Research on ARDS patients requiring invasive mechanical ventilation

Clinical Empirical Research of ARDS

This study is trying to learn more about patients with severe Acute Respiratory Distress Syndrome who need breathing machines by looking at their health data and samples to see how their condition changes.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Chinese PLA General Hospital (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05922826 on ClinicalTrials.gov

What this trial studies

This observational study focuses on patients diagnosed with Acute Respiratory Distress Syndrome (ARDS) who require invasive mechanical ventilation. It aims to collect clinical data and prognosis while analyzing biological samples such as blood and bronchoalveolar lavage fluid (BALF) to understand changes in their condition. The study specifically targets patients who meet the Berlin definition of ARDS and have a PaO2/FiO2 ratio of 200 mmHg or less. The data collected will help in understanding the clinical outcomes and potential prognostic factors in this patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 18 to 85 who meet the Berlin criteria for ARDS and require invasive mechanical ventilation.

Not a fit: Patients with severe comorbidities, such as intracranial hypertension or severe hemodynamic instability, as well as those outside the age range or pregnant, may not benefit from this study.

Why it matters

Potential benefit: If successful, this research could lead to improved understanding and management of ARDS in patients requiring mechanical ventilation.

How similar studies have performed: Other studies focusing on ARDS have shown promise in understanding the condition, but this specific observational approach may provide novel insights.

Eligibility criteria

Inclusion Criteria:

1. Patients who meet the Berlin definition of ARDS and require invasive mechanical ventilation. ARDS diagnostic criteria: according to the Berlin definition, Chest radiograph shows patchy shadows in the lungs; Respiratory failure cannot be completely caused by heart failure or excessive fluid infusion
2. ARDS onset ≤ 3 days when included in the study
3. Patient PaO2/FiO2 ≤ 200mmHg when included in the study

Exclusion Criteria:

* 1\) Patients with intracranial hypertension, pleural fistula, pneumothorax, HIV, HBV, HCV

  2\) Age\>85 years old or\<18 years old

  3\) Pregnant patients

  4\) Severe hemodynamic instability (vasopressor increase\>30% in the first 6 hours, or Norepinephrine\>0.5 mg kg/min)

  5\) Patients unable to perform EIT ventilation and/or perfusion testing (unable to perform internal jugular vein catheterization, Hypernatremia, chest malformation, active implant device, unstable spinal injury or fracture, skin lesions opposite the EIT monitoring area)

  6\) Patients with abnormal esophageal anatomical structure and inability to indwelling gastric tubes

  7\) Disagreement for inclusion in this study

Where this trial is running

Beijing, Beijing Municipality

• Department of Pulmonary and Critical Care Medicine, Chinese PLA General Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Lin Wang, doctor

Conditions: Invasive Mechanical Ventilation ARDS