CClinicalTrials.gg
Sign In
Status unknownNCT04199650Updated Dec 16, 2019

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

An observational study in ARDS and High Altitude, sponsored by Southeast University, China. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-16.

Sponsored by Southeast University, China · Observational

The sponsor has not verified this record recently (last verified Dec 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Other
Enrollment
253
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • ARDS
  • High Altitude
03

In context

Lead sponsor

Southeast University, China is the lead sponsor of 164 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  • 18 years of age
  • Meet the diagnostic criteria of ARDS
  • Receive invasive mechanical ventilation

Exclusion criteria

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
05

Study design

Observational model
Case-only
Time perspective
Other
Enrollment
253 participants (estimated)
Target follow-up
1 Month
Patient registry
Yes

Groups and cohorts

  • Mild ARDS

    153mmHg\<PaO2/FiO2≤230mmHg

  • Moderate ARDS

    76mmHg\<PaO2/FiO2≤153mmHg

  • Severe ARDS

    PaO2/FiO2≤76mmHg

06

What researchers measure

Primary outcomes

  1. ICU mortality

    Mortality during treatment in ICU

    Time frame: up to 24 weeks

  2. 28-days mortality rate

    Mortality at 28 days of hospitalization

    Time frame: 28 days after discharge

Secondary outcomes

  1. Ventilator Free time

    Ventilator time not used in ICU

    Time frame: up to 24 weeks

  2. Ventilator time

    Ventilator time in ICU

    Time frame: up to 24 weeks

  3. Hospital length of stay

    Total length of stay in hospital

    Time frame: up to 24 weeks

07

Study locations

1 of 1 sites recruiting
  • ChunPan
    Nanjing, Jiangsu 210000, China
    Recruiting
08

References and documents

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. PubMed 35280910 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04199650
Lead sponsor
Southeast University, China
Collaborators
Affiliated Hospital of Qinghai University
Responsible party
Chun Pan (Deputy chief physician, Southeast University, China) — Principal investigator
First posted
Dec 16, 2019
Start date
Apr 1, 2019
Primary completion
Jan 30, 2020 (estimated)
Completion
Aug 30, 2020 (estimated)
Last update
Dec 16, 2019

Study contacts

Gan Guifen, Bachelor
Contact
xzhd1991@163.com
15897083336
Pan Chun, Doctor
Contact
panchun1982@gmail.com
13814009925
Liu Xiaoqin, Bachelor
principal investigator · Affiliated Hospital of Qinghai University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Southeast University, China

Start the discussion