ARDSNCT06594601
PEEP Titration and Lung Recruitment Potential Assessed by 3D EIT
An observational study of ARDS and Respiratory Failure, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
In a population of ARDS patients, we explore the influence of different PEEP levels on regional ventilation distribution, ventilation homogeneity, and the center of ventilation, optimal PEEP and lung recruitment potential as well as the extent of lung collapse and overdistension as detected by 3D-EIT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, Respiratory Failure
- What is being tested?
- lung recruitment potential assessed by 3D EIT and PEEP titration by 3D eit
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ARDS on mechanical ventilation.
Who may be able to join
- patients on mechanical ventilation.
- Diagnosis of ARDS was based on the Berlin definition
- lung recruitment potential assessment and PEEP titration was proper for the ARDS patients determined by the attending doctor
Who cannot join
- Under 18 years of age.
- Pregnant women;
- Ribcage malformation
- Any contraindication to the use of EIT (e.g. automatic implantable cardioverter defibrillator, and implantable pumps).
- Hemodynamic instability, unable to tolerate high PEEP;
- High-risk individuals with pneumothorax, mediastinal emphysema, etc.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Critical Care Medicine, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences,
Beijing, Beijing Municipality, 100730
Long Yun, MD, icu_longyun@126.com
Long Yun, MD
About this study
Official title: PEEP Titration and Lung Recruitment Potential Assessment by 3D EIT in ARDS Patients
In a population of ARDS patients, we explore the influence of different PEEP levels on regional ventilation distribution, ventilation homogeneity, and the center of ventilation, optimal PEEP and lung recruitment potential as well as the extent of lung collapse and overdistension as detected by 3D-EIT.
- Conditions
- ARDS, Respiratory Failure
- Being tested
- lung recruitment potential assessed by 3D EIT, PEEP titration by 3D eit
- Keywords
- ARDS, EIT, 3D-EIT
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung recruitment potential assessed by 3D EITProcedure or surgery
Patients were ventilated based on the ARDS-Net suggestions. The patients were kept at supine position. The lung recruitment potential assessed by 3D EIT was as follows:
- All patients were under pressure control mode (driving pressure 12-15 cmH2O with a tidal volume of 6-8 ml/kg predicted body weight, respiration rate12-15 bpm).
- PEEP was switched to a zero end-expiratory pressure (ZEEP) for 10 min, and FiO2 was titrated to obtain peripheral oxygen saturation (SpO2 ) \> 90%.
- PEEP was stepwise increase from 0 to 15 cmH2O PEEP in steps of 5cm H2O every 3min.And 3D EIT was used to assess lung recruitment potential.
PEEP titration by 3D eitProcedure or surgery
Patients were ventilated based on the ARDS-Net suggestions. The patients were kept at supine position. The PEEP titriatino by 3D EIT fwas as follows:
- All patients were under pressure control mode (driving pressure 12-15 cmH2O with a tidal volume of 6-8 ml/kg predicted body weight, respiration rate12-15 bpm).
- RM: PEEP was switched to a 21cmH2O for 2min, and FiO2 was titrated to obtain peripheral oxygen saturation (SpO2 ) ≥90%.
- PEEP was stepwise decrease from 21 to 0 cmH2O PEEP in steps of 3cm H2O every 2min.
- 3D EIT was used to monitor regional ventilation distribution during PEEP titration.
| Study group | Role | What they receive |
|---|---|---|
| lung recruitment potential assessed by 3D EIT in ARDS | Diagnosis of ARDS was based on the Berlin definition, who have receivied mechanical ventilation. The enrolled patients received a lung recruitment potential assessment by 3D EIT( as the follwoing mentioned ) Receives: Procedure: lung recruitment potential assessed by 3D EIT | |
| PEEP titration by 3D EIT for ARDS | Diagnosis of ARDS was based on the Berlin definition, who have receivied mechanical ventilation. The enrolled patients received a lung PEEP tirtation by 3D EIT( as the follwoing mentioned ) Receives: Procedure: PEEP titration by 3D eit |
What is being measured
The primary outcome is the main question the study is designed to answer.
OD/CL and optimal PEEP monitored by EIT
Monitoring the lung collapse and overdistension region by EIT at different PEEP levels. Measure the optimal PEEP level based on collapse and overdistension rate.
Measured: 5-10min
Secondary outcomes (4)
ventilation distribution monitored by EIT
Monitoring the lung ventilation distribution by EIT at different PEEP levels
Measured: 5-10min
GI monitored by EIT
Global Inhomogeneity (GI) Index monitored by EIT at different PEEP levels
Measured: 5-10min
CoV monitored by EIT
Center of ventilation (COV) monitored by EIT at different PEEP levels
Measured: 5-10min
V/Q monitored by EIT
Ventilation and perfusion monitored by EIT at different PEEP levels. To evaluate the V/Q match, deadspace and shunt lung region.
