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

Respiratory Distress Syndrome, Adult Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02439151
• Other study ID #: 2014-KE-143
• Status: Completed
• Phase: N/A
• Start date: May 1, 2015
• Est. completion date: June 25, 2020

Study information

• Verified date: June 2020
• Source: Beijing Chao Yang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: June 25, 2020
• Est. primary completion date: June 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• New lung ventilation strategy
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.
• Conventional ventilation strategy
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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Rui Wang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion weaned from VV-ECMO	Respiratory failure was alleviated and then ECMO withdrawal could be considered	After patients randomized grouping 60 days
Secondary	60-day mortality	Mortality after patients randomized grouping 60 days	After patients randomized grouping 60 days