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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Extracorporeal Membrane Oxygenation; Acute Respiratory Distress Syndrome; Mechanical Power; Transpulmonary Mechanical Power
• Intervention / Treatment: Procedure: Transpulmonary pressure

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Yu Zhao, Dr.; Phone Number: +8618601342030; Email: xuanben1985@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100020
      • Recruiting
      • Beijing Chao-Yang Hospital
      • Contact: Rui Wang, MD; Phone Number: +8618601342030; Email: xuanben1985@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Severe ARDS patients treated with VV-ECMO

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Transpulmonary pressure group	Procedure: Transpulmonary pressure; Use transpulmonary pressure to guide ventilator setting in ECMO for severe ARDS patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
60-day mortality	Mortality rate at 60 days of VV-ECMO support	After patients enrolled 60 days

Collaborators and Investigators

• Sponsor: Beijing Chao Yang Hospital
• Investigators: Study Director: Rui Wang, Dr., Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 25, 2023
• First Submitted That Met QC Criteria: September 25, 2023
• First Posted (Actual): October 2, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: July 2, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease; Lung Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 2023-KE-926

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No