Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:50 AM
Study NCT ID:
NCT07453966
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Intrapulmonary Percussive Ventilation in Patients With Pulmonary Infection Receiving Invasive Mechanical Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-04', 'studyFirstSubmitDate': '2026-02-13', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of mechanical ventilation', 'timeFrame': '48 hours after weaning'}], 'secondaryOutcomes': [{'measure': 'arterial oxygen partial pressure', 'timeFrame': 'Before the first treatment (T0) and after 5-day treatment (T3)'}, {'measure': 'cough peak expiratory flow', 'timeFrame': 'Before the first treatment (T0) and after 5-day treatment (T3)'}, {'measure': 'Weaning success rate', 'timeFrame': 'From randomization to successful weaning, assessed up to 28 days', 'description': 'Successful weaning was defined as the absence of the need for reintubation or invasive mechanical ventilation within 48 hours after planned extubation. The successful weaning rate was calculated as the number of patients with successful weaning divided by the total number of patients who underwent a weaning attempt.'}, {'measure': 'ICU length of stay', 'timeFrame': 'Follow-up assessments were conducted 1 month after hospital discharge (30 ± 7 days), using the date', 'description': 'ICU length of stay was defined as the number of days from the date of first ICU admission to the date of final ICU discharge or death, calculated as calendar days.'}, {'measure': 'Hospital length of stay', 'timeFrame': 'Follow-up assessments were conducted 1 month after hospital discharge (30 ± 7 days), using the date', 'description': 'Hospital length of stay was defined as the number of days from hospital admission to discharge or death, calculated as calendar days.'}, {'measure': 'Clinical Pulmonary Infection Score (CPIS) composite. The total score is obtained by summing the scores of various indicators. The higher the score, the more severe the degree of lung infection.', 'timeFrame': 'Before the first treatment (T0), after 5 consecutive days of treatment (T3)', 'description': 'Score according to the following aspects:\n\n1. body temperature (12 hour average, ℃): 0 point: 36.1-38.4 ℃; 1 point: 38.5-38.9 ℃.\n2. white blood cell count (× 10 ⁹ /l): 0 point: 4.0-11.0; 1 point: 11.1-17.0; 2 points: ≤ 3.9 or ≥ 17.1.\n3. secretion (24-hour aspirate characteristics and quantity): 0 point: no sputum or a little; 1 point: moderate to massive, non purulent; 2 points: moderate to massive, purulent.\n4. oxygenation index (mmHg): 0 point: \\>240; 2 points: ≤240 without ARDS.\n5. chest X-ray infiltrating shadow: 0 point: no infiltrating shadow; 1 point: patchy infiltrating shadow; 2 points: fusion of patchy infiltrating shadow.\n6. sputum or airway aspirate culture: 0 point: no pathogenic bacteria cultured; 1 point: ≥ 1 pathogen; 2 points: the same bacteria are cultured for ≥ 2 times, or the smear is consistent with the cultured pathogen.'}, {'measure': 'Ichikado Score', 'timeFrame': 'Before the first treatment (T0), after 5 consecutive days of treatment (T3)', 'description': 'The lungs are divided into six zones: the upper zone above the level of the carina, the middle zone between the carina and the inferior pulmonary veins, and the lower zone below the level of the inferior pulmonary veins. Within each zone, the predominant CT pattern is identified and assigned a weighted score based on the severity of lung damage, where a score of 1 indicates normal lung tissue, 2 indicates ground-glass opacity, 3 indicates consolidation, 4 indicates ground-glass opacity with traction bronchiectasis or bronchiolectasis, 5 indicates consolidation with traction bronchiectasis or bronchiolectasis, and 6 indicates crazy-paving appearance. For each of the six zones, we estimates the percentage of the zone affected by the predominant pattern in increments of 10%, Zone Score = (Weight Score of the Pattern) × (Percentage of Zone Involved), Total Ichikado Score = (Sum of Six Zone Scores) / 6. A higher score indicating more extensive and severe lung involvement.'}, {'measure': 'Incidence of MetaNeb-Related Adverse Events', 'timeFrame': 'From the first intervention session (T0) until 24 hours after the last MetaNeb treatment, up to 5 days.', 'description': 'The proportion of participants experiencing any predefined MetaNeb-related adverse events during the intervention period.