Epidemiological Characteristics and Prediction System of Acute Respiratory Distress Syndrome

NCT ID: NCT06069466

Last Updated: 2023-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-15

Study Completion Date

2025-07-31

Brief Summary

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This project intends to adopt the multicenter prospective real-world study method to conduct a preliminary study on the incidence, grading, risk factors, respiratory support strategies, in-hospital mortality, 3-month mortality, 6-month mortality, 1-year mortality, quality of life, lung function and limb function recovery, cognitive function, return to work and other conditions of ARDS patients in RICU. By collecting 1,000 patients, a clinical database related to ARDS in China was established to provide essential data and ideas for promoting standardized diagnosis and treatment technology for ARDS patients and further clinical intervention research. At the same time, ARDS biobank was established in China-Japan Hospital and Xiangya Hospital to realize the integration of clinical data and sample resources, and the prediction model of ARDS survival and complications of tuberculosis clinical data and biological samples was established by using big data and AI technology.

Detailed Description

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Conditions

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Acute Respiratory Distress Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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ARDS patient

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* New or worsening respiratory symptoms less than 7 days after the acute blow.
* CT/X-ray: Double lung infiltration that cannot be fully explained by pleural effusion, lobar/whole atelectasis, and nodule.
* Respiratory failure that cannot be explained by heart failure or fluid overload
* After 15min assisted ventilation (PEEP or CPAP ≥ 5cmH2O) or HFNC with flow≥30L/min, PaO2/FiO2≤300mmHg
* Classification of ARDS: mild (200mmHg \< PaO2/FIO2 ≤ 300mmHg), moderate (100mmHg \< PaO2/FIO2 ≤ 200mmHg), and severe (PaO2/FIO2 ≤ 100mmHg) and 4 ancillary variables for severe ARDS

Exclusion Criteria

* younger than 18 years old
* Patients or family members refused to participate in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China-Japan Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Huang Xu

associate chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xu Huang, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Respiratory and Critical Care Medicine, China-Japan Friendship Hospital

Locations

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Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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2023-NHLHCRF-YYPP-TS-04

Identifier Type: -

Identifier Source: org_study_id

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