Diagnostic Criteria of ARDS at High Altitudes in Western China

December 31, 2019 updated by: Guifen Gan, Affiliated Hospital of Qinghai University
The severity of ARDS in high altitude areas was classified according to the Berlin standard high altitude area Oxygenation.

Study Overview

Status

Unknown

Conditions

Detailed Description

Will between January 2018 and December 2018 in lanzhou, and so on more than 1500 meters above sea level in qinghai region 10 intensive care patients with ARDS, respectively according to the standard in Berlin, Berlin, diagnosis of high altitude ARDS calibration standards and zhang the plateau region in western China put forward by the diagnosis of ALI/ARDS severity classification, observation group patients were ICU mortality, within 28 days, ICU mortality did not use breathing machine time, mechanical ventilation, ICU length of hospital stay, and the differences in hospitalization days.

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Qinghai
      • Xining, Qinghai, China, 810000
        • Recruiting
        • Affiliated Hospital of Qinghai University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 2019 to 2022, patients diagnosed with ARDS were admitted to the department of critical care medicine of qinghai university affiliated hospital, qinghai provincial people's hospital and other selected units

Description

Inclusion Criteria:

  • age ≥18
  • the primary disease of ARDS caused by systemic infection, shock, severe pneumonia, aspiration and trauma
  • blood gas analysis showed a progressive decline in pulmonary ventilation function
  • PEEP≥5cmH2O Exclusion criteria
  • Receive a large amount of hormone shock therapy in a short period of time
  • Died within a short time (< 24h) after mechanical ventilation
  • Lack of data
  • No chest imaging data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Mild ARDS
Oxygenation standards were calculated based on the Berlin diagnostic high element correction formula combined with local atmospheric pressure
Moderate ARDS
Oxygenation standards were calculated based on the Berlin diagnostic high element correction formula combined with local atmospheric pressure
Severe ARDS
Oxygenation standards were calculated based on the Berlin diagnostic high element correction formula combined with local atmospheric pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU mortality
Time Frame: up to 24 weeks
mortality during treatment in ICU
up to 24 weeks
28 days mortality
Time Frame: up to 24 weeks
mortality at 28 days of hospitalization
up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ventilator time
Time Frame: up to 24 weeks
Ventilator time in ICU
up to 24 weeks
Ventilator Free time
Time Frame: up to 24 weeks
No ventilator use time in ICU
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affiliated Hospital of Qinghai University

Collaborators

Children's Hospital of Fudan University

Investigators

  • Principal Investigator: Gan Guifen, Bachelor, Affiliated Hospital of Qinghai University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

December 30, 2019

First Submitted That Met QC Criteria

December 31, 2019

First Posted (Actual)

January 2, 2020

Study Record Updates

Last Update Posted (Actual)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 31, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ARDS Criteria high altitudes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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