临床试验/NCT07453966

NCT07453966招募中不适用

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

Zhongnan Hospital1 个研究点分布在 1 个国家目标入组 110 人开始时间: 2026年3月6日最近更新: 2026年8月12日

适应症

干预措施

试验速览

阶段: 不适用
状态: 招募中
发起方
入组人数: 110
试验地点: 1
主要终点: Duration of mechanical ventilation

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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.

排除标准

•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;
•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.

研究组 & 干预措施

Intrapulmonary percussion ventilation

Experimental

干预措施: usual care (Other)

Intrapulmonary percussion ventilation

Experimental

干预措施: Intrapulmonary percussion ventilation (Device)

usual care

Active Comparator

干预措施: usual care (Other)

结局指标

主要结局

Duration of mechanical ventilation

时间窗: 48 hours after weaning

次要结局

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)
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.(Before the first treatment (T0), after 5 consecutive days of 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))
Ichikado Score(Before the first treatment (T0), after 5 consecutive days of treatment (T3))
Incidence of MetaNeb-Related Adverse Events(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))
ventilation/perfusion (V/Q)(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))
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))

研究者

发起方

Zhongnan Hospital

申办方类型

Other

责任方

Principal Investigator

主要研究者

ZhiYong Peng

Chief physician

Zhongnan Hospital

研究点 (1)

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