NCT07453966 Efficacy and Safety of Intrapulmonary Percussive Ventilation in Patients With Pulmonary Infection Receiving Invasive Mechanical Ventilation

Eligibility & Interventions

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This trial targets 96 participants in total. It began in 2026-03-06 with a primary completion date of 2027-03-01.

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

Eligibility Criteria

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 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; radiographic evidence of new or progressive pulmonary infiltrates plus at least two clinical criteria, including fever or hypothermia, leukocytosis or leukopenia, purulent respiratory secretions, or worsening oxygenation. 3. Oxygenation index (PaO₂/FiO₂) ≤ 300; 4. Currently receiving invasive mechanical ventilation and expected to require mechanical ventilation for ≥ 5 days; 5. 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 or untreated tension pneumothorax or undrained mediastinal emphysema; 4. Active massive hemoptysis; 5. Severe bronchospasm with inability to tolerate fluctuations in airway pressure; 6. Unstable chest wall, flail chest, recent thoracic surgery, or severe thoracic spine injury; 7. Receiving extracorporeal membrane oxygenation (ECMO); 8. Pregnant or breastfeeding women; 9. Inability to place the EIT chest belt (e.g., open thoracic surgical wounds or skin lesions at the belt placement site); 10. Concurrent participation in another clinical trial.

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