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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07395297
Enrollment
62
Registered
2026-02-09
Start date
2024-01-15
Completion date
2026-04-20
Last updated
2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia

Brief 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. 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.

Interventions

DEVICEOscillatory 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.

Sponsors

Chinese PLA General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Cough Peak FlowDay 1

Secondary

MeasureTime frame
Lung Ultrasound ScoreDay 1
Sputum ViscosityDay 1
Cough Dysfunction ScoreDay 1
Heart rateDay 1
diastolic pressureDay 1
systolic pressureDay 1
Tidal Impedance Variation Before Cough (TIV)Day 1
End-Expiratory Lung Impedance (EELI)Day 1
Center of Ventilation (COV)Day 1
Ventilation Heterogeneity Index (GI)Day 1

Countries

China

Contacts

CONTACTkaifei wang, Doctor
zhaoying301301@163.com+86 10 55499330

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026