PneumoniaNCT07453966
Efficacy and Safety of Intrapulmonary Percussive Ventilation in Patients With Pulmonary Infection Receiving Invasive Mechanical Ventilation
A study testing Intrapulmonary percussion ventilation in people with Pneumonia, run by Zhongnan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- Intrapulmonary percussion ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 6 Mar 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- Receiving analgesia and sedation;
- Written informed consent provided by the patient's family member or legally authorized representative.
Who cannot join
- 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;
- Active massive hemoptysis;
- Severe bronchospasm or inability to tolerate fluctuations in airway pressure;
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- Inability to place the EIT chest belt, such as open thoracic surgical wounds or skin lesions at the belt placement site;
- Receiving extracorporeal membrane oxygenation (ECMO);
- Acute exacerbation of chronic obstructive pulmonary disease as the primary reason for the current episode of invasive mechanical ventilation;
- Expected death within 24 hours, or a decision already made to withhold or withdraw life-sustaining treatment;
- Pregnancy or breastfeeding;
- Concurrent participation in another clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Qingting Xie, +86 13296652698, qingtingxxx@163.com
About this study
Official title: 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:
Read more
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
- Being tested
- Intrapulmonary percussion ventilation, usual care
- Keywords
- Pneumonia, Intrapulmonary percussion ventilation, mechanical ventilation, electrical impedance tomography, pulmonary infection
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrapulmonary percussion ventilationDevice
Also called continuous high-frequency oscillation
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 careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intrapulmonary percussion ventilation | Experimental | Not described Receives: Device: Intrapulmonary percussion ventilation; Other: usual care |
| usual care | Active comparator | Not described Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days after randomization
Secondary outcomes (25)
arterial oxygen partial pressure
Measured: Before the first treatment (T0) and after 5-day treatment (T3)
cough peak expiratory flow
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the first intervention session (T0) until 24 hours after the last MetaNeb treatment, up to 5 days.
tidal impedance variation (TIV)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Before the first treatment (T0) and after 5-day treatment (T3)
arterial oxygen saturation
Measured: Before the first treatment (T0) and after 5-day treatment (T3)
blood lactic acid
Measured: Before the first treatment (T0) and after 5-day treatment (T3)
PaO₂/FiO₂
Measured: Before the first treatment (T0) and after 5-day treatment (T3)
heart rate
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: Before the first treatment (T0), immediately after the first treatment (T1), 30min after the first treatment (T2), and after 5-day treatment (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start6 Mar 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZhiYong Peng, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453966
- Sponsor's protocol ID
- 2025400
- Status last verified
- Aug 2026
- First submitted
- 13 Feb 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07453966
- Acronym / sponsor ID
- 2025400
- Conditions
- Pneumonia
- Keywords
- Pneumonia, Intrapulmonary percussion ventilation, mechanical ventilation, electrical impedance tomography, pulmonary infection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 6 Mar 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrapulmonary percussion ventilation | Experimental | Device: Intrapulmonary percussion ventilation, Other: usual care |
| usual care | Active comparator | Other: usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
- Receiving analgesia and sedation;
Key exclusion criteria (12 listed)
- 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;
- Active massive hemoptysis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrapulmonary percussion ventilationAlso: continuous high-frequency oscillationIn 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. | Device | Intrapulmonary percussion ventilation |
| usual careParticipants 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. | Other | Intrapulmonary percussion ventilation, usual care |
Primary outcome
Time to successful liberation from invasive mechanical ventilation within 28 days after randomization
Time frame: 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.
25 secondary outcomes
arterial oxygen partial pressure
Time frame: Before the first treatment (T0) and after 5-day treatment (T3)
cough peak expiratory flow
Time frame: Before the first treatment (T0) and after 5-day treatment (T3)
Weaning success rate
Time frame: From randomization to successful weaning, assessed up to 28 days
ICU length of stay
Time frame: Follow-up assessments were conducted 1 month after hospital discharge (30 ± 7 days), using the date
Hospital length of stay
Time frame: 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.
Time frame: Before the first treatment (T0), after 5 consecutive days of treatment (T3)
Ichikado Score
Time frame: Before the first treatment (T0), after 5 consecutive days of treatment (T3)
Incidence of MetaNeb-Related Adverse Events
Time frame: From the first intervention session (T0) until 24 hours after the last MetaNeb treatment, up to 5 days.
tidal impedance variation (TIV)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Before the first treatment (T0) and after 5-day treatment (T3)
arterial oxygen saturation
Time frame: Before the first treatment (T0) and after 5-day treatment (T3)
blood lactic acid
Time frame: Before the first treatment (T0) and after 5-day treatment (T3)
PaO₂/FiO₂
Time frame: Before the first treatment (T0) and after 5-day treatment (T3)
heart rate
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Before the first treatment (T0), immediately after the first treatment (T1), 30min after the first treatment (T2), and after 5-day treatment (T3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrapulmonary percussion ventilation in people with Pneumonia, run by Zhongnan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qingting Xie (+86 13296652698, qingtingxxx@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to successful liberation from invasive mechanical ventilation within 28 days after randomization (time frame: 28 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.