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Acute Respiratory Distress Syndrome (ARDS)EIT-PEEP-PRONENCT07793565

Early EIT-Guided PEEP Titration on Pulmonary Physiology in Patients With Moderate-to-Severe ARDS Undergoing Prone Positioning (EIT-PEEP-PRONE)

A study testing EIT-Guided PEEP Titration Group and ARDSNet/PEEP-FiO₂ Table in people with Acute Respiratory Distress Syndrome (ARDS), run by XIE MIN at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Background: Electrical impedance tomography (EIT)-guided PEEP titration has been shown to improve regional ventilation distribution, increase respiratory system compliance, and reduce mechanical power in patients with acute respiratory distress syndrome (ARDS), but its effect on mortality remains unproven. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
EIT-Guided PEEP Titration Group and ARDSNet/PEEP-FiO₂ Table
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
31 Aug 2026to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Diagnosis of moderate-to-severe ARDS according to the Berlin definition, with a PaO₂/FiO₂ ratio < 150 mmHg on optimal mechanical ventilation.
  • Clinical decision has been made to place a central venous catheter (internal jugular or subclavian vein) for clinical management.

Who cannot join

  • Pregnancy or postpartum state.
  • BMI > 35 kg/m².
  • Duration of invasive mechanical ventilation > 48 hours at enrollment.
  • Severe hemodynamic instability (mean arterial pressure < 65 mmHg on norepinephrine ≥ 0.5 μg/kg/min).
  • Immediate need for veno-venous extracorporeal membrane oxygenation (VV-ECMO) at enrollment.
  • Contraindications to prone positioning or EIT monitoring, including but not limited to: facial or cervical trauma; unstable spinal, femoral, pelvic, or rib fractures; recent cardiac surgery; pneumothorax; elevated intracranial pressure; pacemaker or implantable cardioverter-defibrillator; severe chronic lung disease (e.g., severe COPD, asthma, interstitial lung disease); severe cardiac dysfunction (New York Heart Association Class III or IV, acute coronary syndrome, sustained ventricular tachyarrhythmia, or cardiogenic shock).
  • Lack of informed consent from legally authorized representative.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Min Xie, MD, PhD contact

+86-27-83665204

Xie_m@126.com

Jianmin Ling, MD contact

2018tj5179@hust.edu.cn

China1 site
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

    Min Xie, MD, PhD, +86-27-83665204, 2018tj5179@hust.edu.cn

Other trials in China

About this study

Official title: A Randomized Controlled Trial of Early EIT-Guided PEEP Titration on Pulmonary Physiology in Moderate-to-Severe ARDS Patients Undergoing Prone Positioning

Background: Electrical impedance tomography (EIT)-guided PEEP titration has been shown to improve regional ventilation distribution, increase respiratory system compliance, and reduce mechanical power in patients with acute respiratory distress syndrome (ARDS), but its effect on mortality remains unproven. In patients with moderate-to-severe ARDS, prone positioning for 4 hours allows pulmonary ventilation and perfusion to reach a new steady state, with optimization of ventilation-perfusion (V/Q) matching and other pulmonary physiological parameters. However, whether dynamic PEEP titration guided by EIT at this time point can further optimize V/Q matching and other pulmonary physiological parameters compared with conventional methods has not been reported.

Objective: To investigate whether EIT-guided PEEP titration performed at 4 hours after prone positioning initiation can further optimize V/Q matching and other pulmonary physiological parameters in patients with moderate-to-severe ARDS undergoing prone positioning.

Read more

Methods: This is a prospective, single-center, randomized, open-label, parallel-controlled physiological study. A total of 40 patients with moderate-to-severe ARDS (Berlin definition, PaO₂/FiO₂ < 150 mmHg) will be enrolled and randomized in a 1:1 ratio to either the EIT-guided group or the control group. PEEP intervention will be performed at 4 hours after prone positioning initiation (T1) in both groups: the EIT group receives EIT-guided PEEP titration, while the control group receives PEEP set according to the ARDSNet/PEEP-FiO₂ table. The primary outcome is V/Q matching percentage assessed by EIT at 18 hours of prone positioning (T2) and 6 hours after supine repositioning (T3). Secondary outcomes include respiratory mechanics, EIT-derived parameters (regional ventilation distribution, global inhomogeneity index, center of ventilation), oxygenation indices, echocardiographic measures of cardiac function, and clinical outcomes (28-day mortality, ventilator-free days, ICU length of stay, etc.).