\n\nAdverse events include, but are not limited to: Oxygen desaturation (SpO₂ decrease ≥5% from baseline or SpO₂ \\<90%); Hemodynamic instability (heart rate change ≥20% from baseline or systolic blood pressure change ≥20% from baseline); New-onset arrhythmia; Barotrauma (including pneumothorax confirmed by imaging); Treatment intolerance leading to premature discontinuation.\n\nAdverse events will be assessed during each treatment session and recorded according to predefined criteria.'}, {'measure': 'tidal impedance variation (TIV)', 'timeFrame': 'Before the first treatment (T0), immediately after the first treatment (T1), 30min after the first treatment (T2), and after 5-day treatment (T3)'}, {'measure': 'ventilation/perfusion (V/Q)', 'timeFrame': 'Before the first treatment (T0), immediately after the first treatment (T1), 30min after the first treatment (T2), and after 5-day treatment (T3)'}, {'measure': 'center of ventilation (CoV)', 'timeFrame': 'Before the first treatment (T0), immediately after the first treatment (T1), 30min after the first treatment (T2), and after 5-day treatment (T3)'}, {'measure': 'global inhomogeneity index (GI Index)', 'timeFrame': 'Before the first treatment (T0), immediately after the first treatment (T1), 30min after the first treatment (T2), and after 5-day treatment (T3)'}, {'measure': 'driving airway pressure', 'timeFrame': 'Before the first treatment (T0), immediately after the first treatment (T1), 30min after the first treatment (T2), and after 5-day treatment (T3)'}, {'measure': 'compliance of the respiratory system', 'timeFrame': 'Before the first treatment (T0), immediately after the first treatment (T1), 30min after the first treatment (T2), and after 5-day treatment (T3)'}, {'measure': 'airway resistance', 'timeFrame': 'Before the first treatment (T0), immediately after the first treatment (T1), 30min after the first treatment (T2), and after 5-day treatment (T3)'}, {'measure': 'arterial carbon dioxide partial pressure', 'timeFrame': 'Before the first treatment (T0) and after 5-day treatment (T3)'}, {'measure': 'arterial oxygen saturation', 'timeFrame': 'Before the first treatment (T0) and after 5-day treatment (T3)'}, {'measure': 'blood lactic acid', 'timeFrame': 'Before the first treatment (T0) and after 5-day treatment (T3)'}, {'measure': 'PaO₂/FiO₂', 'timeFrame': 'Before the first treatment (T0) and after 5-day treatment (T3)'}, {'measure': 'heart rate', 'timeFrame': 'Before the first treatment (T0), immediately after the first treatment (T1), 30min after the first treatment (T2), and after 5-day treatment (T3)'}, {'measure': 'percutaneous arterial oxygen saturation', 'timeFrame': 'Before the first treatment (T0), immediately after the first treatment (T1), 30min after the first treatment (T2), and after 5-day treatment (T3)'}, {'measure': 'respiratory rate', 'timeFrame': 'Before the first treatment (T0), immediately after the first treatment (T1), 30min after the first treatment (T2), and after 5-day treatment (T3)'}, {'measure': 'blood pressure', 'timeFrame': 'Before the first treatment (T0), immediately after the first treatment (T1), 30min after the first treatment (T2), and after 5-day treatment (T3)'}, {'measure': 'end-expiratory lung impedance (EELI)', 'timeFrame': 'Before the first treatment (T0), immediately after the first treatment (T1), 30min after the first treatment (T2), and after 5-day treatment (T3)'}, {'measure': 'peak airway pressure', 'timeFrame': 'Before the first treatment (T0), immediately after the first treatment (T1), 30min after the first treatment (T2), and after 5-day treatment (T3)'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Pneumonia', 'Intrapulmonary percussion ventilation', 'mechanical ventilation', 'electrical impedance tomography', 'pulmonary infection'], 'conditions': ['Pneumonia']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn whether adding intrapulmonary percussion ventilation (IPV) to standard airway clearance treatment improves clinical outcomes in invasively mechanically ventilated patients with pulmonary infection. It will also evaluate the safety of IPV in this population and assess changes in lung ventilation using electrical impedance tomography (EIT).