NCT04215666

Brief Summary

The severity of ARDS in high altitude areas was classified according to the Berlin standard high altitude area Oxygenation.

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
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

Typical duration for all trials

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

December 1, 2019

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

December 30, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

1.1 years

First QC Date

December 30, 2019

Last Update Submit

December 31, 2019

Conditions

Keywords

ARDSDefinitionshigh-altitude

Outcome Measures

Primary Outcomes (2)

  • ICU mortality

    mortality during treatment in ICU

    up to 24 weeks

  • 28 days mortality

    mortality at 28 days of hospitalization

    up to 24 weeks

Secondary Outcomes (2)

  • Ventilator Free time

    up to 24 weeks

  • Ventilator time

    up to 24 weeks

Study Arms (3)

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

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated hospital of qinghai university

Xining, Qinghai, 810000, China

RECRUITING

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Gan Guifen, 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
Chief physician

Study Record Dates

First Submitted

December 30, 2019

First Posted

January 2, 2020

Study Start

December 1, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2022

Last Updated

January 2, 2020

Record last verified: 2019-12

Locations