NCT04199650

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
253

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 16, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
Last Updated

December 16, 2019

Status Verified

December 1, 2019

Enrollment Period

10 months

First QC Date

December 5, 2019

Last Update Submit

December 13, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Ventilator Free time

    up to 24 weeks

  • Ventilator time

    up to 24 weeks

  • Hospital length of stay

    up to 24 weeks

Study Arms (3)

Mild ARDS

153mmHg\<PaO2/FiO2≤230mmHg

Moderate ARDS

76mmHg\<PaO2/FiO2≤153mmHg

Severe ARDS

PaO2/FiO2≤76mmHg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ChunPan

Nanjing, Jiangsu, 210000, China

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Liu Xiaoqin, Bachelor

    Affiliated Hospital of Qinghai University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gan Guifen, Bachelor

CONTACT

Pan Chun, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy chief physician

Study Record Dates

First Submitted

December 5, 2019

First Posted

December 16, 2019

Study Start

April 1, 2019

Primary Completion

January 30, 2020

Study Completion

August 30, 2020

Last Updated

December 16, 2019

Record last verified: 2019-12

Locations