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

NCT ID: NCT06062212

Last Updated: 2025-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Transpulmonary pressure group

Transpulmonary pressure

Intervention Type PROCEDURE

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

Interventions

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Transpulmonary pressure

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Chao Yang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rui Wang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rui Wang, Dr.

Role: STUDY_DIRECTOR

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

Locations

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Beijing Chao-Yang Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yu Zhao, Dr.

Role: CONTACT

+8618601342030

Facility Contacts

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Rui Wang, MD

Role: primary

+8618601342030

Other Identifiers

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2023-KE-926

Identifier Type: -

Identifier Source: org_study_id

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