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The Effect of Oscillation and Lung Expansion (OLE) Therapy in Prolonged Mechanical Ventilated Patients With Atelectasis Evaluated in Multiple Methods

The Efficacy of Oscillation and Lung Expansion (OLE) Therapy Evaluated by Compterized Tomography (CT) and Electrical Impedance Tomography(EIT)in Prolonged Mechanical Ventilated Patients With Atelectasis: A Multicenter Randomized Contralled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07451405
Enrollment
60
Registered
2026-03-05
Start date
2026-03-15
Completion date
2026-10-01
Last updated
2026-03-05

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

Conditions

Atelectasis

Keywords

oscillation and lung expansion, high frequency chest wall, electrical impedance tomography, Atelectasis

Brief summary

High frequency chest wall oscillation (HFCWO) is currently one of the most common and widespread mechanical airway clearance techniques (ACTs) in clinical practice in China. As an external airway oscillation technique, it has been proven in previous clinical practices that it can help clear secretions by vibrating the chest wall, loosening the secretions adhering to the airway walls and promoting ciliary movement, thereby improving lung ventilation and re-expansion. However, there are still some groups of patients for whom this technique is not suitable in clinical practice, such as those who are uncomfortable with the oscillation, have damaged skin on the chest and back, have unstable rib fractures, or have poorly positioned tracheostomy tubes. In recent years, integrating multiple techniques into a single treatment has become a trend. Among them, oscillation and lung expansion (OLE) combines continuous positive airway pressure (CPAP), continuous high-frequency oscillation (CHFO), and nebulization, which can effectively clear airway secretions and promote lung re-expansion. Currently, only a few studies have confirmed that OLE has a positive impact on improving respiratory function in patients with acute respiratory failure, severe burns, and after lung surgery. This study aims to further compare the effects of the above two mechanical ACTs on improving lung ventilation and re-expansion by electrical impedance tomography (EIT), and optimize the clinical practice of physical therapists.

Interventions

OTHERHigh frequency chest wall oscillation or other airway clearance therapy

High frequency chest wall oscillation (HFCWO) is an external airway oscillation technique, it has been proven in previous clinical practices that it can help clear secretions by vibrating the chest wall, loosening the secretions adhering to the airway walls and promoting ciliary movement, thereby improving lung ventilation and re-expansion. We will give the patients HFCWO twice a day and each time we will give them 15HZ as frequency and 20mins as time. Other therapies are postural drainage, manual vibration...

oscillation and lung expansion (OLE) combines continuous positive airway pressure (CPAP), continuous high-frequency oscillation (CHFO), and nebulization, which can effectively clear airway secretions and promote lung re-expansion. The OLE will be given to the patients twice a day as well, and each time 10mins therapy with 2.5mins CPAP and 2.5mins CHFO cirsularly.

Sponsors

Capital Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

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

Inclusion criteria

* Age ≥18 years old * The following characteristics of high mucus secretion in the airway occur along with pulmonary infection: coughing up a large amount of white sticky phlegm, yellow phlegm or yellow purulent phlegm; Phlegm sounds can be heard in the lungs. The frequency of sputum aspiration is higher than once every 4 hours * Tracheotomy time ≥7 days * Vital signs are stable.

Exclusion criteria

* Hemodynamic instability * Inhaled oxygen concentration (FiO2) \> 60% * Untreated pneumothorax * Patients who have undergone total pneumonectomy * Hemoptysis * Pulmonary bullae, etc. * Patients with delirium and restlessness

Design outcomes

Primary

MeasureTime frameDescription
Change in Atelectatic Lung Area on Chest CTBaseline and 10 days post-treatmentAtelectatic lung area will be quantified on chest computed tomography (CT) images by a blinded radiologist using imaging analysis software. The primary outcome is the change in atelectatic lung area from baseline to 10 days post-treatment. The unit of the measures is Square centimeters (cm²)

Secondary

MeasureTime frameDescription
Ventilation distribution on Electrical impedance tomography (EIT) evaluationat admission and 3days/7days/10 days after treatmentelectrical impedance tomography will be used to evaluated the ventilation : Select a large, medium, or small electrode belt according to the patient's body size and place it on the chest (at the level of the 4th-5th intercostal spaces). Ensure that the belt position remains consistent for each measurement. Inject current through the electrode belt and measure the corresponding voltage to reconstruct the intrathoracic impedance distribution and display the corresponding images. Continuously record for 90 seconds and store the EIT data. Global inhomogeneity(GI) value describe the ventilation dstribute, the value is more closer to 0.25, is better.
Lung Ultrasound score(LUS)at admission and 10 days after treatmentLung aeration will be assessed using the Lung Ultrasound Score (LUS).Scan 12 areas to get a relevent score for degrees of lung aeration of each area according the patterns that we got on the lung ultrasound. Each lung region will be scored according to standard criteria, and the total score will be calculated. The outcome measure is the change in total LUS from baseline to 10 days post-treatment. Score ranged from 0 to 36.Higher scores indicate worse lung aeration.
Oxygenation indexat admission and 10 days after treatmentOxygenation index is measured by fingertip blood oxygen and is expressed as a percentage.
the score on Modified Borg dyspnea scaleat admission and 10 days after treatmenta number that reflect the degree of dyspnea on patient reporting according to the Modified Borg dyspnea scale
The Clinical Pulmonary Infection Scorefrom enrollment to 2 weeks after the treatmentThe Clinical Pulmonary Infection Score (CPIS) is a pulmonary infection assessment system formed by integrating multiple clinical indicators such as body temperature, white blood cell count, and oxygenation index,scaled from 0 to 12, the higher scores, the higher risk of infection.
daily costin 10 days after admissionDaily cost in HDU was calculated by a speciallist nurse and is expressd as Chinese yuan

Countries

China

Contacts

CONTACTShuo Chen
983340122@qq.com+86 13521362894

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026