Conclusion: This study will provide physiological evidence for early EIT-guided PEEP titration in patients with moderate-to-severe ARDS undergoing prone positioning, and will lay the foundation for future large-scale clinical trials.

Being tested
EIT-Guided PEEP Titration Group, ARDSNet/PEEP-FiO₂ Table
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.

  • EIT-Guided PEEP Titration GroupOther

    PEEP titration is performed during mechanical ventilation to optimize respiratory mechanics and ventilation-perfusion matching in patients with ARDS.

  • ARDSNet/PEEP-FiO₂ TableOther

    PEEP will be set according to the ARDSNet/PEEP-FiO₂ table at 4 hours after prone positioning initiation (T1).

Study groups in NCT07793565
Study groupRoleWhat they receive
EIT-Guided PEEP Titration GroupExperimentalPEEP will be titrated using EIT monitoring at 4 hours after prone positioning initiation (T1). The optimal PEEP will be determined at the intersection of the cumulative collapse and overdistension curves, or at the lowest global inhomogeneity index if the intersection occurs between two PEEP levels.
Receives: Other: EIT-Guided PEEP Titration Group
ARDSNet/PEEP-FiO₂ Table GroupActive comparatorPEEP will be set according to the ARDSNet/PEEP-FiO₂ table at 4 hours after prone positioning initiation (T1).
Receives: Other: ARDSNet/PEEP-FiO₂ Table

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ventilation-Perfusion (V/Q) Matching Percentage

    V/Q matching percentage assessed by electrical impedance tomography (EIT) using the EIT Evaluation Tool (SDMI) V2.7.1. V/Q matching reflects the efficiency of pulmonary gas exchange and is calculated from regional ventilation and perfusion distribution maps.

    Measured: At 18 hours of prone positioning (T2) and at 6 hours after supine repositioning (T3)

Secondary outcomes (15)
  1. Respiratory System Compliance

    Respiratory system compliance (Crs) calculated as tidal volume divided by driving pressure (plateau pressure minus PEEP), measured under volume-controlled ventilation.

    Measured: Baseline, T2 (18h prone), and T3 (6h post-supine)

  2. Driving Pressure

    Driving pressure (DP) calculated as plateau pressure (Pplat) minus PEEP, measured under volume-controlled ventilation.

    Measured: At baseline (T0), at 18 hours of prone positioning (T2), and at 6 hours after supine repositioning (T3)

  3. EIT-Derived Regional Ventilation Distribution

    Regional ventilation distribution assessed by EIT, expressed as percentage of tidal impedance variation in four regions of interest (ROIs): ventral (ROI 1), mid-ventral (ROI 2), mid-dorsal (ROI 3), and dorsal (ROI 4), each corresponding to 25% of the anteroposterior diameter, Center of Ventilation (CoV), Global Inhomogeneity Index (GI), Shunt, Dead Space.

    Measured: At baseline (T0), at 18 hours of prone positioning (T2), and at 6 hours after supine repositioning (T3)

  4. RVEDA/LVEDA

    Right Ventricular End-Diastolic Area to Left Ventricular End-Diastolic Area Ratio

    Measured: At baseline (T0) and at 6 hours after supine repositioning (T3)

  5. RVFAC

    Right Ventricular Fractional Area Change(%)

    Measured: Baseline and 6h post-supine repositioning (T3)

  6. TAPSE

    Tricuspid Annular Plane Systolic Excursion (mm)

    Measured: Baseline and 6h post-supine repositioning (T3)

  7. TRVmax

    Maximal Tricuspid Regurgitation Velocity (m/s)

    Measured: Baseline and 6h post-supine repositioning (T3)

  8. LVEF

    Left Ventricular Ejection Fraction(%)

    Measured: At baseline (T0) and at 6 hours after supine repositioning (T3)

  9. SV

    Stroke Volume(ml)

    Measured: Baseline and 6h post-supine repositioning (T3)

  10. CO

    Cardiac Output (L/min)

    Measured: Baseline and 6h post-supine repositioning (T3)

  11. 28-Day Mortality

    All-cause mortality within 28 days after enrollment.

    Measured: At 28 days after enrollment

  12. Ventilator-Free Days at 28 Days

    Number of days alive and free from invasive mechanical ventilation during the first 28 days after enrollment.

