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

Not Applicable

Completed

• Conditions: Respiratory Distress Syndrome, Adult
• Interventions: Device: New lung ventilation strategy; Device: Conventional ventilation strategy

• Registration Number: NCT02439151
• Lead Sponsor: Rui Wang

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-01
• Study First Submitted: 2015-05-01
• Study First Submitted QC: 2015-05-06
• Study First Posted: 2015-05-08
• Status Verified: 2020-06
• Primary Completion: 2020-06-25
• Study Completion: 2020-06-25
• Last Update Submitted: 2020-06-29
• Last Update Posted: 2020-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
New Strategy	New lung ventilation strategy	New Strategy: use transpulmonary pressure guide new lung ventilation strategy in ECMO for severe ARDS patients
Conventional Strategy	Conventional ventilation strategy	Conventional Strategy: use conventional ventilation strategy (ELSO guide ventilation strategy) in ECMO for severe ARDS patients

Primary Outcome Measures

Name	Time	Method
Proportion weaned from VV-ECMO	After patients randomized grouping 60 days	Respiratory failure was alleviated and then ECMO withdrawal could be considered

Secondary Outcome Measures

Name	Time	Method
60-day mortality	After patients randomized grouping 60 days	Mortality after patients randomized grouping 60 days

Trial Locations

Locations (1)

Beijing Chao-Yang Hospital; 🇨🇳 Beijing, Beijing, China