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

Definition of Acute Respiratory Distress Syndrome in Plateau of Qinghai in China: Verification of Berlin Definition Plateau Criteria

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).

Study Overview

• Status: Unknown
• Conditions: ARDS; High Altitude

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 Type: Observational
• Enrollment (Anticipated): 253

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • ChunPan
      • Contact: Guifen Gan, Bachelor; Phone Number: 15897083336; Email: xzhd1991@163.com
      • Contact: Xiaoqin Liu, Bachelor; Phone Number: 17809821708; Email: liuxq0411@163.com

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Mild ARDS; 153mmHg<PaO2/FiO2≤230mmHg
Moderate ARDS; 76mmHg<PaO2/FiO2≤153mmHg
Severe ARDS; PaO2/FiO2≤76mmHg

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	Mortality at 28 days of hospitalization	28 days after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilator time	Ventilator time in ICU	up to 24 weeks
Ventilator Free time	Ventilator time not used in ICU	up to 24 weeks
Hospital length of stay	Total length of stay in hospital	up to 24 weeks

Collaborators and Investigators

• Sponsor: Southeast University, China
• Collaborators: Affiliated Hospital of Qinghai University
• Investigators: Principal Investigator: Liu Xiaoqin, Bachelor, Affiliated Hospital of Qinghai University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Anticipated): January 30, 2020
• Study Completion (Anticipated): August 30, 2020

Study Registration Dates

• First Submitted: December 5, 2019
• First Submitted That Met QC Criteria: December 13, 2019
• First Posted (Actual): December 16, 2019

Study Record Updates

• Last Update Posted (Actual): December 16, 2019
• Last Update Submitted That Met QC Criteria: December 13, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: ARDS Plateau Criteria

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No