Clinical trial NCT06967207: Electrical Impedance Tomography-Based Prognostic Model for ARDS
Official title: Electrical Impedance Tomography-Based Prognostic Model for ARDS: A Multicenter, Prospective, Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Respiratory Distress Syndrome (ARDS)
Ventilator-induced Lung Injury
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 625
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a prospective, multicenter, observational cohort study that will enroll adult patients (aged 18-80 years) diagnosed with acute respiratory distress syndrome (ARDS) per the new 2023 ARDS global definition.

Brief summary: This multicenter, prospective, observational study aims to develop and validate an EIT-based prognostic model for ARDS. By focusing on the pathophysiological characteristics of ARDS and the causes of ventilator-induced lung injury, the investigators intend to establish a prognostic model that reveals lung injury and heterogeneity, enabling risk stratification and guiding individualized treatment.


Eligibility criteria: Inclusion Criteria:

1. Meet the new 2023 ARDS global definition;
2. Age 18-80 years

Exclusion Criteria:

1. Expected death within 24 hours of screening;
2. Metastatic cancer (active malignancy with distant metastases);
3. Severe psychiatric disorders;
4. Pregnancy or postpartum status;
5. Pneumothorax or moderate to large pleural effusion without adequate drainage;
6. Chronic respiratory failure;
7. Patients with pulmonary embolism or pulmonary hypertension;
8. Heart failure patients: EF \<50% or NYHA class III or IV;
9. Patient/family refusal to participate;
10. Participation in another interventional trial within 3 months prior to enrollment

Primary outcomes:
measure: 28-day mortality rate
timeFrame: From date of study enrollment (Day 0) until Day 28
Secondary outcomes:
measure: ICU mortality rate
timeFrame: From ICU admission to discharge, up to 24 weeks
measure: 60-day all-cause mortality rate
timeFrame: 60 days post-enrollment
measure: 90-day all-cause mortality rate
timeFrame: 90 days post-enrollment
measure: Duration of mechanical ventilation (days)
timeFrame: From intubation to successful extubation, up to 28 days
measure: Ventilator-free days (VFDs) at 28 days
timeFrame: 28 days post-enrollment
measure: ICU length of stay (days)
timeFrame: From ICU admission to discharge, up to 24 weeks
measure: Hospital length of stay
timeFrame: From hospital admission to discharge, up to 24 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Critical Care Medicine, Guangdong Provincial People's Hospital
state: Guangdong
city: Wuhan
country: China
facility: Department of Critical Care Medicine, Renmin Hospital of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, China Department of
state: Hubei
city: Shanghai
country: China
facility: Department of Emergency, Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
References: