Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 3:31 AM
Study NCT ID:
NCT07451405
Status:
RECRUITING
Last Update Posted:
2026-03-05
First Post:
2025-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Oscillation and Lung Expansion (OLE) Therapy in Prolonged Mechanical Ventilated Patients With Atelectasis Evaluated in Multiple Methods
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001261', 'term': 'Pulmonary Atelectasis'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035641', 'term': 'Chest Wall Oscillation'}], 'ancestors': [{'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-28', 'studyFirstSubmitDate': '2025-12-30', 'studyFirstSubmitQcDate': '2026-02-28', 'lastUpdatePostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Atelectatic Lung Area on Chest CT', 'timeFrame': 'Baseline and 10 days post-treatment', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'Ventilation distribution on Electrical impedance tomography (EIT) evaluation', 'timeFrame': 'at admission and 3days/7days/10 days after treatment', 'description': "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."}, {'measure': 'Lung Ultrasound score(LUS)', 'timeFrame': 'at admission and 10 days after treatment', 'description': '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.'}, {'measure': 'Oxygenation index', 'timeFrame': 'at admission and 10 days after treatment', 'description': 'Oxygenation index is measured by fingertip blood oxygen and is expressed as a percentage.'}, {'measure': 'the score on Modified Borg dyspnea scale', 'timeFrame': 'at admission and 10 days after treatment', 'description': 'a number that reflect the degree of dyspnea on patient reporting according to the Modified Borg dyspnea scale'}, {'measure': 'The Clinical Pulmonary Infection Score', 'timeFrame': 'from enrollment to 2 weeks after the treatment', 'description': '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.'}, {'measure': 'daily cost', 'timeFrame': 'in 10 days after admission', 'description': 'Daily cost in HDU was calculated by a speciallist nurse and is expressd as Chinese yuan'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oscillation and lung expansion', 'high frequency chest wall', 'electrical impedance tomography', 'Atelectasis'], 'conditions': ['Atelectasis']}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years old\n* 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\n* Tracheotomy time ≥7 days\n* Vital signs are stable.\n\nExclusion Criteria:\n\n* Hemodynamic instability\n* Inhaled oxygen concentration (FiO2) \\> 60%\n* Untreated pneumothorax\n* Patients who have undergone total pneumonectomy\n* Hemoptysis\n* Pulmonary bullae, etc.\n* Patients with delirium and restlessness'}, 'identificationModule': {'nctId': 'NCT07451405', 'briefTitle': 'The Effect of Oscillation and Lung Expansion (OLE) Therapy in Prolonged Mechanical Ventilated Patients With Atelectasis Evaluated in Multiple Methods', 'organization': {'class': 'OTHER', 'fullName': 'Capital Medical University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '20251211001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Coventional therapy group', 'description': 'This group conducted casual treatment and airway clearance (except oscillation an lung expansion therapy)', 'interventionNames': ['Other: High frequency chest wall oscillation or other airway clearance therapy']}, {'type': 'EXPERIMENTAL', 'label': 'OLE group', 'description': 'This group conducted casual treatment and oscillation an lung expansion on daily therapy', 'interventionNames': ['Other: High frequency chest wall oscillation or other airway clearance therapy', 'Other: Oscillation and lung expansion']}], 'interventions': [{'name': 'High frequency chest wall oscillation or other airway clearance therapy', 'type': 'OTHER', 'description': '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...', 'armGroupLabels': ['Coventional therapy group', 'OLE group']}, {'name': 'Oscillation and lung expansion', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['OLE group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100144', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shuo Chen', 'role': 'CONTACT', 'phone': '010-56981092'}], 'facility': 'Respiratory rehabilitation center', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'status': 'COMPLETED', 'country': 'China', 'facility': 'Shuo Chen', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Shuo Chen', 'role': 'CONTACT', 'email': '983340122@qq.com', 'phone': '+86 13521362894'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Capital Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physical therapy', 'investigatorFullName': 'Shuo Chen', 'investigatorAffiliation': 'Capital Medical University'}}}}