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

NCT06062212 | Recruiting DMC

• 1 other identifier: 2023-KE-926
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Distress Syndrome; Extracorporeal Membrane Oxygenation; Mechanical Power; Transpulmonary Mechanical Power

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 60-day mortality

  After patients enrolled 60 days

Study Arms (1)

Transpulmonary pressure group

Procedure: Transpulmonary pressure

Interventions

Transpulmonary pressure PROCEDURE

Use transpulmonary pressure to guide ventilator setting in ECMO for severe ARDS patients.

Transpulmonary pressure group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Severe ARDS patients treated with VV-ECMO

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

Study Sites (1)

Beijing Chao-Yang Hospital

Beijing, Beijing Municipality, 100020, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Arterial blood gas analysis, blood routine, liver and kidney function, coagulation, and BNP

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Rui Wang, Dr.

  Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China

  STUDY DIRECTOR

Central Study Contacts

Yu Zhao, Dr.

CONTACT

+8618601342030; xuanben1985@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 2, 2023
• Study Start: October 1, 2023
• Primary Completion: December 30, 2025
• Study Completion: December 31, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)