NCT07379242

Brief Summary

The purpose of this observational study is to assess the differences and consistency in evaluating lung recruitment potential between the recruitment-to-inflation ratio (R/I ratio) and three-dimensional electrical impedance tomography (3D-EIT) and two-dimensional EIT (2D-EIT) in mechanically ventilated patients with acute respiratory failure. The main questions it aims to answer is: Are the lung recruitment potentials predicted by 3D-EIT, 2D-EIT and the R/I ratio consistent? Participants will: Undergo a standardized PEEP titration protocol with synchronized EIT monitoring; Have R/I ratios measured at high and low PEEP levels.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
5mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress63%
Sep 2025Sep 2026

Study Start

First participant enrolled

September 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

10 months

First QC Date

January 21, 2026

Last Update Submit

January 23, 2026

Conditions

Keywords

Acute respiratory failurePEEP titration3D-EIT2D-EITLung recruitabilityR/I ratio

Outcome Measures

Primary Outcomes (1)

  • Lung recruitment assessed by R/I ratio and 2D/3D-EIT (PEEP titration)

    Lung recruitment potential can be predicted by the R/I ratio and the lung collapse rate calculated from 2D/3D-EIT.

    Within 24 hours post-enrollment

Other Outcomes (5)

  • R/I ratio measured by 2D/3D-EIT

    Within 24 hours after enrollment

  • V/Q monitored by EIT

    Within 24 hours after enrollment

  • SpO₂ at different PEEP levels

    Within 24 hours after enrollment

  • +2 more other outcomes

Study Arms (1)

Mechanically ventilated patients with hypoxemia requiring clinical PEEP optimization

The study will enroll mechanically ventilated patients under sedation/analgesia without spontaneous breathing, exhibiting a oxygenation index (PaO₂/FiO₂ ratio) \<300 mmHg, and deemed clinically eligible for PEEP titration by attending physicians.

Diagnostic Test: The lung recruitment potential assessed and PEEP titration by ventilator and 2D/3D EIT

Interventions

The patient will undergo a standardized PEEP titration procedure and determination of the Recruitment-to-Inflation ratio (R/I ratio), with concurrent monitoring by both 2D- and 3D- EIT.

Mechanically ventilated patients with hypoxemia requiring clinical PEEP optimization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with acute respiratory failure who are intubated, under sedation and analgesia with controlled ventilation and no spontaneous breathing will be recruited from the Department of Critical Care Medicine, Peking Union Medical College Hospital. Additional inclusion criteria include an oxygenation index of less than 300 mmHg, clinical judgment indicating the need for PEEP titration, and no contraindications to PEEP titration or EIT examination.

You may qualify if:

  • Mechanically ventilated patients under sedation and analgesia with no spontaneous breathing.
  • Oxygenation index \< 300 mmHg.
  • Patients who are clinically judged by the attending doctor to require the PEEP titration.

You may not qualify if:

  • Aged under 18 years.
  • Pregnancy.
  • Contraindications for EIT examination (e.g. automatic implantable cardioverter defibrillator, implantable pumps, chest wounds limiting electrode belt placement, severe thoracic deformity, and others).
  • No informed consent obtained.
  • Hemodynamic instability with intolerance to high PEEP levels determined by the attending doctor.
  • High-risk populations with pneumothorax, mediastinal emphysema, and other such conditions determined by the attending doctor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Critical Care Medicine, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100730, China

RECRUITING

Study Officials

  • Huaiwu He

    Peking Union Medical College Hospital

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2026

First Posted

January 30, 2026

Study Start

September 1, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations