ARDSARDS，PEEPNCT06808438
Incremental and Decremental PEEP Titration by Diverse Strategies in Subjects With ARDS: A Prospective Physiological Study
An observational study of ARDS, run by West China Hospital at 1 site in China.
Trial summary
The investigators conducted a prospective physiological observation study on ARDS population, described their physiological and EIT indexes with various PEEP titration methods, and also compared and analyzed those indexes to determine whether there were differences among various PEEP titration methods.The objective of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS
- What is being tested?
- Esophageal pressure catheter
- Type of treatment
- Medical device
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2024to 28 Jul 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
- Adult, Older adult
Study population: ntubated and mechanical ventilated patients over 18 years with moderate-severe ARDS (PaO2 /FIO2 ,200 mm Hg) admitted to the ICU within 48 hours were enrolled from October 2022 to July 2024.
Who may be able to join
- Intubated and mechanical ventilated patients in ICU within 48 hours
- Be over 18 years old
- With moderate-severe ARDS (PaO2 /FIO2 ,200 mm Hg)
Who cannot join
- Severe chronic obstructive pulmonary diseases
- Pulmonary bulla(>1CM) or pneumothorax or pneumomediastinum or subcutaneous emphysema
- Pregnancy
- BMI≥35kg/m2
- Suspected pulmonary vascular hemorrhage
- Disturbance of consciousness or intracranial hypertension
Show all 12Show fewer
- Severe cardiac dysfunction (New York Heart Association Class III or IV, acute -Coronary syndrome or persistent ventricular tachyarrhythmia), cardiogenic shock or after major cardiac surgery
- Hemodynamic instability (i.e., mean arterial pressure [MAP]<60 mm Hg despite vasopressor use
- The medical team considering short periods of high pressure to be unsafe
- Contraindications for placement of esophageal pressure catheters (e.g., esophageal varix or fracture of skull base)
- Contraindications for EIT monitoring (including pacemaker, or cutaneous diseases which limiting electrode placement)
- Agonal stage or end-stages of diseases
Trial locations and contacts
1 site in 1 country.
China1 site
West China Hospital of Sichuan University, Chengdu
Chengdu, Sichuan, 610041
About this study
Official title: Research on Precision Individualized Mechanical Ventilation Strategies for ARDS Guided by Electrical Impedance Tomography Monitoring and Evaluation of the Differences in Ventilation and Perfusion Distribution
The investigators conducted a prospective physiological observation study on ARDS population, described their physiological and EIT indexes with various PEEP titration methods, and also compared and analyzed those indexes to determine whether there were differences among various PEEP titration methods.The objective of this study was to explore and uncover the physiological differences in response to optimal PEEP in different ways，and analyzed the correlation of the optimal PEEP in these different ways.
- Conditions
- ARDS
- Being tested
- Esophageal pressure catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal pressure catheterDevice
Esophageal pressure was monitored with an esophageal pressure catheter
What is being measured
The primary outcome is the main question the study is designed to answer.
the selected PEEP values
- Method-specific selected PEEP values
- Description: The principal endpoint was the set of 15 method-specific selected PEEP values determined for each patient.
- Unit of Measure: cmH₂O
Measured: through study completion, an average of 1 year
Secondary outcomes (11)
SpO2/FiO2 at each selected PEEP
SpO2/FiO2 measured at each selected PEEP. This study will separately measure peripheral oxygen saturation (SpO₂, unit: %) and fraction of inspired oxygen (FiO₂, unit: %). Because both measurements share the same unit (%), they will not be reported as separate outcome measures. Instead, they will be aggregated into a single reported value: the SpO₂/FiO₂ ratio (dimensionless). At each selected positive end-expiratory pressure (PEEP) level, the ratio will be calculated as S/F = SpO₂ (%) ÷ FiO₂ (%), and this ratio will be recorded as the final outcome measure.
Measured: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
respiratory system compliance value at each selected PEEP
This study will directly record the respiratory system compliance value as measured and displayed by the ventilator (unit: mL/cmH₂O) at each selected PEEP.
Measured: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
plateau pressure at each selected PEEP
At each selected positive end-expiratory pressure (PEEP) level, plateau pressure will be directly recorded from the ventilator after performing an inspiratory hold maneuver. This value is displayed by the ventilator in cmH₂O
Measured: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
Driving Pressure at each selected PEEP
At each selected positive end-expiratory pressure (PEEP) level, plateau pressure (Pplat, unit: cmH₂O) will be measured via the ventilator, and the corresponding PEEP value (unit: cmH₂O) will be recorded. Driving pressure (ΔP) is calculated as the difference between the two: ΔP = Pplat - PEEP (unit: cmH₂O).
Measured: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
End-inspiratory Transpulmonary Pressure (PTPi) at each selected PEEP
After placement of an esophageal pressure catheter, the ventilator will monitor esophageal pressure (Pes) and airway pressure. At each selected positive end-expiratory pressure (PEEP) level, an end-inspiratory hold maneuver will be performed. The end-inspiratory transpulmonary pressure (PTPi) is calculated as the difference between the airway plateau pressure (Pplat) measured during the hold and the corresponding esophageal pressure (Pes): PTPi = Pplat - Pes (unit: cmH₂O).
