PneumoniaNCT07395297
Effectiveness of OLE Airway Clearance Therapy in ICU Patients With Pulmonary Infections
A study testing Oscillatory Lung Expansion (OLE) Therapy in people with Pneumonia, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- Oscillatory Lung Expansion (OLE) Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2024to 20 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
- Age ≥ 18 years;
- Respiratory support is oxygen therapy (nasal cannula or face mask oxygen therapy);
- Sputum volume > 30 ml/day;
- The patient or their legal representative signs the informed consent form.
Who cannot join
- Pregnant or breastfeeding women;
- Presence of respiratory or circulatory failure (requiring mechanical ventilation or vasopressor support to maintain circulation);
- Untreated tension pneumothorax;
- Body Mass Index (BMI) exceeding 50 kg/m²;
- Rib deformities or severe thoracic deformities;
- Contraindications for the use of EIT (such as implanted automatic cardiac defibrillators, acute chest trauma, subcutaneous implanted pumps, etc.);
- Early withdrawal from the study or incomplete clinical data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese PLA Hospital
Beijing, Beijing Municipality, 10000
About this study
Official title: 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.
- Conditions
- Pneumonia
- Being tested
- Oscillatory Lung Expansion (OLE) Therapy
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oscillatory Lung Expansion (OLE) TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| OLE Airway Clearance Therapy for ICU Patients with Pulmonary Infections | Experimental | Not described Receives: Device: Oscillatory Lung Expansion (OLE) Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cough Peak Flow
Measured: Day 1
Secondary outcomes (10)
Lung Ultrasound Score
Measured: Day 1
Sputum Viscosity
Measured: Day 1
Cough Dysfunction Score
Measured: Day 1
Heart rate
Measured: Day 1
diastolic pressure
Measured: Day 1
systolic pressure
Measured: Day 1
Tidal Impedance Variation Before Cough (TIV)
Measured: Day 1
End-Expiratory Lung Impedance (EELI)
Measured: Day 1
Center of Ventilation (COV)
Measured: Day 1
Ventilation Heterogeneity Index (GI)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start15 Jan 2024
- Primary completion20 Mar 2026 (estimated)
- Study completion20 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wang kaifei, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395297
- Sponsor's protocol ID
- S2023-270-02
- Status last verified
- Jan 2026
- First submitted
- 1 Feb 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness Study of OLE Airway Clearance Therapy in ICU Patients With Pulmonary Infections in EIT Evaluation.
- ClinicalTrials.gov ID
- NCT07395297
- Acronym / sponsor ID
- S2023-270-02
- Conditions
- Pneumonia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 20 Mar 2026 (estimated)
- Study completion
- 20 Apr 2026 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OLE Airway Clearance Therapy for ICU Patients with Pulmonary Infections | Experimental | Device: Oscillatory Lung Expansion (OLE) Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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);
- Age ≥ 18 years;
- Respiratory support is oxygen therapy (nasal cannula or face mask oxygen therapy);
- Sputum volume > 30 ml/day;
- The patient or their legal representative signs the informed consent form.
Key exclusion criteria (7 listed)
- Pregnant or breastfeeding women;
- Presence of respiratory or circulatory failure (requiring mechanical ventilation or vasopressor support to maintain circulation);
- Untreated tension pneumothorax;
- Body Mass Index (BMI) exceeding 50 kg/m²;
- Rib deformities or severe thoracic deformities;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oscillatory Lung Expansion (OLE) TherapyThe 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. | Device | OLE Airway Clearance Therapy for ICU Patients with Pulmonary Infections |
Primary outcome
Cough Peak Flow
Time frame: Day 1
10 secondary outcomes
Lung Ultrasound Score
Time frame: Day 1
Sputum Viscosity
Time frame: Day 1
Cough Dysfunction Score
Time frame: Day 1
Heart rate
Time frame: Day 1
diastolic pressure
Time frame: Day 1
systolic pressure
Time frame: Day 1
Tidal Impedance Variation Before Cough (TIV)
Time frame: Day 1
End-Expiratory Lung Impedance (EELI)
Time frame: Day 1
Center of Ventilation (COV)
Time frame: Day 1
Ventilation Heterogeneity Index (GI)
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oscillatory Lung Expansion (OLE) Therapy in people with Pneumonia, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact kaifei wang, Doctor (+86 10 55499330, zhaoying301301@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cough Peak Flow (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.