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临床试验/NCT04046380
NCT04046380Unknown不适用

A Modified Mathematical Model to Calculate Power Received by Mechanically Ventilated Patients With Different Etiologies

Changhua Christian Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年8月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
correlation of calculated and measured work of breath

研究概览

简要总结

Ventilator-induced lung injury is a common complication. The latest and most noticeable theory of its pathogenesis is called 'ergotrauma' by Gattinoni in 2016. The theory uses ventilator-imposed 'energy' or 'power' to encompass several known forms of injury-inducing factors such as pressure,volume, flow, rate, etc. However, to quantify power imposed by ventilator is no easy task in clinical practice. So, Gattinoni proposed a mathematical formula for easy power calculation. However, Gattinoni did not compare the difference between various etiologies of acute lung injury. We will enroll 100 patients (50 with acute respiratory distress syndrome and 50 with normal lung). The ventilator-imposed power at various tidal volume (6, 8, 10 ml/Kg) and positive end-expiratory pressure (5, 10 cmH2O) will be calculated by the formula. The area enclosed by hysteresis of pressure-volume curve, and hence the work it implies, will be measured as a standard. Our study will aim to compare the formula in different patient groups and in Taiwanese people.

研究设计

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

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Intubated patients aged 20 to 90 years old

排除标准

  • Fraction of inspired oxygen (FiO2) higher than 60%
  • Acute physiology and chronic health evaluation (APACHE) II score more than 30
  • Plateau pressure or peak airway pressure more than 30 cmH2O
  • High risk for barotrauma
  • Unstable hemodynamic status
  • Under airway pressure release ventilation or high frequency oscillation ventilation therapy
  • Under extra-corporeal membrane oxygenation support
  • On prone position

结局指标

主要结局

correlation of calculated and measured work of breath

时间窗: The measurement and calculation will be performed only once when the ventilator was in use. The estimated time frame of measurement is less than one hour.

The ventilator-imposed power at various tidal volume (6, 8, 10 ml/Kg) and positive end-expiratory pressure (5, 10 cmH 2 O) will be calculated by the formula.

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

Cheng-Deng Kuo

Doctor

Changhua Christian Hospital

研究点 (1)

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