Clinical trial NCT06069466: Epidemiological Characteristics and Prediction System of Acute Respiratory Distress Syndrome
Official title: Epidemiological Characteristics and Prediction System of Acute Respiratory Distress Syndrome in China RICUs-CHARDS II Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Acute Respiratory Distress Syndrome
Keywords: ARDS; mortality; incidence; prognosis; predictive model; AI
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with ARDS

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.


Eligibility criteria: 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

Primary outcomes:
measure: the prognosis of ARDS patients
timeFrame: from 28d to 1 year
Secondary outcomes:
measure: Incidence of ARDS in ICUs
timeFrame: 2 years
measure: Length of hospital stay in ARDS patients
timeFrame: during hospitalization
measure: VFDs within 28 days
timeFrame: 28 days
measure: Long-term quality of life and long-term lung function
timeFrame: 1 year
measure: Rates of mechanical ventilation strategies are consistent with guidelines rates of rates of mechanical ventilation strategies consistent with guidelines
timeFrame: during hospitalization
measure: Survival risk factors in hospitalized ARDS patients
timeFrame: during hospitalization
measure: Risk factors for ARDS complications
timeFrame: during hospitalization
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital
state: Beijing
Study officials:
affiliation: Department of Respiratory and Critical Care Medicine, China-Japan Friendship Hospital
name: Xu Huang, PhD
role: PRINCIPAL_INVESTIGATOR
References: