Effect of Transpulmonary MP on Prognosis of Patients with Severe ARDS Treated with VV-ECMO

Recruiting

• Conditions: Extracorporeal Membrane Oxygenation; Mechanical Power; Acute Respiratory Distress Syndrome; Transpulmonary Mechanical Power
• Interventions: Procedure: Transpulmonary pressure

• Registration Number: NCT06062212
• Lead Sponsor: Beijing Chao Yang Hospital

Brief Summary

Venovenous extracorporeal membrane oxygenation (VV-ECMO) is a salvage treatment for severe acute respiratory distress syndrome (ARDS). With the large-scale implementation of VV-ECMO in critical care medicine departments in China, significant progress has been made in treating severe ARDS. However, the patient mortality rate remains high. The pathophysiological essence of ARDS is an imbalance between the body's oxygen supply and demand, causing tissue and cell hypoxia, organ dysfunction, and even death. The VV-ECMO treatment process still requires mechanical ventilation assistance. However, inappropriate mechanical ventilation settings can lead to ventilator-related lung injury (VILI). In recent years, mechanical power has gradually attracted everyone's attention and is considered the cause of VILI. The transpulmonary mechanical power is more accurate to the energy directly performed to the lung tissue. Transpulmonary mechanical energy has a specific value in judging the prognosis of mechanically ventilated patients, but its clinical significance in treating patients with VV-ECMO is unclear. This study aimed to explore the value of transpulmonary mechanical power in predicting the prognosis of patients with severe ARDS patients treated with VV-ECMO.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-25
• Study First Submitted QC: 2023-09-25
• Study Start: 2023-10-01
• Study First Posted: 2023-10-02
• Status Verified: 2024-10
• Last Update Submitted: 2024-11-02
• Last Update Posted: 2024-11-05
• Primary Completion: 2025-05-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Meet the diagnostic criteria of Berlin's definition for ARDS;
2. Receiving VV-ECMO support.

Exclusion Criteria

1. Patients had been on high pressure (Ppeak >35 cm H2O) and a high fraction of inspired oxygen (FiO2>0.8) ventilation for >7 days;
2. Patients had a contraindication to heparinization;
3. Patients had an irreversible neurological injury;
4. Patients had severe chronic lung disease with life expectancy <6 months.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transpulmonary pressure group	Transpulmonary pressure	-

Primary Outcome Measures

Name	Time	Method
Patients successfully weaned from VV-ECMO	After patients enrolled 60 days	Weaning VV-ECMO more than 48 hours with stable oxygenation and no need to re-establish ECMO

Secondary Outcome Measures

Name	Time	Method
60-day mortality	After patients enrolled 60 days	Mortality rate at 60 days of VV-ECMO support

Trial Locations

Locations (1)

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