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Completed

NCT Number: NCT02439151

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Chao-Yang Hospital

Beijing, Beijing Municipality, 100020, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

New lung ventilation strategy

Device

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

Device

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.

Primary outcomes

  1. Proportion weaned from VV-ECMO

    Time frame: After patients randomized grouping 60 days

    Respiratory failure was alleviated and then ECMO withdrawal could be considered

Secondary outcomes

  1. 60-day mortality

    Time frame: After patients randomized grouping 60 days

    Mortality after patients randomized grouping 60 days

Sponsors and collaborators

Lead sponsor

Rui Wang

Other

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
May 8, 2015
Registry last updated
Jul 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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