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

Официальное название

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

Обзор

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

Вмешательства

• Устройство 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.
• Устройство usual care
  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.

Первичные конечные точки

• Time to successful liberation from invasive mechanical ventilation within 28 days after randomization [Срок оценки: 28 days after randomization]

Вторичные конечные точки (12)

• arterial oxygen partial pressure [Срок оценки: Before the first treatment (T0) and after 5-day treatment (T3)]
• cough peak expiratory flow [Срок оценки: Before the first treatment (T0) and after 5-day treatment (T3)]
• Weaning success rate [Срок оценки: From randomization to successful weaning, assessed up to 28 days]
• ICU length of stay [Срок оценки: Follow-up assessments were conducted 1 month after hospital discharge (30 ± 7 days), using the date]
• Hospital length of stay [Срок оценки: 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. [Срок оценки: Before the first treatment (T0), after 5 consecutive days of treatment (T3)]
• Ichikado Score [Срок оценки: Before the first treatment (T0), after 5 consecutive days of treatment (T3)]
• Incidence of MetaNeb-Related Adverse Events [Срок оценки: From the first intervention session (T0) until 24 hours after the last MetaNeb treatment, up to 5 days.]
• tidal impedance variation (TIV) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: Before the first treatment (T0), immediately after the first treatment (T1), 30min after the first treatment (T2), and after 5-day treatment (T3)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Zhongnan Hospital of Wuhan University — Ухань

Идентификаторы

NCT: NCT07453966 · 2025400

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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