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

ConditionPneumonia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhongnan Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years;

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);

Oxygenation index (PaO₂/FiO₂) ≤ 300;

Currently receiving invasive mechanical ventilation, with no planned liberation from invasive mechanical ventilation within the next 24 hours;

Disqualifiers

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;

Severe pulmonary bullae, untreated tension pneumothorax or undrained mediastinal emphysema;

Unstable chest wall, flail chest, recent thoracic or airway surgery, or severe thoracic spine injury;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • usual care

    Other intervention

    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.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Intrapulmonary percussion ventilationExperimental treatment 2 interventions
Group B: usual careActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
28 days after randomization

Secondary outcomes

1

arterial oxygen partial pressure

Time frame
Before the first treatment (T0) and after 5-day treatment (T3)
2

cough peak expiratory flow

Time frame
Before the first treatment (T0) and after 5-day treatment (T3)
3

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.

Time frame
From randomization to successful weaning, assessed up to 28 days
4

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.

Time frame
Follow-up assessments were conducted 1 month after hospital discharge (30 ± 7 days), using the date

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.