A Reverification of the Berlin Definition Plateau Criteria in Golmud

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Ards

• Study Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital, Southeast University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU mortality	Mortality during treatment in ICU	up to 24 weeks
28-days mortality rate	28-days mortality rate [ Time Frame: 28 days after discharge ] Mortality at 28 days of hospitalization	up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilator Free time	Ventilator Free time in ICU	up to 24 weeks
Ventilator time	Ventilator time in ICU	up to 24 weeks
Hospital length of stay	Hospital length of stay in hospital	up to 24 weeks

Collaborators and Investigators

• Sponsor: Southeast University, China

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2022
• Primary Completion (Actual): August 8, 2022
• Study Completion (Anticipated): August 30, 2022

Study Registration Dates

• First Submitted: August 7, 2022
• First Submitted That Met QC Criteria: August 7, 2022
• First Posted (Actual): August 9, 2022

Study Record Updates

• Last Update Posted (Actual): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 7, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: ARDS in Golmud

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No