Electrical Impedance Tomography-Based Prognostic Model for ARDS

NCT06967207 | Recruiting

• 1 other identifier: EIT20250331
• Study Type: observational
• Target: 625
• Locations: 1 country
• Sites: 4

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.

Conditions

Acute Respiratory Distress Syndrome (ARDS); Ventilator-induced Lung Injury

Outcome Measures

Primary Outcomes (1)

• 28-day mortality rate

  From date of study enrollment (Day 0) until Day 28

Secondary Outcomes (7)

• ICU mortality rate

  From ICU admission to discharge, up to 24 weeks

• 60-day all-cause mortality rate

  60 days post-enrollment

• 90-day all-cause mortality rate

  90 days post-enrollment

• Duration of mechanical ventilation (days)

  From intubation to successful extubation, up to 28 days

• Ventilator-free days (VFDs) at 28 days

  28 days post-enrollment

Study Arms (2)

ARDS Patients for Training cohort

Training cohort

Other: Not applicable- observational study

ARDS Patients for Validation cohort

Validation cohort

Other: Not applicable- observational study

Interventions

Not applicable- observational study OTHER

Not applicable- observational study

ARDS Patients for Training cohort; ARDS Patients for Validation cohort

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Meet the new 2023 ARDS global definition;
• Age 18-80 years

You may not qualify if:

• 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

Sponsors & Collaborators

• XiaoJing Zou,MD: lead

Study Sites (4)

Department of Critical Care Medicine, Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

RECRUITING

Department of Critical Care Medicine, Renmin Hospital of Wuhan University

Wuhan, Hubei, China

RECRUITING

Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, China Department of

Wuhan, Hubei, China

RECRUITING

Department of Emergency, Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral whole blood samples will be collected and processed to isolate plasma, serum, and peripheral blood mononuclear cells (PBMCs). Processed samples (plasma, serum, PBMCs) will be stored at -80°C for future research. No DNA will be intentionally extracted or retained.

MeSH Terms

Conditions

Respiratory Distress Syndrome; Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Injury

Central Study Contacts

Xiaojing Zou Zou

CONTACT

84+13995518630; 249126734@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 13, 2025
• Study Start: April 15, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (4)