New Lung Ventilation Strategies Guided by Transpulmonary Pressure in VV-ECMO for Severe ARDS

Study Overview
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Brief Summary
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Extracorporeal membrane oxygenation (ECMO) has been widely used in patients with severe acute respiratory distress syndrome (ARDS). But how to choose mechanical ventilation strategy is still not clear for severe ARDS patients supported by ECMO. Our previous work found that, compared to the traditional lung rest strategy, transpulmonary pressure guide new lung ventilation strategy can better maintain lung volume reduction lung collapse, atelectasis occurs. The severe ARDS patients receiving ECMO therapy were randomized divided into a new ventilation strategy group and the conventional ventilation strategy group. The new ventilation strategy is transpulmonary pressure guide ventilator setting method, and the conventional ventilation strategy is Extracorporeal Life Support Organization (ELSO) guide ventilation method. Compare the difference between the two groups of patients in lung injury, and explore the lung protection mechanism of new lung ventilation strategies guided by transpulmonary pressure. Our research group considered that transpulmonary pressure guide new lung ventilation strategy can provide more effective lung protection. And it will be further used in clinical work.

Conditions
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Respiratory Distress Syndrome, Adult

Intervention / Treatment
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* Device: New lung ventilation strategy
* Device: Conventional ventilation strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ARDS cause reversible; Pure oxygen is given, but PaO2/FiO2<80; P(A-a)O2>600mmHg; Murray score≥3.0; pH<7.2; Exclusion Criteria: peak inspiratory pressure>30cmH2O; high FiO2>0.8; ventilation>7 days; contraindication to heparinization; non-reversible central nervous system injury chronic disease with a short life expectancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New Strategy<br>New Strategy: use transpulmonary pressure guide new lung ventilation strategy in ECMO for severe ARDS patients | Device: New lung ventilation strategy<br>* New ventilation strateg: pressure assist control mode; inspiratory pressure was lowered to keep Ppeak less than 25cmH2O; set the PEEP at such a level that expiratory transpulmonary pressure stays between 0 and 5 cmH2O; respiratory rate of 10 breaths per minute; FiO2 less than 0.5.<br>|
| Other: Conventional Strategy<br>Conventional Strategy: use conventional ventilation strategy (ELSO guide ventilation strategy) in ECMO for severe ARDS patients | Device: Conventional ventilation strategy<br>* Conventional ventilation strategy: pressure assist control mode; keep the Ppeak between 20 and 25 cmH2O; set PEEP between 10 and 15 cmH2O; respiratory rate of 10 breaths per minute; FiO2 less than 0.5.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion weaned from VV-ECMO | Respiratory failure was alleviated and then ECMO withdrawal could be considered | After patients randomized grouping 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 60-day mortality | Mortality after patients randomized grouping 60 days | After patients randomized grouping 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extracorporeal Membrane Oxygenation