Respiratory Distress Syndrome, AdultNCT02439151
New Lung Ventilation Strategies Guided by Transpulmonary Pressure in VV-ECMO for Severe ARDS
A study testing New lung ventilation strategy and Conventional ventilation strategy in people with Respiratory Distress Syndrome, Adult, run by Rui Wang at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Respiratory Distress Syndrome, Adult
- What is being tested?
- New lung ventilation strategy and Conventional ventilation strategy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2015to 25 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ARDS cause reversible;
- Pure oxygen is given, but PaO2/FiO2<80;
- P(A-a)O2>600mmHg;
- Murray score≥3.0;
- pH<7.2;
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Respiratory Distress Syndrome, Adult
- Being tested
- New lung ventilation strategy, Conventional ventilation strategy
- Keywords
- Extracorporeal Membrane Oxygenation
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New lung ventilation strategyDevice
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 strategyDevice
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 group | Role | What they receive |
|---|---|---|
| New Strategy | Experimental | New Strategy: use transpulmonary pressure guide new lung ventilation strategy in ECMO for severe ARDS patients Receives: Device: New lung ventilation strategy |
| Conventional Strategy | Other | Conventional Strategy: use conventional ventilation strategy (ELSO guide ventilation strategy) in ECMO for severe ARDS patients Receives: Device: Conventional ventilation strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion weaned from VV-ECMO
Respiratory failure was alleviated and then ECMO withdrawal could be considered
Measured: After patients randomized grouping 60 days
Secondary outcomes (1)
60-day mortality
Mortality after patients randomized grouping 60 days
Measured: After patients randomized grouping 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study start1 May 2015
- Primary completion25 Jun 2020
- Study completion25 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rui Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rui Wang, Beijing Chao Yang Hospital
- Investigators
- Bing Sun, master, Principal investigator, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02439151
- Sponsor's protocol ID
- 2014-KE-143
- Status last verified
- Jun 2020
- First submitted
- 1 May 2015
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Lung Ventilation Strategies Guided by Transpulmonary Pressure in VV-ECMO for Severe ARDS
- ClinicalTrials.gov ID
- NCT02439151
- Acronym / sponsor ID
- 2014-KE-143
- Conditions
- Respiratory Distress Syndrome, Adult
- Keywords
- Extracorporeal Membrane Oxygenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Rui WangUniversity, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- 25 Jun 2020 (actual)
- Study completion
- 25 Jun 2020 (actual)
- First posted
- 8 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New Strategy | Experimental | Device: New lung ventilation strategyNew Strategy: use transpulmonary pressure guide new lung ventilation strategy in ECMO for severe ARDS patients |
| Conventional Strategy | Other | Device: Conventional ventilation strategyConventional Strategy: use conventional ventilation strategy (ELSO guide ventilation strategy) in ECMO for severe ARDS patients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ARDS cause reversible;
- Pure oxygen is given, but PaO2/FiO2<80;
- P(A-a)O2>600mmHg;
- Murray score≥3.0;
- pH<7.2;
Key exclusion criteria (6 listed)
- peak inspiratory pressure>30cmH2O;
- high FiO2>0.8;
- ventilation>7 days;
- contraindication to heparinization;
- non-reversible central nervous system injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New lung ventilation strategyNew 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. | Device | New Strategy |
| Conventional ventilation strategyConventional 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. | Device | Conventional Strategy |
Primary outcome
Proportion weaned from VV-ECMO
Time frame: After patients randomized grouping 60 days
Respiratory failure was alleviated and then ECMO withdrawal could be considered
1 secondary outcome
60-day mortality
Time frame: After patients randomized grouping 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bing Sun, master principal investigator
Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New lung ventilation strategy and Conventional ventilation strategy in people with Respiratory Distress Syndrome, Adult, run by Rui Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion weaned from VV-ECMO (time frame: After patients randomized grouping 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2020.