\n\nThe main questions it aims to answer are:\n\nDoes adding IPV shorten the duration of invasive mechanical ventilation compared with standard therapy alone? Does IPV improve regional and global lung ventilation? Does IPV improve clinical indicators, including oxygenation, lung mechanics, and pulmonary infection scores? Is IPV safe in mechanically ventilated patients with pulmonary infection?\n\nParticipants will:\n\nReceive either standard therapy alone or standard therapy plus IPV Undergo serial EIT monitoring at predefined time points Receive routine clinical assessments and ventilator parameter monitoring during ICU stay Be followed until successful weaning, discharge, or completion of hospitalization'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. age ≥ 18 years\n2. Meeting the diagnostic criteria for pulmonary infection: meeting the diagnostic criteria for hospital-acquired pneumonia and ventilator-associated pneumonia as defined in the Chinese Guidelines for the Diagnosis and Treatment of Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia in Adults, or meeting the diagnostic criteria for community-acquired pneumonia as defined in the Chinese Guidelines for the Diagnosis and Treatment of Community-Acquired Pneumonia in Adults\n3. Oxygenation index (PaO₂/FiO₂) ≤ 300\n4. Currently receiving invasive mechanical ventilation and expected to require mechanical ventilation for ≥ 48 hours\n5. Written informed consent provided by the patient's family member or legally authorized representative\n\nExclusion Criteria:\n\n1. Presence of severe hemodynamic instability (norepinephrine dose \\> 0.5 μg/kg/min)\n2. Markedly elevated intracranial pressure (\\> 25 mmHg) or a condition requiring strict intracranial pressure control\n3. Untreated tension pneumothorax or undrained mediastinal emphysema\n4. Unstable chest wall, flail chest, recent thoracic surgery, or severe thoracic spine injury\n5. Pregnant or breastfeeding women\n6. Inability to place the EIT chest belt (e.g., open thoracic surgical wounds or skin lesions at the belt placement site)\n7. Concurrent participation in another clinical trial"}, 'identificationModule': {'nctId': 'NCT07453966', 'briefTitle': 'Efficacy and Safety of Intrapulmonary Percussive Ventilation in Patients With Pulmonary Infection Receiving Invasive Mechanical Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Zhongnan Hospital'}, 'officialTitle': 'Efficacy and Safety of Intrapulmonary Percussive Ventilation in Patients With Pulmonary Infection Receiving Invasive Mechanical Ventilation Assessed by Electrical Impedance Tomography: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2025400'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intrapulmonary percussion ventilation', 'interventionNames': ['Device: Intrapulmonary percussion ventilation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'usual care', 'interventionNames': ['Device: usual care']}], 'interventions': [{'name': 'Intrapulmonary percussion ventilation', 'type': 'DEVICE', 'otherNames': ['continuous high-frequency oscillation'], 'description': 'In addition to standard airway clearance therapy, intrapulmonary percussive ventilation (IPV) will be administered using the MetaNeb system for 15 minutes per session, twice daily (with an interval of at least 2 hours between sessions), for 5 consecutive days or until extubation or hospital discharge, whichever occurs first.', 'armGroupLabels': ['Intrapulmonary percussion ventilation']}, {'name': 'usual care', 'type': 'DEVICE', 'description': 'Participants in the control group will receive standard airway clearance therapy only, including postural drainage, humidification, and suctioning or fiberoptic bronchoscopy when necessary. In addition, they will undergo high-frequency chest wall oscillation therapy for 15 minutes per session, twice daily (with an interval of at least 2 hours between sessions). The MetaNeb system will not be used.', 'armGroupLabels': ['usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430071', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'contacts': [{'name': 'Qingting Xie', 'role': 'CONTACT', 'email': 'qingtingxxx@163.com', 'phone': '+86 13296652698'}], 'facility': 'Zhongnan Hospital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Qingting Xie', 'role': 'CONTACT', 'email': 'qingtingxxx@163.com', 'phone': '+86 13296652698'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhongnan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician', 'investigatorFullName': 'ZhiYong Peng', 'investigatorAffiliation': 'Zhongnan Hospital'}}}}