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NCT Number: NCT07395297

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chinese PLA Hospital

Beijing, Beijing Municipality, 10000, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Oscillatory Lung Expansion (OLE) Therapy

Device

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.

Primary outcomes

  1. Cough Peak Flow

    Time frame: Day 1

Secondary outcomes

  1. Lung Ultrasound Score

    Time frame: Day 1

  2. Sputum Viscosity

    Time frame: Day 1

  3. Cough Dysfunction Score

    Time frame: Day 1

  4. Heart rate

    Time frame: Day 1

  5. diastolic pressure

    Time frame: Day 1

  6. systolic pressure

    Time frame: Day 1

  7. Tidal Impedance Variation Before Cough (TIV)

    Time frame: Day 1

  8. End-Expiratory Lung Impedance (EELI)

    Time frame: Day 1

  9. Center of Ventilation (COV)

    Time frame: Day 1

  10. Ventilation Heterogeneity Index (GI)

    Time frame: Day 1

Study contacts

Contact information is provided by the study sponsor or research team.

kaifei wang, Doctor

CONTACT

[email protected]

+86 10 55499330

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 9, 2026
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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