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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06062212
Other study ID # 2023-KE-926
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2023
Est. completion date December 31, 2024

Study information

Verified date October 2023
Source Beijing Chao Yang Hospital
Contact Yu Zhao, Dr.
Phone +8618601342030
Email xuanben1985@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Beijing Chao-Yang Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 60-day mortality Mortality rate at 60 days of VV-ECMO support After patients enrolled 60 days
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