Measured: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
End-expiratory Transpulmonary Pressure (PTPe) at each selected PEEP
After placement of an esophageal pressure catheter, the ventilator will monitor esophageal pressure (Pes) and airway pressure. At each selected positive end-expiratory pressure (PEEP) level, an end-expiratory hold maneuver will be performed. The end-inspiratory transpulmonary pressure (PTPe) is calculated as the difference between the PEEP measured during the hold and the corresponding esophageal pressure (Pes): PTPe = PEEP - Pes (unit: cmH₂O). This calculated value is the single reported outcome measure
Measured: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
transpulmonary driving pressure at each selected PEEP
After placement of an esophageal pressure catheter, the ventilator will monitor transpulmonary pressures. At each selected PEEP level, end-inspiratory transpulmonary pressure (PTPi) and end-expiratory transpulmonary pressure (PTPe) are obtained during inspiratory and expiratory hold maneuvers, respectively. Both are measured in cmH₂O. Transpulmonary driving pressure is calculated as the difference: ΔPtp = PTPi - PTPe (unit: cmH₂O).
Measured: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
EIT-derived Regional Ventilation Parameters at each selected PEEP level
Using electrical impedance tomography (EIT), the lung is divided into four regions of interest (ROI I to ROI IV) from ventral to dorsal. For each ROI, the percentage of tidal impedance variation relative to total tidal impedance variation is recorded (% of total). unit: cmH₂O
Measured: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
the center of ventilation (COV) at each selected PEEP level
the center of ventilation (COV) is calculated as the position of the ventilation center along the ventral-dorsal axis, expressed as a percentage (0% = ventral, 100% = dorsal). this parameter is measured in %
Measured: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
CL HP% (overdistension region) at each selected PEEP level
Using electrical impedance tomography (EIT)，based on regional compliance analysis，CL HP% represent the percentage of lung regions showing a decrease in compliance at high PEEP due to overdistension (unit: %).
Measured: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
CL LP% (collapse region) at selected PEEP
Using electrical impedance tomography (EIT)，based on regional compliance analysis，CL LP% represent the percentage of lung regions showing a decrease in compliance at low PEEP due to collapse (unit: %).
Measured: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start10 Dec 2024
- Primary completion28 Jul 2025
- Study completion28 Jul 2025
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 West China 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Yongfang, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808438
- Sponsor's protocol ID
- PEEP Titration
- Other IDs
- 2024YFFK0329, 2024ZD0530000
- Acronym
- ARDS，PEEP
- Status last verified
- Aug 2026
- First submitted
- 5 Dec 2024
- Last updated
- 26 Aug 2026
- 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 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Precision Individualized Mechanical Ventilation Strategies for ARDS Guided by Electrical Impedance Tomography Monitoring and Evaluation of the Differences in Ventilation and Perfusion Distribution
- ClinicalTrials.gov ID
- NCT06808438
- Acronym / sponsor ID
- ARDS，PEEP / PEEP Titration
- Conditions
- ARDS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 28 Jul 2025 (actual)
- Study completion
- 28 Jul 2025 (actual)
- First posted
- 5 Feb 2025 (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.
The investigators conducted a prospective physiological observation study on ARDS population, described their physiological and EIT indexes with various PEEP titration methods, and also compared and analyzed those indexes to determine whether there were differences among various PEEP titration methods.The objective of this study was to explore and uncover the physiological differences in response to optimal PEEP in different ways，and analyzed the correlation of the optimal PEEP in these different ways.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- ntubated and mechanical ventilated patients over 18 years with moderate-severe ARDS (PaO2 /FIO2 ,200 mm Hg) admitted to the ICU within 48 hours were enrolled from October 2022 to July 2024.
Key inclusion criteria (3 listed)
- Intubated and mechanical ventilated patients in ICU within 48 hours
- Be over 18 years old
- With moderate-severe ARDS (PaO2 /FIO2 ,200 mm Hg)
Key exclusion criteria (12 listed)
- Severe chronic obstructive pulmonary diseases
- Pulmonary bulla(>1CM) or pneumothorax or pneumomediastinum or subcutaneous emphysema
- Pregnancy
- BMI≥35kg/m2
- Suspected pulmonary vascular hemorrhage
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 |
|---|---|---|
| Esophageal pressure catheterEsophageal pressure was monitored with an esophageal pressure catheter | Device | – |
Primary outcome
the selected PEEP values
Time frame: through study completion, an average of 1 year
1. Method-specific selected PEEP values * Description: The principal endpoint was the set of 15 method-specific selected PEEP values determined for each patient. * Unit of Measure: cmH₂O
11 secondary outcomes
SpO2/FiO2 at each selected PEEP
Time frame: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
respiratory system compliance value at each selected PEEP
Time frame: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
plateau pressure at each selected PEEP
Time frame: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
Driving Pressure at each selected PEEP
Time frame: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
End-inspiratory Transpulmonary Pressure (PTPi) at each selected PEEP
Time frame: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
End-expiratory Transpulmonary Pressure (PTPe) at each selected PEEP
Time frame: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
transpulmonary driving pressure at each selected PEEP
Time frame: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
EIT-derived Regional Ventilation Parameters at each selected PEEP level
Time frame: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
the center of ventilation (COV) at each selected PEEP level
Time frame: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
CL HP% (overdistension region) at each selected PEEP level
Time frame: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
CL LP% (collapse region) at selected PEEP
Time frame: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
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 26 Aug 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by West China 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 12 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 26 Aug 2026. 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?
the selected PEEP values (time frame: through study completion, an average of 1 year). 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 26 Aug 2026.