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临床试验/NCT05200507
NCT05200507Unknown不适用

Physiological Effects on Lung Aeration of High Frequency Percussive Ventilation in Hypersecretive Tracheostomized Patients: a Physiological Observational Study

University Magna Graecia1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
15
试验地点
1
主要终点
Lung aeration

研究概览

简要总结

The incidence of pulmonary complications such as pulmonary atelectasis, pneumonia (including ventilator-associated pneumonia), and acute respiratory failure is high in critical care patients. The incidence of ventilator-associated pneumonia can be as high as 27% amongst mechanically ventilated patients. Studies have shown that 16% of critically ill patients have been reported to develop acute respiratory failure, which is associated with prolonged intensive care unit stay, resulting in significantly higher mortality than non-respiratory failure patients. Increased morbidity and mortality contribute to the burden on the health care system and lead to poor health-related outcomes. Multimodal physiotherapy plays a role in the management of these critically ill patients. High frequency percussive ventilation (HFPV) is used in patients with underlying pulmonary atelectasis, excessive airway secretions, and respiratory failure. HFPV is a non-continuous form of high-frequency ventilation delivered by a pneumatic device that provides small bursts of sub-physiological tidal breaths at a frequency of 60-600 cycles/minute superimposed on a patient's breathing cycle. The high-frequency breaths create shear forces causing dislodgement of the airway secretions. Furthermore, the HFPV breath cycle has an asymmetrical flow pattern characterized by larger expiratory flow rates, which may propel the airway secretions towards the central airway. In addition, the applied positive pressure recruits the lung units, resulting in a more homogeneous distribution of ventilation and improved gas exchange. In acute care and critical care settings, HFPV intervention is used in a range of patients, from spontaneously breathing patients to those receiving invasive mechanical ventilation where HFPV breaths can be superimposed on a patient's breathing cycle or superimposed on breaths delivered by a mechanical ventilator. The most common indications for HFPV use are reported as removal of excessive bronchial secretions, improving gas exchange, and recruitment of atelectatic lung segments. This study aims to assess the lung physiological response to HFPV in terms of aeration and ventilation distribution.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • more than 48 hours of invasive mechanical ventilation
  • presence of tracheostomy
  • need for two or more broncoaspirations per hour in the previous 8 hours

排除标准

  • life threatening cardiac arrythmia
  • pneumothorax
  • acute spinal injury
  • chest trauma
  • brain injury in the previous 15 days
  • hemodynamic instability
  • chest or abdominal surgery in the previous 7 days
  • pregnancy
  • enrollment in other study protocols

结局指标

主要结局

Lung aeration

时间窗: Three hours after the end of HFPV application

To evaluate if the application of High Frequency Percussive Ventilation (HFPV) will modify the lung aeration (as assessed by the end-expiratory lung impedance through EIT), as compared to baseline before the treatment

次要结局

  • Arterial Blood Gases(Three hours after the end of HFPV application)

研究者

发起方
University Magna Graecia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Federico Longhini

Prof

University Magna Graecia

研究点 (1)

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