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临床试验/NCT03430505
NCT03430505已完成不适用

Effects of Noninvasive Ventilation Compared to Salbutamol in Respiratory Mechanics and Lung Function of Asthmatics After Bronchoprovocation: Randomized Cross-over Trial

University of Nove de Julho1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年6月10日最近更新:
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
FEV1

研究概览

简要总结

Asthma is a chronic inflammatory disease characterized by recurrent and reversible episodes of airway obstruction. Drug treatment usually includes inhaled corticosteroids and bronchial dilators, which often do not have adequate adherence. These acute episodes of bronchoconstriction can most often occur with hyperinflation and for decades the mechanisms that lead to hyperinflation have been studied, as well as increasingly modern ways of evaluating and treating these mechanisms. Noninvasive ventilation is increasingly occupying its space as a non-pharmacological resource in the treatment of asthma, initially as an adjunct in an attempt to help medication have its effect reached in the crisis, but this feature has been showing signs of having an even greater action which can even collaborate in reversing the crisis by not only giving time for pharmacological action. Recognizing these potential effects of this widely used resource and understanding its action on lung function and the reversal of exacerbation is part of this scientific process.

详细描述

Asthma is a chronic inflammatory disease characterized by recurrent episodes of reversible airway obstruction. The drug treatment typically includes inhaled steroids and bronco dilators. These acute episodes of bronchoconstriction can, for the most part, attend with hyperinflation, the hyperinflation and the consequent increase of functional residual capacity (FRC) inspiratory muscle activation in phase before the expiratory lung elastic equilibrium and rib cage.

Some studies reports the injury to respiratory function that causes acute hyperinflation with a reduction of the contribution of the abdominal compartment and increased assistance from the chest compartment, thereby reducing the efficiency mechanics of the diaphragm in response to decreased your stamping area. As a result of this disadvantage and mechanics "reduction of curvature" of the diaphragm expiratory muscle activation occurs in an attempt to restore the original mechanics and thus your primary function.

Some studies have investigated the effects of bronchoconstriction in recruitment of the respiratory muscles and respiratory mechanics of patients susceptible to asthma. As asthma has distinct characteristics in crisis and in stable phase, testing of bronchial provocation test have been part of the studies allowing assessment in different physiological conditions, close to an acute condition without necessarily a crisis and insufficiency that would make it really an assessment respiratory kinematics and the involvement of the thoracic and abdominal compartments in each of these phases and mainly in front of any therapy.

Bronchial provocation tests are safe once they cause the release of endogenous mediators that cause the bronchial smooth muscle contraction causing narrowing of the airway, but as your sensitivity is reduced your action is completely reversed with use of bronchodilator and the positive response to these tests that can be performed by exercise or inhaling hypertonic solution 4.5% reflect a inflammation of the Airways.

The interest in the implementation of non-pharmacological therapies and especially the knowledge of resources used often to relieve the overload of respiratory muscles in patients with obstructive, since the Decade of 80, has been demonstrating that the use of expiratory positive pressure can reduce muscle work and reduce the volume of expiratory reserve contributing to deflation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
12 Years 至 29 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Bilevel

Active Comparator

Bilevel 10 minutes after bronchoprovocation with saline solution 4.5%. IPAP 12 and EPAP 8

干预措施: Bilevel (Device)

Albuterol

Active Comparator

400micrograms after bronchoprovocation with saline solution 4.5%.

干预措施: Albuterol (Drug)

结局指标

主要结局

FEV1

时间窗: Change from baseline FEV1 at 1 hour

Spirometry

Expiratory time

时间窗: Change from baseline expiratory time at 1 hour

Optoeletronic Plethismography

Inspiratory Capacity

时间窗: Change from baseline IC at 1 hour

Spirometry

次要结局

  • Minute Volume(Change from baseline minute volume at 1 hour)

研究者

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

Evelim Leal de Freitas Dantas Gomes, PT

Clinical Professor

University of Nove de Julho

研究点 (1)

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