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

ARDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04199650
• Other study ID #: ARDS Plateau Criteria
• Status: Recruiting
• Start date: April 1, 2019
• Est. completion date: August 30, 2020

Study information

• Verified date: December 2019
• Source: Southeast University, China
• Contact: Gan Guifen, Bachelor
• Phone: 15897083336
• Email: xzhd1991[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 253
• Est. completion date: August 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ARDS
• High Altitude

Locations

Country	Name	City	State
China	ChunPan	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Southeast University, China	Affiliated Hospital of Qinghai University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICU mortality	Mortality during treatment in ICU	up to 24 weeks
Primary	28-days mortality rate	Mortality at 28 days of hospitalization	28 days after discharge
Secondary	Ventilator Free time	Ventilator time not used in ICU	up to 24 weeks
Secondary	Ventilator time	Ventilator time in ICU	up to 24 weeks
Secondary	Hospital length of stay	Total length of stay in hospital	up to 24 weeks