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Clinical Trials/NCT06062212
NCT06062212
Recruiting
Not Applicable

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

Beijing Chao Yang Hospital1 site in 1 country100 target enrollmentOctober 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Respiratory Distress Syndrome
Sponsor
Beijing Chao Yang Hospital
Enrollment
100
Locations
1
Primary Endpoint
Patients successfully weaned from VV-ECMO
Status
Recruiting
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2023
End Date
December 31, 2025
Last Updated
10 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Beijing Chao Yang Hospital
Responsible Party
Principal Investigator
Principal Investigator

Rui Wang

Principal Investigator

Beijing Chao Yang Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Patients successfully weaned from VV-ECMO

Time Frame: After patients enrolled 60 days

Weaning VV-ECMO more than 48 hours with stable oxygenation and no need to re-establish ECMO

Secondary Outcomes

  • 60-day mortality(After patients enrolled 60 days)

Study Sites (1)

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