- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07379242
Lung Recruitment Assessed by 2D/3D-EIT and R/I Ratio in Acute Respiratory Failure Patients With Mechanical Ventilation
Lung Recruitment Assessed by Two-Dimensional/Three-Dimensional Electrical Impedance Tomography and Recruitment-to-Inflation Ratio in Acute Respiratory Failure Patients With Mechanical Ventilation
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 Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Huaiwu He
- Phone Number: 010-6915-2300
- Email: tjmuhhw@126.com
Study Locations
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100730
- Recruiting
- Department of Critical Care Medicine, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences
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Contact:
- Huaiwu He
- Phone Number: 010-6915-2300
- Email: tjmuhhw@126.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lung recruitment assessed by R/I ratio and 2D/3D-EIT (PEEP titration)
Time Frame: Within 24 hours post-enrollment
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Lung recruitment potential can be predicted by the R/I ratio and the lung collapse rate calculated from 2D/3D-EIT.
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Within 24 hours post-enrollment
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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R/I ratio measured by 2D/3D-EIT
Time Frame: Within 24 hours after enrollment
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The R/I ratio can be calculated from 2D/3D-EIT.
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Within 24 hours after enrollment
|
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V/Q monitored by EIT
Time Frame: Within 24 hours after enrollment
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Ventilation and perfusion monitored by 2D/3D-EIT at different PEEP levels.
To evaluate the V/Q match, deadspace and shunt lung region.
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Within 24 hours after enrollment
|
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SpO₂ at different PEEP levels
Time Frame: Within 24 hours after enrollment
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Pulse oxygen saturation at different PEEP levels
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Within 24 hours after enrollment
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Lung compliance at different PEEP levels
Time Frame: Within 24 hours after enrollment
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Lung compliance at different PEEP levels measured via ventilator parameters
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Within 24 hours after enrollment
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Mechanical power
Time Frame: Within 24 hours after enrollment
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Mechanical power measured via ventilator parameters
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Within 24 hours after enrollment
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Collaborators and Investigators
Investigators
- Study Chair: Huaiwu He, Peking Union Medical College Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 3D EIT-based PEEP & R/I ratio
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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