ICU mortality [up to 24 weeks]

      Mortality during treatment in ICU

    2. 28-days mortality rate [up to 24 weeks]

      28-days mortality rate [ Time Frame: 28 days after discharge ] Mortality at 28 days of hospitalization

    Secondary Outcome Measures

    1. Ventilator Free time [up to 24 weeks]

      Ventilator Free time in ICU

    2. Ventilator time [up to 24 weeks]

      Ventilator time in ICU

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

      Hospital length of stay in hospital

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Meet the diagnostic criteria of ARDS
    Exclusion Criteria:
    • length of stay in hospital less than 48h Data missing younger than 18 years or older than 80 years

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhongda Hospital, Southeast University Nanjing Jiangsu China 210009

    Sponsors and Collaborators

    • Southeast University, China

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chun Pan, doctor, Southeast University, China
    ClinicalTrials.gov Identifier:
    NCT05493839
    Other Study ID Numbers:
    • ARDS in Golmud
    First Posted:
    Aug 9, 2022
    Last Update Posted:
    Aug 9, 2022
    Last Verified:
    Aug 1, 2022
    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 Aug 9, 2022