the PEEP Setting of ARDSNCT02361398
Individualized PEEP Setting by EIT in Patients With ARDS
A study testing the EIT guide the individualized PEEP Setting in people with the PEEP Setting of ARDS, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The investigators conducted a pilot study to compare the effect of Positive End Expiratory Pressure(PEEP) setting guide by lung electrical impedance tomography(EIT) and ARDS-net PEEP-FiO2 table on survival in subjects with mild/severe Acute Respiratory Distress Syndrome(ARDS). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- the PEEP Setting of ARDS
- What is being tested?
- the EIT guide the individualized PEEP Setting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2018to 30 Sep 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute respiratory distress syndrome with ratio of partial pressure of arterial oxygen over fraction of inspired oxygen (PaO2:FiO2)<300 and PEEP >5cmH2O
- Body mass index < =40
- Written inform consent
Who cannot join
- pregnant，intracranial hypertension
- left ventricular dysfunction (EF<25% )
- Patients with end-stage conditions(death expected within 90 days)
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Critical Care Medicine, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences,
Beijing, Beijing Municipality, 100730
About this study
Official title: Individualized Positive End Expiratory Pressure(PEEP) Setting by EIT in Patients With Acute Respiratory Distress Syndrome(ARDS)
The investigators conducted a pilot study to compare the effect of Positive End Expiratory Pressure(PEEP) setting guide by lung electrical impedance tomography(EIT) and ARDS-net PEEP-FiO2 table on survival in subjects with mild/severe Acute Respiratory Distress Syndrome(ARDS).
- Conditions
- the PEEP Setting of ARDS
- Being tested
- the EIT guide the individualized PEEP Setting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the EIT guide the individualized PEEP SettingOther
the EIT guide the individualized PEEP Setting in the EIT group
| Study group | Role | What they receive |
|---|---|---|
| EIT group | Experimental | the Individualized PEEP titration by EIT was administered to the patients in the EIT group. Receives: Other: the EIT guide the individualized PEEP Setting |
| control group | No intervention | If patients are assigned to the control group, the Individualized PEEP Setting was by PEEP-FiO2 table based on ARDS-net protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival
Non-survive and survive
Measured: 28-day
Arterial oxygenation
PaO2(mmHg) measured by blood gas analysis
Measured: 72h
Secondary outcomes (2)
length of ICU stay and mechanical ventilated day
Days of ICU stay and received mechanical ventilation(day)
Measured: 28days
pneumothorax requiring chest tube during first 7 days; barotrauma during first 7 days;
new-onset of pneumothorax and barotrauma
Measured: 7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study start10 Nov 2018
- Primary completion30 Sep 2020
- Study completion30 Sep 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 the PEEP Setting of ARDSStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yun Long, MD, Study director, Department of Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361398
- Sponsor's protocol ID
- PUMCH-ARDS-EIT
- Status last verified
- Apr 2021
- First submitted
- 13 Jan 2015
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
He H, Chi Y, Yang Y, Yuan S, Long Y, Zhao P, Frerichs I, Fu F, Moller K, Zhao Z. Early individualized positive end-expiratory pressure guided by electrical impedance tomography in acute respiratory distress syndrome: a randomized controlled clinical trial. Crit Care. 2021 Jun 30;25(1):230. doi: 10.1186/s13054-021-03645-y.
PubMed 34193224
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Positive End Expiratory Pressure(PEEP) Setting by EIT in Patients With Acute Respiratory Distress Syndrome(ARDS)
- ClinicalTrials.gov ID
- NCT02361398
- Acronym / sponsor ID
- PUMCH-ARDS-EIT
- Conditions
- the PEEP Setting of ARDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 10 Nov 2018 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 11 Feb 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.
The investigators conducted a pilot study to compare the effect of Positive End Expiratory Pressure(PEEP) setting guide by lung electrical impedance tomography(EIT) and ARDS-net PEEP-FiO2 table on survival in subjects with mild/severe Acute Respiratory Distress Syndrome(ARDS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EIT group | Experimental | Other: the EIT guide the individualized PEEP Settingthe Individualized PEEP titration by EIT was administered to the patients in the EIT group. |
| control group | No intervention | –If patients are assigned to the control group, the Individualized PEEP Setting was by PEEP-FiO2 table based on ARDS-net protocol. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- acute respiratory distress syndrome with ratio of partial pressure of arterial oxygen over fraction of inspired oxygen (PaO2:FiO2)<300 and PEEP >5cmH2O
- Body mass index < =40
- Written inform consent
Key exclusion criteria (3 listed)
- pregnant，intracranial hypertension
- left ventricular dysfunction (EF<25% )
- Patients with end-stage conditions(death expected within 90 days)
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 |
|---|---|---|
| the EIT guide the individualized PEEP Settingthe EIT guide the individualized PEEP Setting in the EIT group | Other | EIT group |
Primary outcome
survival
Time frame: 28-day
Non-survive and survive
Arterial oxygenation
Time frame: 72h
PaO2(mmHg) measured by blood gas analysis
2 secondary outcomes
length of ICU stay and mechanical ventilated day
Time frame: 28days
pneumothorax requiring chest tube during first 7 days; barotrauma during first 7 days;
Time frame: 7days
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 12 Apr 2021.
- Derived from this study: PubMed 34193224He H, Chi Y, Yang Y, Yuan S, Long Y, Zhao P, Frerichs I, Fu F, Moller K, Zhao Z. Early individualized positive end-expiratory pressure guided by electrical impedance tomography in acute respiratory distress syndrome: a randomized controlled clinical trial. Crit Care. 2021 Jun 30;25(1):230. doi: 10.1186/s13054-021-03645-y.
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.
Yun Long, MD study director
Department of Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the EIT guide the individualized PEEP Setting in people with the PEEP Setting of ARDS, run by Peking Union Medical College Hospital 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 12 Apr 2021. 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?
survival (time frame: 28-day). The study lists 2 primary outcomes in all. 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 NCT02361398, 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 12 Apr 2021.