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

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ClinicalTrials.gov Identifier: NCT02439151
Recruitment Status : Recruiting
First Posted : May 8, 2015
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Rui Wang, Beijing Chao Yang Hospital

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.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome, Adult Device: New lung ventilation strategy Device: Conventional ventilation strategy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Actual Study Start Date : May 1, 2015
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
Experimental: New Strategy
New Strategy: use transpulmonary pressure guide new lung ventilation strategy in ECMO for severe ARDS patients
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 Strategy
Conventional Strategy: use conventional ventilation strategy (ELSO guide ventilation strategy) in ECMO for severe ARDS patients
Device: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  1. 60-day mortality [ Time Frame: After patients randomized grouping 60 days ]
    Mortality after patients randomized grouping 60 days



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02439151


Contacts
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Contact: Rui Wang, doctor +86 18601342030 xuanben1985@163.com

Locations
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China, Beijing
Beijing Chao-Yang Hospital Recruiting
Beijing, Beijing, China, 100020
Contact: Rui Wang, MD    +8618601342030    xuanben1985@163.com   
Sponsors and Collaborators
Rui Wang
Investigators
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Principal Investigator: Bing Sun, master Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China

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Responsible Party: Rui Wang, Principal Investigator, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier: NCT02439151     History of Changes
Other Study ID Numbers: 2014-KE-143
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Keywords provided by Rui Wang, Beijing Chao Yang Hospital:
Extracorporeal Membrane Oxygenation
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury