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临床试验/NCT03945409
NCT03945409Unknown不适用

Validation of a New Automated System for Continuous Real-time Monitoring of Transpulmonary Pressure During Invasive Mechanical Ventilation in Patients With Acute Respiratory Failure

University of Milan2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年3月28日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
Measure of transpulmonary pressure (cmH2O).

研究概览

简要总结

Patients admitted to Intensive Care Unit often are affected by acute respiratory failure at admission or during hospital stay, with a mortality of 30%.

Treatment remains largely supportive with mechanical ventilation as the mainstay of management by improving the hypoxemia and reducing the work of breathing; however, the mechanical forces generated during ventilation can further enhance pulmonary inflammation and edema, a process that has been termed ventilator induced lung injury (VILI). Consequently, in clinical practice the lung protective ventilation is mainly based on the reduction of the tidal volume, the airway and the transpulmonary plateau pressure. A good clinical practice is based on the assessment of changes in respiratory mechanics.

Aim of the study is to determine the accuracy of the OPTIVENT system in measuring transpulmonary pressure, comparing it with the systems currently in use in our Operative Unit.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • acute respiratory failure
  • invasive mechanical ventilation.

排除标准

  • haemodynamic instability
  • presence of barotrauma
  • esophageal disease.

结局指标

主要结局

Measure of transpulmonary pressure (cmH2O).

时间窗: Day 1.

Validation of the new system in terms of accuracy and precision. The accuracy of the OPTIVENT system in measuring transpulmonary pressure, comparing it with the systems currently in use, will be assessed by measure of airway and esophageal pressure at the end of an inspiratory and expiratory hold.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Davide Chiumello

Professor

University of Milan

研究点 (2)

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