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

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

Study Overview

• Status: Recruiting
• Conditions: Pneumonia
• Intervention / Treatment: Device: Intrapulmonary percussion ventilation; Other: usual care

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qingting Xie; Phone Number: +86 13296652698; Email: qingtingxxx@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430071
      • Recruiting
      • Zhongnan Hospital of Wuhan University
      • Contact: Qingting Xie; Phone Number: +86 13296652698; Email: qingtingxxx@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: usual care	Other: usual 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.
Experimental: Intrapulmonary percussion ventilation	Device: Intrapulmonary 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.; Other Names: continuous high-frequency oscillation; Other: usual 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	From randomization to successful weaning, assessed up to 28 days
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.	Follow-up assessments were conducted 1 month after hospital discharge (30 ± 7 days), using the date
Hospital length of stay	Hospital length of stay was defined as the number of days from hospital admission to discharge or death, calculated as calendar days.	Follow-up assessments were conducted 1 month after hospital discharge (30 ± 7 days), using the date
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.	Score according to the following aspects: body temperature (12 hour average, ℃): 0 point: 36.1-38.4 ℃; 1 point: 38.5-38.9 ℃.; 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.; 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.; oxygenation index (mmHg): 0 point: >240; 2 points: ≤240 without ARDS.; chest X-ray infiltrating shadow: 0 point: no infiltrating shadow; 1 point: patchy infiltrating shadow; 2 points: fusion of patchy infiltrating shadow.; 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.	Before the first treatment (T0), after 5 consecutive days of treatment (T3)
Ichikado Score	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.	Before the first treatment (T0), after 5 consecutive days of treatment (T3)
Incidence of MetaNeb-Related Adverse Events	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.	From the first intervention session (T0) until 24 hours after the last MetaNeb treatment, up to 5 days.
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)

Collaborators and Investigators

• Sponsor: Zhongnan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: February 13, 2026
• First Submitted That Met QC Criteria: March 4, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): August 12, 2026
• Last Update Submitted That Met QC Criteria: August 10, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: mechanical ventilation; Pneumonia; electrical impedance tomography; pulmonary infection; Intrapulmonary percussion ventilation
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: 2025400

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes