RecruitingNot ApplicableNCT07453966

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

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


Sponsor

Zhongnan Hospital

Enrollment

96 participants

Start Date

Mar 6, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • age ≥ 18 years
  • 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
  • Oxygenation index (PaO₂/FiO₂) ≤ 300
  • Currently receiving invasive mechanical ventilation and expected to require mechanical ventilation for ≥ 48 hours
  • Written informed consent provided by the patient's family member or legally authorized representative

Exclusion Criteria7

  • Presence of severe hemodynamic instability (norepinephrine dose > 0.5 μg/kg/min)
  • Markedly elevated intracranial pressure (> 25 mmHg) or a condition requiring strict intracranial pressure control
  • Untreated tension pneumothorax or undrained mediastinal emphysema
  • Unstable chest wall, flail chest, recent thoracic surgery, or severe thoracic spine injury
  • Pregnant or breastfeeding women
  • Inability to place the EIT chest belt (e.g., open thoracic surgical wounds or skin lesions at the belt placement site)
  • Concurrent participation in another clinical trial

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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.

DEVICEusual care

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.


Locations(1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

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NCT07453966


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