Back to resultsNew Lung Ventilation Strategies Guided by Transpulmonary Pressure in VV-ECMO for Severe ARDS
Primary Purpose
Respiratory Distress Syndrome, Adult
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
New lung ventilation strategy
Conventional ventilation strategy
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Distress Syndrome, Adult focused on measuring Extracorporeal Membrane Oxygenation
Eligibility 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
Sites / Locations
- Beijing Chao-Yang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
New Strategy
Conventional Strategy
Arm Description
New Strategy: use transpulmonary pressure guide new lung ventilation strategy in ECMO for severe ARDS patients
Conventional Strategy: use conventional ventilation strategy (ELSO guide ventilation strategy) in ECMO for severe ARDS patients
Outcomes
Primary Outcome Measures
Proportion weaned from VV-ECMO
Respiratory failure was alleviated and then ECMO withdrawal could be considered
Secondary Outcome Measures
60-day mortality
Mortality after patients randomized grouping 60 days
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02439151
Brief Title
New Lung Ventilation Strategies Guided by Transpulmonary Pressure in VV-ECMO for Severe ARDS
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2015 (Actual)
Primary Completion Date
June 25, 2020 (Actual)
Study Completion Date
June 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rui Wang
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Adult
Keywords
Extracorporeal Membrane Oxygenation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
New Strategy
Arm Type
Experimental
Arm Description
New Strategy: use transpulmonary pressure guide new lung ventilation strategy in ECMO for severe ARDS patients
Arm Title
Conventional Strategy
Arm Type
Other
Arm Description
Conventional Strategy: use conventional ventilation strategy (ELSO guide ventilation strategy) in ECMO for severe ARDS patients
Intervention Type
Device
Intervention Name(s)
New lung ventilation strategy
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Conventional ventilation strategy
Intervention Description
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 Measure Information:
Title
Proportion weaned from VV-ECMO
Description
Respiratory failure was alleviated and then ECMO withdrawal could be considered
Time Frame
After patients randomized grouping 60 days
Secondary Outcome Measure Information:
Title
60-day mortality
Description
Mortality after patients randomized grouping 60 days
Time Frame
After patients randomized grouping 60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bing Sun, master
Organizational Affiliation
Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Chao-Yang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
12. IPD Sharing Statement
Learn more about this trial
New Lung Ventilation Strategies Guided by Transpulmonary Pressure in VV-ECMO for Severe ARDS
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