Epidemiological Characteristics and Prediction System of Acute Respiratory Distress Syndrome

NCT06069466 | Unknown

• 1 other identifier: 2023-NHLHCRF-YYPP-TS-04
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Respiratory Distress Syndrome

Keywords

ARDS; mortality; incidence; prognosis; predictive model; AI

Outcome Measures

Primary Outcomes (1)

• the prognosis of ARDS patients

  ICU mortality, 28-day mortality, 90-day mortality and 1-year mortality of ARDS patients

  from 28d to 1 year

Secondary Outcomes (7)

• Incidence of ARDS in ICUs

  2 years

• Length of hospital stay in ARDS patients

  during hospitalization

• VFDs within 28 days

  28 days

• Long-term quality of life and long-term lung function

  1 year

• Rates of mechanical ventilation strategies are consistent with guidelines rates of rates of mechanical ventilation strategies consistent with guidelines

  during hospitalization

Study Arms (1)

ARDS patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with ARDS

You may qualify if:

• 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

You may not qualify if:

• younger than 18 years old
• Patients or family members refused to participate in the study

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100029, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Transcriptome mRNA of blood and BALF

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Xu Huang, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 5, 2023
• Study Start: October 15, 2023
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: October 5, 2023

Record last verified: 2023-10

Locations

CN (1)