NCT05493839

Brief Summary

This study is a single-center retrospective study. According to the Berlin diagnostic standard, ARDS patients admitted to the Department of severe Medicine, Golmud People's Hospital from January 2015 to june 2022 were divided into three groups: mild (142mmHg \< PaO2/ FiO2 ≤ 213 mmHg), moderate (71mmHg \< PaO2/ FiO2 ≤ 142mmHg) and severe (PaO2/ FiO2 ≤ 71 mmHg). The ICU mortality, 28-day mortality, non-ventilator time in ICU, ICU hospitalization time observed respectively.

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
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2022

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2022

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

August 9, 2022

Status Verified

August 1, 2022

Enrollment Period

2 months

First QC Date

August 7, 2022

Last Update Submit

August 7, 2022

Conditions

Ards

Outcome Measures

Primary Outcomes (2)

  • ICU mortality

    Mortality during treatment in ICU

    up to 24 weeks

  • 28-days mortality rate

    28-days mortality rate \[ Time Frame: 28 days after discharge \] Mortality at 28 days of hospitalization

    up to 24 weeks

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)

Plateau Criteria

mild ： 142mmHg \< PaO2/ FiO2 ≤ 213 mmHg moderate ： 71mmHg \< PaO2/ FiO2 ≤ 142mmHg severe： PaO2/ FiO2 ≤ 71 mmHg

Berlin Definition

mild ： 200mmHg \< PaO2/ FiO2 ≤ 300 mmHg moderate ： 100mmHg \< PaO2/ FiO2 ≤ 200mmHg severe： PaO2/ FiO2 ≤ 100 mmHg

zhang

ARDS：PaO2/FiO2≤100mmHg ALI ：100mmHg\<PaO2/FiO2≤150mmHg

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study is a single-center retrospective study. According to the Berlin diagnostic standard, ARDS patients admitted to the Department of severe Medicine, Golmud People's Hospital from January 2015 to june 2022 were divided into three groups: mild (142mmHg \< PaO2/ FiO2 ≤ 213 mmHg), moderate (71mmHg \< PaO2/ FiO2 ≤ 142mmHg) and severe (PaO2/ FiO2 ≤ 71 mmHg).

You may qualify if:

  • Meet the diagnostic criteria of ARDS

You may not qualify if:

  • length of stay in hospital less than 48h Data missing younger than 18 years or older than 80 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

August 7, 2022

First Posted

August 9, 2022

Study Start

June 20, 2022

Primary Completion

August 8, 2022

Study Completion

August 30, 2022

Last Updated

August 9, 2022

Record last verified: 2022-08

Locations

CN(1)