AtelectasisNCT07451405
The Effect of Oscillation and Lung Expansion (OLE) Therapy in Prolonged Mechanical Ventilated Patients With Atelectasis Evaluated in Multiple Methods
A study testing High frequency chest wall oscillation or other airway clearance therapy and Oscillation and lung expansion in people with Atelectasis, run by Capital Medical University at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atelectasis
- What is being tested?
- High frequency chest wall oscillation or other airway clearance therapy and Oscillation and lung expansion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 15 Mar 2026to 1 Oct 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
- 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.
Who cannot join
- Hemodynamic instability
- Inhaled oxygen concentration (FiO2) > 60%
- Untreated pneumothorax
- Patients who have undergone total pneumonectomy
- Hemoptysis
- Pulmonary bullae, etc.
- Patients with delirium and restlessness
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 1 recruiting
- Recruiting
Respiratory rehabilitation center
Beijing, Beijing Municipality, 100144
Shuo Chen, 010-56981092
- Completed
Shuo Chen
Beijing
About this study
Official title: 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
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.
- Conditions
- Atelectasis
- Being tested
- High frequency chest wall oscillation or other airway clearance therapy, Oscillation and lung expansion
- Keywords
- oscillation and lung expansion, high frequency chest wall, electrical impedance tomography, Atelectasis
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High frequency chest wall oscillation or other airway clearance therapyOther
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 expansionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Coventional therapy group | Placebo comparator | This group conducted casual treatment and airway clearance (except oscillation an lung expansion therapy) Receives: Other: High frequency chest wall oscillation or other airway clearance therapy |
| OLE group | Experimental | This group conducted casual treatment and oscillation an lung expansion on daily therapy Receives: Other: High frequency chest wall oscillation or other airway clearance therapy; Other: Oscillation and lung expansion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Atelectatic Lung Area on Chest CT
Atelectatic 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)
Measured: Baseline and 10 days post-treatment
Secondary outcomes (6)
Ventilation distribution on Electrical impedance tomography (EIT) evaluation
electrical 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.
Measured: at admission and 3days/7days/10 days after treatment
Lung Ultrasound score(LUS)
Lung 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.
Measured: at admission and 10 days after treatment
Oxygenation index
Oxygenation index is measured by fingertip blood oxygen and is expressed as a percentage.
Measured: at admission and 10 days after treatment
the score on Modified Borg dyspnea scale
a number that reflect the degree of dyspnea on patient reporting according to the Modified Borg dyspnea scale
Measured: at admission and 10 days after treatment
The Clinical Pulmonary Infection Score
The 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.
Measured: from enrollment to 2 weeks after the treatment
daily cost
Daily cost in HDU was calculated by a speciallist nurse and is expressd as Chinese yuan
Measured: in 10 days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start15 Mar 2026 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtelectasisStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuo Chen, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451405
- Sponsor's protocol ID
- 20251211001
- Status last verified
- Dec 2025
- First submitted
- 30 Dec 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07451405
- Acronym / sponsor ID
- 20251211001
- Conditions
- Atelectasis
- Keywords
- oscillation and lung expansion, high frequency chest wall, electrical impedance tomography, Atelectasis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 5 Mar 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coventional therapy group | Placebo comparator | Other: High frequency chest wall oscillation or other airway clearance therapyThis group conducted casual treatment and airway clearance (except oscillation an lung expansion therapy) |
| OLE group | Experimental | Other: High frequency chest wall oscillation or other airway clearance therapy, Other: Oscillation and lung expansionThis group conducted casual treatment and oscillation an lung expansion on daily therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- Hemodynamic instability
- Inhaled oxygen concentration (FiO2) > 60%
- Untreated pneumothorax
- Patients who have undergone total pneumonectomy
- Hemoptysis
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 |
|---|---|---|
| High frequency chest wall oscillation or other airway clearance therapyHigh 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... | Other | Coventional therapy group, OLE group |
| Oscillation and lung expansionoscillation 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. | Other | OLE group |
Primary outcome
Change in Atelectatic Lung Area on Chest CT
Time frame: Baseline and 10 days post-treatment
Atelectatic 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)
6 secondary outcomes
Ventilation distribution on Electrical impedance tomography (EIT) evaluation
Time frame: at admission and 3days/7days/10 days after treatment
Lung Ultrasound score(LUS)
Time frame: at admission and 10 days after treatment
Oxygenation index
Time frame: at admission and 10 days after treatment
the score on Modified Borg dyspnea scale
Time frame: at admission and 10 days after treatment
The Clinical Pulmonary Infection Score
Time frame: from enrollment to 2 weeks after the treatment
daily cost
Time frame: in 10 days after admission
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 5 Mar 2026.
- Individual participant dataSharing planned: Yes
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High frequency chest wall oscillation or other airway clearance therapy and Oscillation and lung expansion in people with Atelectasis, run by Capital Medical University at 2 sites 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 4 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 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 Shuo Chen (+86 13521362894, 983340122@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Atelectatic Lung Area on Chest CT (time frame: Baseline and 10 days post-treatment). 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 5 Mar 2026.