ARDS, HumanNCT05736185
Effect of Electric Impedance Tomography-Guided PEEP Titration
A study testing PEEP selection in people with ARDS, Human, run by Southeast University, China at 1 site in China.
Trial summary
Acute respiratory syndrome distress (ARDS) is a clinical common syndrome with high mortality. Mechanical ventilation (MV) is the cornerstone of management of ARDS but can lead to ventilator-induced lung injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, Human
- What is being tested?
- PEEP selection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteChina
- Study dates
- 25 Feb 2023to 30 May 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Intubated patients with moderate and severe ARDS (Berlin definition, PaO2/FiO2 ≤200 mmHg at PEEP 5 cmH2O)
- undergoing deep sedation on controlled mechanical ventilation within72 hours after ARDS onset
Who cannot join
- age <18 years old
- patient undergoing legal protection
- contra-indications to EIT (e. g. severe chest trauma or wounds)
- pneumothorax
- patient undergoing ECMO
- pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongda Hospital, School of Medicine, Southeast University
Nanjing, Jiangsu, 210009
About this study
Official title: Effect of Electric Impedance Tomography-Guided PEEP Titration on the Ventilation-perfusion Mismatch in Moderate or Severe ARDS
Acute respiratory syndrome distress (ARDS) is a clinical common syndrome with high mortality. Mechanical ventilation (MV) is the cornerstone of management of ARDS but can lead to ventilator-induced lung injury. Positive end-expiratory pressure (PEEP), as one of main component of MV, has been widely used in the clinical practice. However, how to best set PEEP is still a difficult problem for moderate to severe ARDS patients. EIT, an imaging tool evaluating the regional ventilation distribution at the bedside, can achieve the individual PEEP selection for all mechanically ventilated patients. This article compared the effect of PEEP titrated guided by EIT with fraction of inspired oxygen (FiO2)-PEEP table on the ventilation-perfusion mismatch.
- Conditions
- ARDS, Human
- Being tested
- PEEP selection
- 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.
PEEP selectionDevice
Electric impedance tomography-guided PEEP titration
| Study group | Role | What they receive |
|---|---|---|
| EIT-PEEP strategy | Experimental | PEEP selected by EIT which remained at 15 min Receives: Device: PEEP selection |
| Low FiO2-PEEP strategy | Experimental | PEEP selected by low FiO2-PEEP table which remained at 15 min Receives: Device: PEEP selection |
| High FiO2-PEEP strategy | Experimental | PEEP selected by high FiO2-PEEP table which remained at 15 min Receives: Device: PEEP selection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in ventilation-perfusion mismatch between EIT-PEEP, low-PEEP, and high PEEP
EIT-PEEP was obtained by EIT, low-PEEP was obtained by low FIO2-PEEP table, and high-PEEP was obtained by high FIO2-PEEP table.
Measured: up to 24 hours
Secondary outcomes (12)
difference in center of ventilation (COV) between EIT-PEEP, low-PEEP, and high PEEP
COV was obtained by EIT monitoring
Measured: up to 24 hours
Difference in dead space measured with EIT between EIT-PEEP, low-PEEP, and high PEEP
dead space was obtained by EIT monitoring
Measured: up to 24 hours
Difference in shunt measured with EIT between EIT-PEEP, low-PEEP, and high PEEP
shunt was obtained by EIT monitoring
Measured: up to 24 hours
Difference in wasted ventilation measured with EIT between EIT-PEEP, low-PEEP, and high PEEP
wasted ventilation was obtained by EIT monitoring
Measured: up to 24 hours
Difference in wasted perfusion measured with EIT between EIT-PEEP, low-PEEP, and high PEEP
wasted perfusion was obtained by EIT monitoring
Measured: up to 24 hours
ventilation distribution measured with EIT between EIT-PEEP, low-PEEP, and high PEEP
ventilation distribution was obtained by EIT in difference regions
Measured: up to 24 hours
perfusion distribution measured with EIT between EIT-PEEP, low-PEEP, and high PEEP
perfusion distribution was obtained by EIT in difference regions
Measured: up to 24 hours
Correlations between ventilation-perfusion mismatch and overdistension and lung collapses
Overdistension (%) and lung collapses (%) will be assessed by EIT. These two values cannot be measured separately. V/Q mismatch will be computed by EIT, and expressed in %. Correlation will be performed by linear regression.
Measured: up to 24 hours
recruitment-to-inflation (R/I) ratio
recruitment-to-inflation (R/I) ratio was computed between the two PEEP levels
Measured: up to 24 hours
PaO2/FIO2
PaO2/FIO2 was obtained by gas analysis
Measured: up to 24 hours
respiratory system mechanics
respiratory system compliance included lung compliance, chest wall compliance, and respiratory system compliance. respiratory system resistance will be computed as the inverse of compliance.
