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Recruiting NCT06967207

Electrical Impedance Tomography-Based Prognostic Model for ARDS

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Not applicable- observational study.
Who it may be relevant to
Registry conditions: Acute Respiratory Distress Syndrome (ARDS), Ventilator-induced Lung Injury. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Electrical Impedance Tomography-Based Prognostic Model for ARDS: A Multicenter, Prospective, Observational Study

Overview

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.

Interventions

  • Other Not applicable- observational study
    Not applicable- observational study

Primary outcome measures

  • 28-day mortality rate [Time frame: From date of study enrollment (Day 0) until Day 28]
Secondary outcome measures (7)
  • ICU mortality rate [Time frame: From ICU admission to discharge, up to 24 weeks]
  • 60-day all-cause mortality rate [Time frame: 60 days post-enrollment]
  • 90-day all-cause mortality rate [Time frame: 90 days post-enrollment]
  • Duration of mechanical ventilation (days) [Time frame: From intubation to successful extubation, up to 28 days]
  • Ventilator-free days (VFDs) at 28 days [Time frame: 28 days post-enrollment]
  • ICU length of stay (days) [Time frame: From ICU admission to discharge, up to 24 weeks]
  • Hospital length of stay [Time frame: From hospital admission to discharge, up to 24 weeks]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 4 centers
  • Department of Critical Care Medicine, Guangdong Provincial People's Hospital — Guangzhou
  • Department of Critical Care Medicine, Renmin Hospital of Wuhan University — Wuhan
  • Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong Uni — Wuhan
  • Department of Emergency, Zhongshan Hospital, Fudan University — Shanghai

Identifiers

NCT: NCT06967207 · EIT20250331

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