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

NCT07395297 | Recruiting DMC

• 1 other identifier: S2023-270-02
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (1)

• Cough Peak Flow

  Day 1

Secondary Outcomes (10)

• Lung Ultrasound Score

  Day 1

• Sputum Viscosity

  Day 1

• Cough Dysfunction Score

  Day 1

• Heart rate

  Day 1

• diastolic pressure

  Day 1

Study Arms (1)

OLE Airway Clearance Therapy for ICU Patients with Pulmonary Infections

EXPERIMENTAL

Device: Oscillatory Lung Expansion (OLE) Therapy

Interventions

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.

OLE Airway Clearance Therapy for ICU Patients with Pulmonary Infections

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA Hospital

Beijing, Beijing Municipality, 10000, China

RECRUITING

MeSH Terms

Conditions

Pneumonia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

kaifei wang, Doctor

CONTACT

+86 10 55499330; zhaoying301301@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professer

Study Record Dates

• First Submitted: February 1, 2026
• First Posted: February 9, 2026
• Study Start: January 15, 2024
• Primary Completion: March 20, 2026
• Study Completion: April 20, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)