ARDSNCT04734340
The Study of EIT-guided Ventilation Strategy on ARDS Patients
A study testing EIT-guided PEEP setting and ARDS-net PEEP setting in people with ARDS and Pulmonary Perfusion, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This study is a clinical randomized controlled study.The objective of this study is to compare the prognosis of patients with ARDS between eit-v / q-oriented individualized ventilation strategy and traditional lung protection ventilation strategy, and to establish the demonstration application of eit-v / q-oriented… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ARDS, Pulmonary Perfusion
- What is being tested?
- EIT-guided PEEP setting and ARDS-net PEEP setting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 1 Jun 2023
- 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
- According to ARDS Berlin standard, ARDS, PaO2 / FiO2 < 200mmhg, peep > 5cmh2o;
- According to clinical judgment, lung recruitment therapy is needed due to hypoxemia;
- The subjects or their families signed informed consent.
- Admission to ICU was less than 72 hours;
- The estimated duration of mechanical ventilation was more than or equal to 48 hours;
- Age ≥ 18 years old and ≤ 80 years old;
Who cannot join
- The patients with heart implants could not be monitored by EIT;
- Patients or their families refused to participate in the study;
- Hypernatremia
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Yun Long, 13911608699, ly_icu@aliyun.com
Siyi Yuan, 15201518815, yuansiyizqh@163.com
About this study
This study is a clinical randomized controlled study.The objective of this study is to compare the prognosis of patients with ARDS between eit-v / q-oriented individualized ventilation strategy and traditional lung protection ventilation strategy, and to establish the demonstration application of eit-v / q-oriented ventilation strategy in ARDS
- Conditions
- ARDS, Pulmonary Perfusion
- Being tested
- EIT-guided PEEP setting, ARDS-net PEEP setting
- Keywords
- EIT, ARDS, pulmonary perfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EIT-guided PEEP settingProcedure or surgery
Ventilator parameter setting by EIT
ARDS-net PEEP settingProcedure or surgery
Ventilator parameter setting according to ARDS-net table
| Study group | Role | What they receive |
|---|---|---|
| EIT-guided group | Experimental | Treatment based on EIT Receives: Procedure: EIT-guided PEEP setting |
| Control group | Placebo comparator | Treatment based on ARDS-net Peep setting Receives: Procedure: ARDS-net PEEP setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
ventilation free days
Measured: 1 Day
Secondary outcomes (1)
28-day mortality
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start1 Jan 2021
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734340
- Sponsor's protocol ID
- EIT-RCT
- Status last verified
- Jan 2021
- First submitted
- 28 Jan 2021
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of EIT-guided Ventilation Strategy on ARDS Patients
- ClinicalTrials.gov ID
- NCT04734340
- Acronym / sponsor ID
- EIT-RCT
- Conditions
- ARDS, Pulmonary Perfusion
- Keywords
- EIT, ARDS, pulmonary perfusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 2 Feb 2021 (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 study is a clinical randomized controlled study.The objective of this study is to compare the prognosis of patients with ARDS between eit-v / q-oriented individualized ventilation strategy and traditional lung protection ventilation strategy, and to establish the demonstration application of eit-v / q-oriented ventilation strategy in ARDS
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EIT-guided group | Experimental | Procedure: EIT-guided PEEP settingTreatment based on EIT |
| Control group | Placebo comparator | Procedure: ARDS-net PEEP settingTreatment based on ARDS-net Peep setting |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- According to ARDS Berlin standard, ARDS, PaO2 / FiO2 < 200mmhg, peep > 5cmh2o;
- According to clinical judgment, lung recruitment therapy is needed due to hypoxemia;
- The subjects or their families signed informed consent.
- Admission to ICU was less than 72 hours;
- The estimated duration of mechanical ventilation was more than or equal to 48 hours;
Key exclusion criteria (3 listed)
- The patients with heart implants could not be monitored by EIT;
- Patients or their families refused to participate in the study;
- Hypernatremia
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 |
|---|---|---|
| EIT-guided PEEP settingVentilator parameter setting by EIT | Procedure or surgery | EIT-guided group |
| ARDS-net PEEP settingVentilator parameter setting according to ARDS-net table | Procedure or surgery | Control group |
Primary outcome
ventilation free days
Time frame: 1 Day
1 secondary outcome
28-day mortality
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EIT-guided PEEP setting and ARDS-net PEEP setting in people with ARDS and Pulmonary Perfusion, 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 6 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: status not confirmed, as of the sponsor's last update on 2 Feb 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yun Long (13911608699, ly_icu@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ventilation free days (time frame: 1 Day). 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 2 Feb 2021.