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

NCT07453966 | Recruiting FDA Device

• 1 other identifier: 2025400
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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

Conditions

Pneumonia

Keywords

Pneumonia; Intrapulmonary percussion ventilation; mechanical ventilation; electrical impedance tomography; pulmonary infection

Outcome Measures

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.

  28 days after randomization

Secondary Outcomes (25)

• 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

• ICU length of stay

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

• Hospital length of stay

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

Study Arms (2)

Intrapulmonary percussion ventilation

EXPERIMENTAL

Device: Intrapulmonary percussion ventilation

usual care

ACTIVE COMPARATOR

Device: usual care

Interventions

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.

Also known as: continuous high-frequency oscillation

Intrapulmonary percussion ventilation

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.

usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years;
• 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.
• Oxygenation index (PaO₂/FiO₂) ≤ 300;
• Currently receiving invasive mechanical ventilation and expected to require mechanical ventilation for ≥ 5 days;
• Written informed consent provided by the patient's family member or legally authorized representative.

You may not qualify if:

• 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 or untreated tension pneumothorax or undrained mediastinal emphysema;
• Active massive hemoptysis;
• Severe bronchospasm with inability to tolerate fluctuations in airway pressure;
• Unstable chest wall, flail chest, recent thoracic surgery, or severe thoracic spine injury;
• Receiving extracorporeal membrane oxygenation (ECMO);
• 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.

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

RECRUITING

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Qingting Xie

CONTACT

+86 13296652698; qingtingxxx@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: March 6, 2026
• Study Start: March 6, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)