Effectiveness of OLE Airway Clearance Therapy in ICU Patients With Pulmonary Infections

February 6, 2026 updated by: wang kaifei, Chinese PLA General Hospital

The Effectiveness Study of OLE Airway Clearance Therapy in ICU Patients With Pulmonary Infections in EIT Evaluation.

This study aims to explore the application of Electrical Impedance Tomography (EIT) in evaluating the effectiveness of OLE (Oscillatory Lung Expansion) airway clearance therapy for ICU patients with pulmonary infections. The goal is to understand the treatment response differences in patients with various causes of atelectasis (lung collapse). The study will include adult patients diagnosed with pulmonary infections and admitted to the ICU. The primary endpoint of the study is the peak cough flow (CPF), which measures the patient's ability to clear secretions from the lungs through coughing.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 10000
        • Recruiting
        • Chinese PLA Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Clearly diagnosed with pulmonary infection in the ICU, confirmed by microbiological tests (sputum culture, blood culture, etc.) or imaging tests (chest CT, chest X-ray);
  2. Age ≥ 18 years;
  3. Respiratory support is oxygen therapy (nasal cannula or face mask oxygen therapy);
  4. Sputum volume > 30 ml/day;
  5. The patient or their legal representative signs the informed consent form.

Exclusion Criteria:

  1. Pregnant or breastfeeding women;
  2. Presence of respiratory or circulatory failure (requiring mechanical ventilation or vasopressor support to maintain circulation);
  3. Untreated tension pneumothorax;
  4. Body Mass Index (BMI) exceeding 50 kg/m²;
  5. Rib deformities or severe thoracic deformities;
  6. Contraindications for the use of EIT (such as implanted automatic cardiac defibrillators, acute chest trauma, subcutaneous implanted pumps, etc.);
  7. Early withdrawal from the study or incomplete clinical data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OLE Airway Clearance Therapy for ICU Patients with Pulmonary Infections
Device: Oscillatory Lung Expansion (OLE) Therapy
The OLE treatment device is used with synchronized nebulization of 10 ml of 0.9% NaCl solution. The continuous positive airway pressure during the exhalation phase is set to 10-20 cmH₂O, with continuous high-frequency oscillation at a rate of 170-230 times per minute. Each treatment session lasts for 10 minutes. The oxygen therapy parameters are set by the clinician and remain unchanged throughout the experiment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cough Peak Flow
Time Frame: Day 1
Day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Heart rate
Time Frame: Day 1
Day 1
Lung Ultrasound Score
Time Frame: Day 1
Day 1
Sputum Viscosity
Time Frame: Day 1
Day 1
Cough Dysfunction Score
Time Frame: Day 1
Day 1
diastolic pressure
Time Frame: Day 1
Day 1
systolic pressure
Time Frame: Day 1
Day 1
Tidal Impedance Variation Before Cough (TIV)
Time Frame: Day 1
Day 1
End-Expiratory Lung Impedance (EELI)
Time Frame: Day 1
Day 1
Center of Ventilation (COV)
Time Frame: Day 1
Day 1
Ventilation Heterogeneity Index (GI)
Time Frame: Day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2024

Primary Completion (Estimated)

March 20, 2026

Study Completion (Estimated)

April 20, 2026

Study Registration Dates

First Submitted

February 1, 2026

First Submitted That Met QC Criteria

February 6, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2023-270-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Subscribe