Personalized ventilation strategies for patients with acute respiratory distress syndrome

Personalized Ventilatory Strategy Based on Ventilation-perfusion Mismatch and Lung Recruitability in Moderate-to-severe ARDS Patients

This study is testing how different breathing support levels and body positions can help improve lung function in patients with severe acute respiratory distress syndrome.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Zhongda Hospital (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06430554 on ClinicalTrials.gov

What this trial studies

This observational study investigates how different levels of positive end-expiratory pressure (PEEP) and body positions affect lung ventilation-perfusion matching in patients with moderate-to-severe acute respiratory distress syndrome (ARDS). By utilizing electrical impedance tomography (EIT), the study aims to assess the impact of low and high PEEP in both supine and prone positions on lung function. The research will also explore the relationship between changes in ventilation-perfusion patterns and the lung's ability to be recruited for better oxygenation. Participants will undergo controlled ventilation while being monitored for various respiratory and hemodynamic parameters.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 85 with moderate-to-severe ARDS who require invasive mechanical ventilation.

Not a fit: Patients over 85 years old, pregnant women, or those with severe hemodynamic instability or contraindications to EIT monitoring may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved ventilation strategies that enhance oxygenation and reduce lung injury in ARDS patients.

How similar studies have performed: While the specific approach of this study may be novel, previous studies have shown that optimizing PEEP and body position can improve outcomes in ARDS patients.

Eligibility criteria

Inclusion Criteria:

1. age ≥18 years
2. Moderate-to-severe ARDS as per the 2023 ESICM definition
3. Undergoing invasive mechanical ventilation
4. Planned prone position based on the attending physicians' decisions
5. Signed informed consent

Exclusion Criteria:

1. age ≥85 years
2. Pregnancy
3. Severe hemodynamic instability (\> 30% increase in vasopressors in the last 6 hours or norepinephrine \> 0.5 µg/kg/min)
4. Clinically suspected elevated intracranial pressure (\>18 mm Hg)
5. Bronchopleural fistula
6. Contraindication to EIT monitoring (e.g. burns, pacemaker, thoracic wounds limiting electrode belt placement)
7. Severe hypernatremia (\>170mmol/L)
8. Re-admission of patients already enrolled in this study, or patients who are participating in other studies

Where this trial is running

Nanjing, Jiangsu

• Zhongda Hospital, Southeast University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Fengmei Guo, PhD, MD

Conditions Respiratory Distress Syndrome; Positive-Pressure Respiration; Mechanical Ventilation; Acute respiratory distress syndrome; Positive end expiratory pressure; Prone Position; Ventilation/perfusion matching.