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RecruitingNCT07453966Updated Aug 12, 2026

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

An interventional study of Intrapulmonary percussion ventilation and usual care in Pneumonia, sponsored by Zhongnan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by Zhongnan Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2026; still recruiting 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Pneumonia

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Keywords

  • Pneumonia
  • Intrapulmonary percussion ventilation
  • mechanical ventilation
  • electrical impedance tomography
  • pulmonary infection
03

In context

Pneumonia

1,564 studies on the registry are indexed under Pneumonia; 265 are open to participants now.

This study's planned enrollment of 110 is below the median of 129 across 975 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Zhongnan Hospital is the lead sponsor of 106 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 provided by the patient's family member or legally authorized representative.

Exclusion criteria

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 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
110 participants (estimated)

Study arms

  • Experimental
    Intrapulmonary percussion ventilation

    Device: Intrapulmonary percussion ventilation · Other: usual care

  • Active comparator
    usual care

    Other: usual care

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.

    Also known as: continuous high-frequency oscillation

  • Otherusual 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.

06

What researchers measure

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

  5. 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.

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

  6. 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: 1. body temperature (12 hour average, ℃): 0 point: 36.1-38.4 ℃; 1 point: 38.5-38.9 ℃. 2. 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. 3. 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. 4. oxygenation index (mmHg): 0 point: \>240; 2 points: ≤240 without ARDS. 5. chest X-ray infiltrating shadow: 0 point: no infiltrating shadow; 1 point: patchy infiltrating shadow; 2 points: fusion of patchy infiltrating shadow. 6. 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.

    Time frame: Before the first treatment (T0), after 5 consecutive days of treatment (T3)

  7. 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.

    Time frame: Before the first treatment (T0), after 5 consecutive days of treatment (T3)

  8. 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.

    Time frame: From the first intervention session (T0) until 24 hours after the last MetaNeb treatment, up to 5 days.

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. arterial carbon dioxide partial pressure

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

  16. arterial oxygen saturation

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

  17. blood lactic acid

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

  18. PaO₂/FiO₂

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

  19. 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)

  20. 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)

  21. 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)

  22. 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)

  23. 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)

  24. 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)

  25. 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)

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Mar 2027, 11 months after the start.

Of 258 non-industry interventional studies with no phase under Pneumonia, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 31. This study's planned 11 months is below that.

Counting every sponsor, half of 265 studies reached it within 21 months; a quarter within 10 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 13, 2026
First posted
Mar 6, 2026
StartActual
Mar 6, 2026
Primary completionEst.
Mar 1, 2027
CompletionEst.
May 1, 2027
Last update
Aug 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07453966
Lead sponsor
Zhongnan Hospital
Responsible party
ZhiYong Peng (Chief physician, Zhongnan Hospital) — Principal investigator
First posted
Mar 6, 2026
Start date
Mar 6, 2026
Primary completion
Mar 1, 2027 (estimated)
Completion
May 1, 2027 (estimated)
Last update
Aug 12, 2026

Study contacts

Qingting Xie
Contact
qingtingxxx@163.com
+86 13296652698

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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