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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).
The main questions it aims to answer are:
Does 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?
Participants will:
Receive 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intrapulmonary percussion ventilation | Experimental |
| |
| usual care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrapulmonary percussion ventilation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to successful liberation from invasive mechanical ventilation within 28 days after randomization | Time to successful liberation from invasive mechanical ventilation within 28 days after randomization, defined as discontinuation of invasive mechanical ventilation followed by at least 48 consecutive hours alive and free from invasive mechanical ventilation. Death before successful liberation will be treated as a competing event. | 28 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| arterial oxygen partial pressure | Before the first treatment (T0) and after 5-day treatment (T3) | |
| cough peak expiratory flow | Before the first treatment (T0) and after 5-day treatment (T3) | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingting Xie | Contact | +86 13296652698 | qingtingxxx@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongnan Hospital of Wuhan University | Recruiting | Wuhan | Hubei | 430071 | China |
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| usual care | Device | 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. |
|
| Weaning success rate |
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. |
| From randomization to successful weaning, assessed up to 28 days |
| ICU length of stay | 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. | Follow-up assessments were conducted 1 month after hospital discharge (30 ± 7 days), using the date |
| Hospital length of stay | Hospital length of stay was defined as the number of days from hospital admission to discharge or death, calculated as calendar days. | Follow-up assessments were conducted 1 month after hospital discharge (30 ± 7 days), using the date |
| 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. | Score according to the following aspects:
| Before the first treatment (T0), after 5 consecutive days of treatment (T3) |
| Ichikado Score | 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. | Before the first treatment (T0), after 5 consecutive days of treatment (T3) |
| Incidence of MetaNeb-Related Adverse Events | The proportion of participants experiencing any predefined MetaNeb-related adverse events during the intervention period. Adverse 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. Adverse events will be assessed during each treatment session and recorded according to predefined criteria. | From the first intervention session (T0) until 24 hours after the last MetaNeb treatment, up to 5 days. |
| tidal impedance variation (TIV) | Before the first treatment (T0), immediately after the first treatment (T1), 30min after the first treatment (T2), and after 5-day treatment (T3) |
| center of ventilation (CoV) | Before the first treatment (T0), immediately after the first treatment (T1), 30min after the first treatment (T2), and after 5-day treatment (T3) |
| global inhomogeneity index (GI Index) | Before the first treatment (T0), immediately after the first treatment (T1), 30min after the first treatment (T2), and after 5-day treatment (T3) |
| driving airway pressure | Before the first treatment (T0), immediately after the first treatment (T1), 30min after the first treatment (T2), and after 5-day treatment (T3) |
| compliance of the respiratory system | Before the first treatment (T0), immediately after the first treatment (T1), 30min after the first treatment (T2), and after 5-day treatment (T3) |
| airway resistance | Before the first treatment (T0), immediately after the first treatment (T1), 30min after the first treatment (T2), and after 5-day treatment (T3) |
| arterial carbon dioxide partial pressure | Before the first treatment (T0) and after 5-day treatment (T3) |
| arterial oxygen saturation | Before the first treatment (T0) and after 5-day treatment (T3) |
| blood lactic acid | Before the first treatment (T0) and after 5-day treatment (T3) |
| PaO₂/FiO₂ | Before the first treatment (T0) and after 5-day treatment (T3) |
| heart rate | Before the first treatment (T0), immediately after the first treatment (T1), 30min after the first treatment (T2), and after 5-day treatment (T3) |
| percutaneous arterial oxygen saturation | Before the first treatment (T0), immediately after the first treatment (T1), 30min after the first treatment (T2), and after 5-day treatment (T3) |
| respiratory rate | Before the first treatment (T0), immediately after the first treatment (T1), 30min after the first treatment (T2), and after 5-day treatment (T3) |
| blood pressure | Before the first treatment (T0), immediately after the first treatment (T1), 30min after the first treatment (T2), and after 5-day treatment (T3) |
| end-expiratory lung impedance (EELI) | Before the first treatment (T0), immediately after the first treatment (T1), 30min after the first treatment (T2), and after 5-day treatment (T3) |
| peak airway pressure | Before the first treatment (T0), immediately after the first treatment (T1), 30min after the first treatment (T2), and after 5-day treatment (T3) |
| plateau airway pressure | Before the first treatment (T0), immediately after the first treatment (T1), 30min after the first treatment (T2), and after 5-day treatment (T3) |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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