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NCT Number: NCT06062212

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Chao-Yang Hospital

Beijing, Beijing Municipality, 100020, China

Location status: Recruiting

Location contact

Rui Wang, MD

CONTACT

[email protected]

+8618601342030

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transpulmonary pressure

Procedure

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

Primary outcomes

  1. 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

  1. 60-day mortality

    Time frame: After patients enrolled 60 days

    Mortality rate at 60 days of VV-ECMO support

Study contacts

Contact information is provided by the study sponsor or research team.

Yu Zhao, Dr.

CONTACT

[email protected]

+8618601342030

Sponsors and collaborators

Lead sponsor

Beijing Chao Yang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 2, 2023
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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