Pneumonia
Conditions
Keywords
Pneumonia, Intrapulmonary percussion ventilation, mechanical ventilation, electrical impedance tomography, pulmonary infection
Brief summary
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
Interventions
DEVICEIntrapulmonary percussion ventilation
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.
OTHERusual care
Participants in the control group will receive standard airway clearance therapy only, including postural drainage, humidification, high-frequency chest wall oscillation, and suctioning or fiberoptic bronchoscopy when necessary. The MetaNeb system will not be used.
Sponsors
Zhongnan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years; 2. Meeting the diagnostic criteria for pulmonary infection, defined as follows: meeting the diagnostic criteria for hospital-acquired pneumonia (HAP) or ventilator-associated pneumonia (VAP) according to the Chinese Guidelines for the Diagnosis and Treatment of Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia in Adults (2018 edition), or meeting the diagnostic criteria for community-acquired pneumonia (CAP) according to the Chinese Guidelines for the Diagnosis and Treatment of Community-Acquired Pneumonia in Adults (2016 edition); 3. Oxygenation index (PaO₂/FiO₂) ≤ 300; 4. Currently receiving invasive mechanical ventilation, with no planned liberation from invasive mechanical ventilation within the next 24 hours; 5. Receiving analgesia and sedation; 6. Written informed consent provided by the patient's family member or legally authorized representative.
Exclusion criteria
1. Presence of severe hemodynamic instability (norepinephrine dose \> 0.5 μg/kg/min); 2. Markedly elevated intracranial pressure (\> 25 mmHg) or a condition requiring strict intracranial pressure control; 3. Severe pulmonary bullae, untreated tension pneumothorax or undrained mediastinal emphysema; 4. Unstable chest wall, flail chest, recent thoracic or airway surgery, or severe thoracic spine injury; 5. Active massive hemoptysis; 6. Severe bronchospasm or inability to tolerate fluctuations in airway pressure; 7. Inability to place the EIT chest belt, such as open thoracic surgical wounds or skin lesions at the belt placement site; 8. Receiving extracorporeal membrane oxygenation (ECMO); 9. Acute exacerbation of chronic obstructive pulmonary disease as the primary reason for the current episode of invasive mechanical ventilation; 10. Expected death within 24 hours, or a decision already made to withhold or withdraw life-sustaining treatment; 11. Pregnancy or breastfeeding; 12. Concurrent participation in another clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to successful liberation from invasive mechanical ventilation within 28 days after randomization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
| Weaning success rate | From randomization to successful weaning, assessed up to 28 days | 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. |
| ICU length of stay | Follow-up assessments were conducted 1 month after hospital discharge (30 ± 7 days), using the date | 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. |
| Hospital length of stay | Follow-up assessments were conducted 1 month after hospital discharge (30 ± 7 days), using the date | Hospital length of stay was defined as the number of days from hospital admission to discharge or death, calculated as calendar days. |
| 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. | Before the first treatment (T0), after 5 consecutive days of treatment (T3) | Score according to the following aspects: 1. body temperature (12 hour average, ℃): 0 point: 36.1-38.4 ℃; 1 point: 38.5-38.9 ℃. 2. 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. 3. 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. 4. oxygenation index (mmHg): 0 point: \>240; 2 points: ≤240 without ARDS. 5. chest X-ray infiltrating shadow: 0 point: no infiltrating shadow; 1 point: patchy infiltrating shadow; 2 points: fusion of patchy infiltrating shadow. 6. 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. |
| Ichikado Score | Before the first treatment (T0), after 5 consecutive days of treatment (T3) | 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. |
| Incidence of MetaNeb-Related Adverse Events | From the first intervention session (T0) until 24 hours after the last MetaNeb treatment, up to 5 days. | 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. |
| 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) | — |
Countries
China
Contacts
CONTACTQingting Xie
Outcome results
None listed