Early PP Monitored by EIT in Patients With ARDS

Not Applicable

Recruiting

• Conditions: Acute Respiratory Distress Syndrome
• Interventions: Procedure: EIT-guided mechanical ventilation strategy; Procedure: Lung protective ventilation group

• Registration Number: NCT05822869
• Lead Sponsor: Beijing Chao Yang Hospital

Brief Summary

Acute Respiratory Distress Syndrome (ARDS) is a syndrome characterized by respiratory distress and refractory hypoxemia caused by pulmonary and extra-pulmonary factors. Despite improvements in diagnosis and treatment in recent years, the mortality rate of severe ARDS is still around 40%. The distribution of lung lesions in ARDS patients is significantly gravity-dependent. Even with lung-protective ventilation strategies, tidal volume is concentrated in the ventral lung region, leading to ventilator-associated lung injury. Prone position ventilation can increase ventilation to the dorsal lung tissue and improve the ventilation-perfusion ratio, thus improving oxygenation. During prone position ventilation in ARDS patients, lung-protective ventilation strategies should be maintained, but with different respiratory mechanics from the supine position, requiring adjustment of ventilator parameters. Electrical Impedance Tomography (EIT) technology can be used for bedside monitoring of mechanically ventilated patients, providing real-time feedback on the patient's ventilation status and having great potential for clinical applications. Investigators believes that EIT monitoring during prone position ventilation in ARDS patients can individualize lung-protective ventilation strategies, minimize alveolar overdistension and collapse, improve the weaning success rate of invasive ventilation, and ultimately improve patient prognosis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-10
• Study First Submitted QC: 2023-04-10
• Study First Posted: 2023-04-21
• Study Start: 2023-05-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-16
• Primary Completion: 2025-04-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Age ≥ 18 years old；
2. Meets the diagnostic criteria for ARDS according to the 2012 Berlin definition；
3. Intubation with invasive mechanical ventilation time < 36 hours；
4. PaO2/FiO2 < 150mmHg.

Exclusion Criteria

1. Contraindication to the prone position;
2. Contraindication to the EIT;
3. Patients have received extracorporeal membrane oxygenation treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EIT guided group	EIT-guided mechanical ventilation strategy	During prone ventilation, the PEEP level is adjusted based on EIT monitoring.
Lung protective ventilation group	Lung protective ventilation group	Lung-protective ventilation strategy during prone positioning that continues the supine position.

Primary Outcome Measures

Name	Time	Method
28-day weaning rate from invasive mechanical ventilation	At 28 days of hospitalization.	After weaning from invasive mechanical ventilation lasting more than 48 hours, continuation with either high-flow nasal cannula (HFNC) or non-invasive ventilation (NIV).

Trial Locations

Locations (1)

Beijing Chao-Yang Hospital; 🇨🇳 Beijing, Beijing, China