    Measured: At 28 days after enrollment

  13. ICU Length of Stay

    Total duration of ICU stay (in days) from enrollment to ICU discharge or death.

    Measured: From enrollment through ICU discharge, assessed up to 28 days

  14. Incidence of ECMO Use

    Proportion of patients requiring veno-venous extracorporeal membrane oxygenation (VV-ECMO) during the ICU stay.

    Measured: During the ICU stay, assessed up to 28 days

  15. Incidence of Tracheostomy

    Proportion of patients undergoing tracheostomy during the ICU stay.

    Measured: During the ICU stay, assessed up to 28 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2026
  2. Study start31 Aug 2026 (estimated)
  3. Primary completion20 May 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07793565
Sponsor's protocol ID
TJ-IRB202605019
Acronym
EIT-PEEP-PRONE
Status last verified
Aug 2026
First submitted
20 Aug 2026
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sang L, Lin Z, Zhao Z. How often do we need to update PEEP setting during prone positioning in ARDS? Crit Care. 2024 Feb 26;28(1):60. doi: 10.1186/s13054-024-04847-w. No abstract available.

    PubMed 38409024
  • Servetti A, Battaglini D, Patroniti NA, Al Sharie S, Jouryyeh B, Al-Husinat L, Marini JJ, Rocco PRM. Optimising positive end-expiratory pressure in acute respiratory distress syndrome: a narrative review of approaches to titration. Br J Anaesth. 2026 May;136(5):1472-1481. doi: 10.1016/j.bja.2025.12.048. Epub 2026 Jan 27.

    PubMed 41592990
  • Cornejo R, Papazian L, Martin Delgado MC. Physiological effects of prone positioning during invasive mechanical ventilation: beyond PaO2. Intensive Care Med. 2026 Mar;52(3):574-577. doi: 10.1007/s00134-026-08305-9. Epub 2026 Feb 9. No abstract available.

    PubMed 41661291
  • Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.

    PubMed 23688302
  • Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.

    PubMed 26903337
  • Al-Husinat L, Azzam S, Al Sharie S, Araydah M, Battaglini D, Abushehab S, Cortes-Puentes GA, Schultz MJ, Rocco PRM. A narrative review on the future of ARDS: evolving definitions, pathophysiology, and tailored management. Crit Care. 2025 Feb 24;29(1):88. doi: 10.1186/s13054-025-05291-0.

    PubMed 39994815
  • Wang R, Wang W, Tang X, Qi Z, Li T, Liu Y, Li H, Yan J, Yang H, Lyu W, Li Z, Sun B, Gan G. Association between ventilation-perfusion matching improvement during initial prone positioning and ICU mortality in patients with moderate to severe ARDS: a prospective two-center study. Ann Intensive Care. 2025 May 21;15(1):69. doi: 10.1186/s13613-025-01489-1.

    PubMed 40394400
  • Songsangvorn N, Xu Y, Lu C, Rotstein O, Brochard L, Slutsky AS, Burns KEA, Zhang H. Electrical impedance tomography-guided positive end-expiratory pressure titration in ARDS: a systematic review and meta-analysis. Intensive Care Med. 2024 May;50(5):617-631. doi: 10.1007/s00134-024-07362-2. Epub 2024 Mar 21.

    PubMed 38512400
  • He H, Zhao Z, Becher T, Bellani G, Yoshida T, Amato MBP, Long Y, Frerichs I; REspiratory and Critical Care medicine EIT study (RECCE) group. Recommendations for lung ventilation and perfusion assessment with chest electrical impedance tomography in critically ill adult patients: an international evidence-based and expert Delphi consensus study. EClinicalMedicine. 2025 Oct 17;89:103575. doi: 10.1016/j.eclinm.2025.103575. eCollection 2025 Nov.

    PubMed 41158153

Questions about this trial

What is this clinical trial studying?

A study testing EIT-Guided PEEP Titration Group and ARDSNet/PEEP-FiO₂ Table in people with Acute Respiratory Distress Syndrome (ARDS), run by XIE MIN 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 7 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: opening soon, as of the sponsor's last update on 28 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Min Xie, MD, PhD (+86-27-83665204, Xie_m@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ventilation-Perfusion (V/Q) Matching Percentage (time frame: At 18 hours of prone positioning (T2) and at 6 hours after supine repositioning (T3)). 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 NCT07793565, which also lists 9 linked publications.

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 28 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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