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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06062212
Enrollment
100
Registered
2023-10-02
Start date
2023-10-01
Completion date
2025-12-31
Last updated
2025-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

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

Sponsors

Beijing Chao Yang Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Patients successfully weaned from VV-ECMOAfter patients enrolled 60 daysWeaning VV-ECMO more than 48 hours with stable oxygenation and no need to re-establish ECMO

Secondary

MeasureTime frameDescription
60-day mortalityAfter patients enrolled 60 daysMortality rate at 60 days of VV-ECMO support

Countries

China

Contacts

Primary ContactYu Zhao, Dr.
xuanben1985@163.com+8618601342030

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026