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临床试验/NCT03936231
NCT03936231Unknown不适用

ASSESSMENT OF THE MECHANICAL POWER TRANSMITTED TO THE PATIENTS WITH MECHANICAL VENTILATION IN INTENSIVE CARE UNITS "MECHANICAL POWER DAY"

Hospital Universitario Marqués de Valdecilla1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2019年11月21日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
2,000
试验地点
1
主要终点
Mechanical Power (MP) (assess the amount of energy per minute that is transferred to the lung by the ventilator)

研究概览

简要总结

Recently the new concept of "mechanical power" has been proposed. It refers to the amount of energy per minute that is transferred to the lung by the ventilator. The generation of this form of energy would include both parameters that were previously proposed to be possible causes for lung damage and new parameters that had not been taken into account until now, such as the flow rate or the respiratory rate, without forgetting the individual characteristics of each ventilated subject.

The main objective of the current study is to know the value of the mechanical power in the patient connected to mechanical ventilation, in a volume control model.

This value will be calculated from electronically provided data using the simplified formula by Gattinonni et. al.

详细描述

Introduction and justification:

Over the last few years the investigators have witnessed an important technological developement in the field of mechanical ventilation. Along with the technological advances, the better understanding of the respiratory physiopathology has shown that mechanical ventilation "per se" can lead to deleterious effects.

In this context, the search for those variables which are responsible for the developing of ventilator-induced lung injury (VILI) has become an important goal in this field. In fact, the investigators are witnessing the nearly exponential increase in the publication of studies that have tried to associate the different parameters that intervene in mechanical ventilation with the injury to the lung structure.

Recently the new concept of "mechanical power" has been proposed. It refers to the amount of energy per minute that is transferred to the lung by the ventilator. The generation of this form of energy would include both parameters that were previously proposed to be possible causes for lung damage and new parameters that had not been taken into account until now, such as the flow rate or the respiratory rate, without forgetting the individual characteristics of each ventilated subject.

12J/min has been stablished experimentally as the energy threshold from where changes in the lung that can lead to VILI begin to appear. Nevertheless, the true issue would be to get to know the best way to normalize the mechanical power value. However, it seems reasonable to think that the values of energy originating VILI in experimental animal models and in humans are different.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • Patiens with mechanical ventilation in the critical care areas.

排除标准

  • Patients with not mechanical ventilation.
  • Patients with mechanical ventilation for less that 6 hours.
  • Traqueostomy patients
  • APRV or BiLEVEL ventilation mode.
  • Noninvasive ventilation d.n selectiv
  • Selective ling ventilation

结局指标

主要结局

Mechanical Power (MP) (assess the amount of energy per minute that is transferred to the lung by the ventilator)

时间窗: One Day

MP=0.098 x Vt x Fr x Pp-(Pplat-PEEP/2)

次要结局

未报告次要终点

研究者

发起方
Hospital Universitario Marqués de Valdecilla
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alejandro Gonzalez Castro

Critical Care Department

Hospital Universitario Marqués de Valdecilla

研究点 (1)

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