ClinicalTrials.gg
Not yet recruitingNCT07793565EIT-PEEP-PRONEUpdated Aug 28, 2026

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

An interventional study of EIT-Guided PEEP Titration Group and ARDSNet/PEEP-FiO₂ Table in Acute Respiratory Distress Syndrome (ARDS), sponsored by XIE MIN. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-28.

Sponsored by XIE MIN · Not applicable, Interventional, and Supportive care

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Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 146 studies in Respiratory Distress Syndrome with a site in China — 54 open to participants now, 55 under way, 6 of them phase 3. Respiratory Distress Syndrome · China.

Planned enrollment
58th of 81
40 · median 100
Started
2026
with 13 others
No phase
52 of 146
21 open now
Primary completion
2027-05
later than 37 of 54 live
Registered
143rd of 146
by date

Among the 146 studies in Respiratory Distress Syndrome with a site in China, this one is the 58th largest by planned enrollment of the 81 interventional ones that give a count, is one of 14 that started in 2026, is one of 52 with no phase, reaches primary completion later than 37 of the 54 other live ones, and was the 143rd registered.

Respiratory Distress Syndrome

1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 282 are open to participants now.

Browse Respiratory Distress Syndrome studies →

Open to participants now

54 of the 146 studies in Respiratory Distress Syndrome with a site in China are open now. Recruiting first, the newest first:

49 more — sign in →

All 54 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 193 Respiratory Distress Syndrome studies recruiting now, 117 (61%) set no upper age limit and 48 (25%) stop at 75 or younger; 50 take children under 18; 9 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 146 studies in Respiratory Distress Syndrome with a site in China, or all of them as a file.
02

Study 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. 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.

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.

03

Conditions studied

  • Acute Respiratory Distress Syndrome (ARDS)
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Pregnancy or postpartum state.
  2. > 35 kg/m².
  3. Duration of invasive mechanical ventilation > 48 hours at enrollment.
  4. Severe hemodynamic instability (mean arterial pressure \< 65 mmHg on norepinephrine ≥ 0.5 μg/kg/min).
  5. Immediate need for veno-venous extracorporeal membrane oxygenation (VV-ECMO) at enrollment.
  6. 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 , asthma, interstitial lung disease); severe cardiac dysfunction ( Class III or IV, acute coronary syndrome, sustained ventricular tachyarrhythmia, or cardiogenic shock).
  7. Lack of from legally authorized representative.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    EIT-Guided PEEP Titration Group

    PEEP 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.

    Other: EIT-Guided PEEP Titration Group

  • Active comparator
    ARDSNet/PEEP-FiO₂ Table Group

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

    Other: ARDSNet/PEEP-FiO₂ Table

Interventions

  • OtherEIT-Guided PEEP Titration Group

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

  • OtherARDSNet/PEEP-FiO₂ Table

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

06

What researchers measure

Primary outcomes

  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.

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

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

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

  5. RVFAC

    Right Ventricular Fractional Area Change(%)

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

  6. TAPSE

    Tricuspid Annular Plane Systolic Excursion (mm)

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

  7. TRVmax

    Maximal Tricuspid Regurgitation Velocity (m/s)

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

  8. LVEF

    Left Ventricular Ejection Fraction(%)

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

  9. SV

    Stroke Volume(ml)

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

  10. CO

    Cardiac Output (L/min)

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

  11. 28-Day Mortality

    All-cause mortality within 28 days after enrollment.

    Time frame: 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.

    Time frame: At 28 days after enrollment

  13. ICU Length of Stay

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

    Time frame: 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.

    Time frame: During the ICU stay, assessed up to 28 days

  15. Incidence of Tracheostomy

    Proportion of patients undergoing tracheostomy during the ICU stay.

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

07

Study locations

1 site
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for May 2027, 8 months later.

Of 264 non-industry interventional studies with no phase under Respiratory Distress Syndrome, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's planned 8 months is below that.

Counting every sponsor, half of 271 studies reached it within 24 months; a quarter within 12 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 20, 2026
First posted
Aug 28, 2026
StartEst.
Aug 31, 2026
Primary completionEst.
May 20, 2027
CompletionEst.
Jun 30, 2027
Last update
Aug 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07793565
Lead sponsor
XIE MIN
Responsible party
XIE MIN (Director of the Department of Intensive Care Unit, Tongji Hospital) — Sponsor-investigator
First posted
Aug 28, 2026
Start date
Aug 31, 2026 (estimated)
Primary completion
May 20, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Aug 28, 2026

Study contacts

Min Xie, MD, PhD
Contact
Xie_m@126.com
+86-27-83665204
Jianmin Ling, MD
Contact
2018tj5179@hust.edu.cn
Min Xie
principal investigator · Tongji Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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