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Clinical Trials/NCT07379242
NCT07379242
Recruiting
Not Applicable

Lung Recruitment Assessed by Two-Dimensional/Three-Dimensional Electrical Impedance Tomography and Recruitment-to-Inflation Ratio in Acute Respiratory Failure Patients With Mechanical Ventilation

Peking Union Medical College Hospital1 site in 1 country50 target enrollmentStarted: September 1, 2025Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
50
Locations
1
Primary Endpoint
Lung recruitment assessed by R/I ratio and 2D/3D-EIT (PEEP titration)

Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Arms & Interventions

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.

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

Outcomes

Primary Outcomes

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

Time Frame: Within 24 hours post-enrollment

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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