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

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

Effect of Transpulmonary Mechanical Power on the Prognosis of Patients With Severe Acute Respiratory Distress Syndrome Treated With Venovenous Extracorporeal Membrane Oxygenation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06062212
• Other study ID #: 2023-KE-926
• Status: Recruiting
• Start date: October 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: Beijing Chao Yang Hospital
• Contact: Yu Zhao, Dr.
• Phone: +8618601342030
• Email: xuanben1985[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Extracorporeal Membrane Oxygenation
• Mechanical Power
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Procedure:
• Transpulmonary pressure
Use transpulmonary pressure to guide ventilator setting in ECMO for severe ARDS patients.

Locations

Country	Name	City	State
China	Beijing Chao-Yang Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients successfully weaned from VV-ECMO	Weaning VV-ECMO more than 48 hours with stable oxygenation and no need to re-establish ECMO	After patients enrolled 60 days
Secondary	60-day mortality	Mortality rate at 60 days of VV-ECMO support	After patients enrolled 60 days