Actively Recruiting
Electrical Impedance Tomography-Based Prognostic Model for ARDS: A Multicenter, Prospective, Observational Study
Led by XiaoJing Zou,MD · Updated on 2025-05-13
625
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a multicenter, prospective observational study to develop and validate a prognostic model using Electrical Impedance Tomography (EIT) for patients with Acute Respiratory Distress Syndrome (ARDS). The study focuses on understanding the pathophysiological features of ARDS and the causes of ventilator-induced lung injury, aiming to create a model that can reveal lung injury and heterogeneity. This model will help classify patient risk and guide personalized treatment approaches. Participants with ARDS will be divided into two groups: a training cohort and a validation cohort. The study does not involve any experimental treatments but observes patients under usual care to collect data related to lung function and injury through EIT. This observational approach allows researchers to analyze the progression and characteristics of lung damage without altering standard treatment. During the study, participants will be monitored for various outcomes including the 28-day mortality rate, ICU and hospital mortality rates over different time frames, duration of mechanical ventilation, ventilator-free days, and lengths of stay in ICU and hospital. These measures will help evaluate the prognostic model's accuracy. The study will track patients from enrollment through 28 days and up to 24 weeks for certain outcomes, supporting long-term observation of clinical status and recovery.
CONDITIONS
Brief Title
Electrical Impedance Tomography-Based Prognostic Model for ARDS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet the new 2023 ARDS global definition
- Age 18-80 years
You will not qualify if you...
- Expected death within 24 hours of screening
- Metastatic cancer (active malignancy with distant metastases)
- Severe psychiatric disorders
- Pregnancy or postpartum status
- Pneumothorax or moderate to large pleural effusion without adequate drainage
- Chronic respiratory failure
- Patients with pulmonary embolism or pulmonary hypertension
- Heart failure patients: EF <50% or NYHA class III or IV
- Patient/family refusal to participate
- Participation in another interventional trial within 3 months prior to enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 24 hours
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From enrollment up to 28 days
Participants undergo assessments and measurements related to their ARDS condition.
Daily assessments during ICU stay up to 28 days
Duration - Up to 24 weeks post-enrollment
Participants are monitored for mortality and clinical outcomes following ICU admission and hospital discharge.
Follow-up assessments up to 24 weeks
Trial Site Locations
Total: 4 locations
1
Department of Critical Care Medicine, Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Actively Recruiting
2
Department of Critical Care Medicine, Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Actively Recruiting
3
Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, China Department of
Wuhan, Hubei, China
Actively Recruiting
4
Department of Emergency, Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
X
Xiaojing Zou Zou
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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