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临床试验/NCT02818270
NCT02818270已完成不适用

Evaluation of Aerosolized Drugs Deposition Delivered Through a Mechanical Ventilator

Chang Gung University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Inhaled drug dose

研究概览

简要总结

Aerosol delivery through a ventilator is influenced by numerous factors from ventilator-related, circuit-related to device-related factors. Aerosolized drug delivery through a ventilator system was studied on bench model with albuterol, yet the results were often overestimated. The objective of this study was to evaluate inhaled bronchodilator and mucolytic agents delivered through a ventilator system.

详细描述

Aerosolized medication is used widely to patients with respiratory illness and admitted in the intensive care unit, and includes bronchodilators, steroids, mucolytics, and antibiotics. Aerosol delivery through a ventilator is influenced by numerous factors from ventilator-related, circuit-related to device-related factors. Aerosolized drug delivery through a ventilator system was studied on bench model with albuterol, yet the results were often overestimated. Only few clinical trials on aerosol delivery deposition were published in the last decades. In addition, inhaled bronchodilators, mucolytics, antibiotics, and steroids are often administered to ventilated patients in the intensive care units in Taiwan, but they are never studied. Therefore, the aim of this study was to evaluate inhaled bronchodilator and mucolytics (acetylcystine) delivered by a jet nebulizer through a ventilator system to intubated patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • Mechanical ventilated patients with an endotracheal tube intubated
  • Receiving aerosol therapy with salbutamol or acetylcystine
  • On relatively stable medical condition

排除标准

  • Unstable hemodynamic status (e.g. blood pressure <100/60 mmHg, under Intra-aortic balloon pump)
  • Infected with airborne pathogens (e.g. tuberculosis or Influenza virus)
  • Poor oxygenation (fraction of inspiratory oxygen >0.8, under high frequency oscillatory ventilation, or extracorporeal membrane oxygenation)

研究组 & 干预措施

Drug depositions

Experimental

Aerosol drug deposited delivered on the inhaled and exhaled filters and protective filters were evaluated. Salbutamol and Acetylcysteine were delivered by a jet nebulizer through a mechanical ventilator.

干预措施: Salbutamol (Drug)

Drug depositions

Experimental

Aerosol drug deposited delivered on the inhaled and exhaled filters and protective filters were evaluated. Salbutamol and Acetylcysteine were delivered by a jet nebulizer through a mechanical ventilator.

干预措施: Acetylcysteine (Drug)

结局指标

主要结局

Inhaled drug dose

时间窗: Inhaled drug dose was collected Immediately after each nebulization, expected average of 20 minutes

Drug depositions in inspiratory filters were analyzed by a spectrophotometer.

次要结局

  • exhaled drug dose(Exhaled drug dose was collected Immediately after each nebulization, expected average of 20 minutes)

研究者

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

Hui-Ling Lin

Assistant professor

Chang Gung University

研究点 (1)

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