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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02439151

Enrollment

104

Registered

2015-05-08

Start date

2015-05-01

Completion date

2020-06-25

Last updated

2020-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome, Adult

Keywords

Extracorporeal Membrane Oxygenation

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.

Interventions

DEVICENew 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.

DEVICEConventional 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
60-day mortality	After patients randomized grouping 60 days	Mortality after patients randomized grouping 60 days

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026