COVID-19NCT04359251
Different PEEP Settings of COVID-19 Induced ARDS
A study testing Gas exchanges at different PEEP, lung mechanics at different PEEP and Hemodynamics changes at different PEEP in people with COVID-19 and Mechanical Ventilation Pressure High, run by Southeast University, China at 1 site in China.
Trial summary
This was a multi-center prospective study. All consecutive severe cases of COVID-19 whose PO2/FiO2<300mmHg with invasive ventilation admitted to 5 fixed-point receive COVID-19 patients hospitals in Wuhan from 5 March to 15 March 2020 were included. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19, Mechanical Ventilation Pressure High, Acute Respiratory Distress Syndrome
- What is being tested?
- Gas exchanges at different PEEP, lung mechanics at different PEEP and Hemodynamics changes at different PEEP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 5 Mar 2020to 25 Mar 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COVID-19 patients with mechanical ventilation
- PO2/FIO2<300mmHg
- ages>18 years
Who cannot join
- pneumothorax
- pregnant
- hemodynamics is unstable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Avoiding High PEEP in COVID-19 Induced ARDS: a Multi-center Study
This was a multi-center prospective study. All consecutive severe cases of COVID-19 whose PO2/FiO2<300mmHg with invasive ventilation admitted to 5 fixed-point receive COVID-19 patients hospitals in Wuhan from 5 March to 15 March 2020 were included. Epidemiological, clinical data, lung mechanics, artery blood gas test and hemodynamics at three methods to titrate PEEP, optimizing oxygenation, optimizing compliance, ARDSnet. The study was approved by the Ethics Committee of Zhongda Hsopital, Southeast University.
Read the detailed description
After PEEP titration, PEEP settings could be set by optimizing oxygenation, optimizing compliance, ARDSnet.
- Being tested
- Gas exchanges at different PEEP, lung mechanics at different PEEP, Hemodynamics changes at different PEEP
- Keywords
- ARDS, COVID-19, mechanical ventilation, PEEP
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gas exchanges at different PEEPOther
Gas exchanges measurement at different PEEP
lung mechanics at different PEEPOther
lung mechanics measurement at different PEEP
Hemodynamics changes at different PEEPOther
Hemodynamics changes measurement at different PEEP
| Study group | Role | What they receive |
|---|---|---|
| Optimizing oxygenation | Experimental | Best oxygenation during PEEP titration Receives: Other: Gas exchanges at different PEEP |
| Optimizing compliance | Experimental | Best compliance during PEEP titration Receives: Other: lung mechanics at different PEEP |
| ARDSnet | Experimental | PEEP settings according to ARDSnet table Receives: Other: Hemodynamics changes at different PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory system compliance improvement
the respiratory system compliance was compared among three groups
Measured: 20 minutes
Secondary outcomes (1)
Gas echanges improvement
P/Fwere compared among three groups
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start5 Mar 2020
- Primary completion25 Mar 2020
- Study completion25 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Pan, Southeast University, China
- Investigators
- Chun C Pan, Study director, Zhongda hospital, Southeast University, Jiangsu, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359251
- Sponsor's protocol ID
- COVID-19 PEEP titration
- Status last verified
- Apr 2020
- First submitted
- 13 Apr 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pan C, Lu C, She X, Ren H, Wei H, Xu L, Huang Y, Xia J, Yu Y, Chen L, Du B, Qiu H. Evaluation of Positive End-Expiratory Pressure Strategies in Patients With Coronavirus Disease 2019-Induced Acute Respiratory Distress Syndrome. Front Med (Lausanne). 2021 Jul 20;8:637747. doi: 10.3389/fmed.2021.637747. eCollection 2021.
PubMed 34355001
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avoiding High PEEP in COVID-19 Induced ARDS: a Multi-center Study
- ClinicalTrials.gov ID
- NCT04359251
- Acronym / sponsor ID
- COVID-19 PEEP titration
- Keywords
- ARDS, COVID-19, mechanical ventilation, PEEP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 25 Mar 2020 (actual)
- Study completion
- 25 Mar 2020 (actual)
- First posted
- 24 Apr 2020 (actual)
- 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.
This was a multi-center prospective study. All consecutive severe cases of COVID-19 whose PO2/FiO2<300mmHg with invasive ventilation admitted to 5 fixed-point receive COVID-19 patients hospitals in Wuhan from 5 March to 15 March 2020 were included. Epidemiological, clinical data, lung mechanics, artery blood gas test and hemodynamics at three methods to titrate PEEP, optimizing oxygenation, optimizing compliance, ARDSnet. The study was approved by the Ethics Committee of Zhongda Hsopital, Southeast University.
Detailed description
After PEEP titration, PEEP settings could be set by optimizing oxygenation, optimizing compliance, ARDSnet.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Optimizing oxygenation | Experimental | Other: Gas exchanges at different PEEPBest oxygenation during PEEP titration |
| Optimizing compliance | Experimental | Other: lung mechanics at different PEEPBest compliance during PEEP titration |
| ARDSnet | Experimental | Other: Hemodynamics changes at different PEEPPEEP settings according to ARDSnet table |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- COVID-19 patients with mechanical ventilation
- PO2/FIO2<300mmHg
- ages>18 years
Key exclusion criteria (3 listed)
- pneumothorax
- pregnant
- hemodynamics is unstable
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 |
|---|---|---|
| Gas exchanges at different PEEPGas exchanges measurement at different PEEP | Other | Optimizing oxygenation |
| lung mechanics at different PEEPlung mechanics measurement at different PEEP | Other | Optimizing compliance |
| Hemodynamics changes at different PEEPHemodynamics changes measurement at different PEEP | Other | ARDSnet |
Primary outcome
Respiratory system compliance improvement
Time frame: 20 minutes
the respiratory system compliance was compared among three groups
1 secondary outcome
Gas echanges improvement
Time frame: 20 minutes
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 24 Apr 2020.
- Derived from this study: PubMed 34355001Pan C, Lu C, She X, Ren H, Wei H, Xu L, Huang Y, Xia J, Yu Y, Chen L, Du B, Qiu H. Evaluation of Positive End-Expiratory Pressure Strategies in Patients With Coronavirus Disease 2019-Induced Acute Respiratory Distress Syndrome. Front Med (Lausanne). 2021 Jul 20;8:637747. doi: 10.3389/fmed.2021.637747. eCollection 2021.
- Individual participant dataSharing planned: No
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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.
Chun C Pan study director
Zhongda hospital, Southeast University, Jiangsu, 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 Gas exchanges at different PEEP, lung mechanics at different PEEP and Hemodynamics changes at different PEEP in people with COVID-19 and Mechanical Ventilation Pressure High, run by Southeast University, China 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 3 inclusion and 3 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 24 Apr 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?
Respiratory system compliance improvement (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04359251, which also lists 1 linked publication.
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 24 Apr 2020.