Measured: up to 24 hours
Correlation between V/Q mismatch markers and recruitability
Recruitability will be assessed between 15 and 5 cmH2O by respiratory mechanics, as the recruited volumes value (in mL). R/I ratio will be derived from these data (no unit). V/Q mismatch will be computed by EIT, and expressed in %. Correlation will be performed by linear regression.
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start25 Feb 2023
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS, HumanStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
- Investigators
- liu ling, phD, Study director, Zhongda Hospital, School of Medicine, Southeast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05736185
- Sponsor's protocol ID
- EIT-PEEPstudy
- Status last verified
- Jun 2024
- First submitted
- 9 Feb 2023
- Last updated
- 4 Jun 2024
- Results posted
- 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 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Electric Impedance Tomography-Guided PEEP Titration on the Ventilation-perfusion Mismatch in Moderate or Severe ARDS
- ClinicalTrials.gov ID
- NCT05736185
- Acronym / sponsor ID
- EIT-PEEPstudy
- Conditions
- ARDS, Human
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 25 Feb 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 21 Feb 2023 (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.
Acute respiratory syndrome distress (ARDS) is a clinical common syndrome with high mortality. Mechanical ventilation (MV) is the cornerstone of management of ARDS but can lead to ventilator-induced lung injury. Positive end-expiratory pressure (PEEP), as one of main component of MV, has been widely used in the clinical practice. However, how to best set PEEP is still a difficult problem for moderate to severe ARDS patients. EIT, an imaging tool evaluating the regional ventilation distribution at the bedside, can achieve the individual PEEP selection for all mechanically ventilated patients. This article compared the effect of PEEP titrated guided by EIT with fraction of inspired oxygen (FiO2)-PEEP table on the ventilation-perfusion mismatch.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EIT-PEEP strategy | Experimental | Device: PEEP selectionPEEP selected by EIT which remained at 15 min |
| Low FiO2-PEEP strategy | Experimental | Device: PEEP selectionPEEP selected by low FiO2-PEEP table which remained at 15 min |
| High FiO2-PEEP strategy | Experimental | Device: PEEP selectionPEEP selected by high FiO2-PEEP table which remained at 15 min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Intubated patients with moderate and severe ARDS (Berlin definition, PaO2/FiO2 ≤200 mmHg at PEEP 5 cmH2O)
- undergoing deep sedation on controlled mechanical ventilation within72 hours after ARDS onset
Key exclusion criteria (6 listed)
- age <18 years old
- patient undergoing legal protection
- contra-indications to EIT (e. g. severe chest trauma or wounds)
- pneumothorax
- patient undergoing ECMO
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 |
|---|---|---|
| PEEP selectionElectric impedance tomography-guided PEEP titration | Device | EIT-PEEP strategy, High FiO2-PEEP strategy, Low FiO2-PEEP strategy |
Primary outcome
Difference in ventilation-perfusion mismatch between EIT-PEEP, low-PEEP, and high PEEP
Time frame: up to 24 hours
EIT-PEEP was obtained by EIT, low-PEEP was obtained by low FIO2-PEEP table, and high-PEEP was obtained by high FIO2-PEEP table.
12 secondary outcomes
difference in center of ventilation (COV) between EIT-PEEP, low-PEEP, and high PEEP
Time frame: up to 24 hours
Difference in dead space measured with EIT between EIT-PEEP, low-PEEP, and high PEEP
Time frame: up to 24 hours
Difference in shunt measured with EIT between EIT-PEEP, low-PEEP, and high PEEP
Time frame: up to 24 hours
Difference in wasted ventilation measured with EIT between EIT-PEEP, low-PEEP, and high PEEP
Time frame: up to 24 hours
Difference in wasted perfusion measured with EIT between EIT-PEEP, low-PEEP, and high PEEP
Time frame: up to 24 hours
ventilation distribution measured with EIT between EIT-PEEP, low-PEEP, and high PEEP
Time frame: up to 24 hours
perfusion distribution measured with EIT between EIT-PEEP, low-PEEP, and high PEEP
Time frame: up to 24 hours
Correlations between ventilation-perfusion mismatch and overdistension and lung collapses
Time frame: up to 24 hours
recruitment-to-inflation (R/I) ratio
Time frame: up to 24 hours
PaO2/FIO2
Time frame: up to 24 hours
respiratory system mechanics
Time frame: up to 24 hours
Correlation between V/Q mismatch markers and recruitability
Time frame: up to 24 hours
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 4 Jun 2024.
- 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.
liu ling, phD study director
Zhongda Hospital, School of Medicine, Southeast University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEP selection in people with ARDS, Human, 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 2 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 4 Jun 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?
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?
Difference in ventilation-perfusion mismatch between EIT-PEEP, low-PEEP, and high PEEP (time frame: up to 24 hours). 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 4 Jun 2024.