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RecruitingNCT06594601Updated Sep 19, 2024

PEEP Titration and Lung Recruitment Potential Assessed by 3D EIT

An observational study in ARDS and Respiratory Failure, sponsored by Peking Union Medical College Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Peking Union Medical College Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Jan 2024; still recruiting 2 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • ARDS
  • Respiratory Failure

Keywords

  • ARDS
  • EIT
  • 3D-EIT
03

In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 297 are open to participants now.

This study's planned enrollment of 50 is below the median of 100 across 546 observational studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with ARDS on mechanical ventilation.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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 )

    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 )

    Procedure: PEEP titration by 3D eit

Interventions

  • Procedurelung recruitment potential assessed by 3D EIT

    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: 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.

  • ProcedurePEEP titration by 3D eit

    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: 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 5-10min

Secondary outcomes

  1. ventilation distribution monitored by EIT

    Monitoring the lung ventilation distribution by EIT at different PEEP levels

    Time frame: 5-10min

  2. GI monitored by EIT

    Global Inhomogeneity (GI) Index monitored by EIT at different PEEP levels

    Time frame: 5-10min

  3. CoV monitored by EIT

    Center of ventilation (COV) monitored by EIT at different PEEP levels

    Time frame: 5-10min

  4. 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.

    Time frame: 5-10min

07

Study locations

1 of 1 sites recruiting
  • Department of Critical Care Medicine, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences,
    Beijing, Beijing 100730, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06594601
Lead sponsor
Peking Union Medical College Hospital
Responsible party
Sponsor
First posted
Sep 19, 2024
Start date
Jan 1, 2024
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Sep 19, 2024

Study contacts

Huaiwu He
Contact
tjmuhhw@163.com
15201518815
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

Oversight

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

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