Measured: 5-10min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huaiwu He, PhD, Principal investigator, Department of Critical Care Medicine, Peking Union Medical College, Peking Union Medical College HospitalYun Long, PhD, Study director, Department of Critical Care Medicine, Peking Union Medical College, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594601
- Sponsor's protocol ID
- PEEP by 3D-EIT for ARDS
- Other IDs
- PUMCH
- Status last verified
- Sep 2024
- First submitted
- 2 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEEP Titration and Lung Recruitment Potential Assessment by 3D EIT in ARDS Patients
- ClinicalTrials.gov ID
- NCT06594601
- Acronym / sponsor ID
- PEEP by 3D-EIT for ARDS
- Conditions
- ARDS, Respiratory Failure
- Keywords
- ARDS, EIT, 3D-EIT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Sep 2024 (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.
In a population of ARDS patients, we explore the influence of different PEEP levels on regional ventilation distribution, ventilation homogeneity, and the center of ventilation, optimal PEEP and lung recruitment potential as well as the extent of lung collapse and overdistension as detected by 3D-EIT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lung recruitment potential assessed by 3D EIT in ARDS | – | Procedure: lung recruitment potential assessed by 3D EITDiagnosis of ARDS was based on the Berlin definition, who have receivied mechanical ventilation. The enrolled patients received a lung recruitment potential assessment by 3D EIT( as the follwoing mentioned ) |
| PEEP titration by 3D EIT for ARDS | – | Procedure: PEEP titration by 3D eitDiagnosis of ARDS was based on the Berlin definition, who have receivied mechanical ventilation. The enrolled patients received a lung PEEP tirtation by 3D EIT( as the follwoing mentioned ) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ARDS on mechanical ventilation.
Key inclusion criteria (3 listed)
- patients on mechanical ventilation.
- Diagnosis of ARDS was based on the Berlin definition
- lung recruitment potential assessment and PEEP titration was proper for the ARDS patients determined by the attending doctor
Key exclusion criteria (6 listed)
- Under 18 years of age.
- Pregnant women;
- Ribcage malformation
- Any contraindication to the use of EIT (e.g. automatic implantable cardioverter defibrillator, and implantable pumps).
- Hemodynamic instability, unable to tolerate high PEEP;
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 |
|---|---|---|
| lung recruitment potential assessed by 3D EITPatients were ventilated based on the ARDS-Net suggestions. The patients were kept at supine position. The lung recruitment potential assessed by 3D EIT was as follows: 1. All patients were under pressure control mode (driving pressure 12-15 cmH2O with a tidal volume of 6-8 ml/kg predicted body weight, respiration rate12-15 bpm). 2. PEEP was switched to a zero end-expiratory pressure (ZEEP) for 10 min, and FiO2 was titrated to obtain peripheral oxygen saturation (SpO2 ) \> 90%. 3. PEEP was stepwise increase from 0 to 15 cmH2O PEEP in steps of 5cm H2O every 3min.And 3D EIT was used to assess lung recruitment potential. | Procedure or surgery | lung recruitment potential assessed by 3D EIT in ARDS |
| PEEP titration by 3D eitPatients were ventilated based on the ARDS-Net suggestions. The patients were kept at supine position. The PEEP titriatino by 3D EIT fwas as follows: 1. All patients were under pressure control mode (driving pressure 12-15 cmH2O with a tidal volume of 6-8 ml/kg predicted body weight, respiration rate12-15 bpm). 2. RM: PEEP was switched to a 21cmH2O for 2min, and FiO2 was titrated to obtain peripheral oxygen saturation (SpO2 ) ≥90%. 3. PEEP was stepwise decrease from 21 to 0 cmH2O PEEP in steps of 3cm H2O every 2min. 4. 3D EIT was used to monitor regional ventilation distribution during PEEP titration. | Procedure or surgery | PEEP titration by 3D EIT for ARDS |
Primary outcome
OD/CL and optimal PEEP monitored by EIT
Time frame: 5-10min
Monitoring the lung collapse and overdistension region by EIT at different PEEP levels. Measure the optimal PEEP level based on collapse and overdistension rate.
4 secondary outcomes
ventilation distribution monitored by EIT
Time frame: 5-10min
GI monitored by EIT
Time frame: 5-10min
CoV monitored by EIT
Time frame: 5-10min
V/Q monitored by EIT
Time frame: 5-10min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
Huaiwu He, PhD principal investigator
Department of Critical Care Medicine, Peking Union Medical College, Peking Union Medical College Hospital
Yun Long, PhD study director
Department of Critical Care Medicine, Peking Union Medical College, Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS and Respiratory Failure, 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 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huaiwu He (15201518815, tjmuhhw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OD/CL and optimal PEEP monitored by EIT (time frame: 5-10min). 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 19 Sep 2024.