Effects of Noninvasive Ventilation Compared to Salbutamol
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      Most recently the bronchodilator effect of CPAP mediated by autonomic receptors stretch lung.
      What we need to know is the effect of non-invasive ventilation with two levels of pressure
      can in addition to trigger this neural reflex, can still promote a kinematics similar to
      produced by bronchodilator seen through optoelectronics plethysmography (OEP).

      The Optoelectronics Plethysmography (OEP) has made possible the exploitation of
      Thoracoabdominal movement by magazines, reporting especially changes in total volume of the
      chest wall during any intervention as the NIV.

      The OEP is an innovative method of indirect measurement of pulmonary ventilation, and your
      application can be used in different health conditions, like asthma and neuromuscular
      diseases, with different protocols. Is a non-invasive method and measurement of non-ionizing
      lung volumes, able to detect small movements of the chest wall during breathing through the
      analysis of reflective markers attached to the chest wall of the individual; There is no need
      to use mouthpiece, nasal clip or other connector of the equipment to the individual; the
      calibration is fast and without the participation of the subject.

      Since the NIV with bi-level pressure promotes a level of inspiratory pressure that increases
      the expiratory ventilation and a stretch of lung receptors stimulates and bronchodilator
      effect, the hypothesis of this study is that the thoracic and abdominal configuration and
      improvement of pulmonary function after test of bronchial provocation test is considerable
      with the NIV compared to bronchodilator. There are no studies in the literature that discuss
      this subject under this optics of assessment.

      The aim of this study is to evaluate the effects of the NIV in reversal of bronchial
      provocation test and your potential bronchodilator effect compared to the gold standard
      bronchodilator drug seen by thoracic and abdominal and lung function configuration.

      2. General Purpose

      To evaluate the responses of the thoracoabdominal configuration and the participation of the
      thoracic and abdominal compartments in asthmatic patients before the bronchoprovocation test
      and in response to pharmacological and non-pharmacological therapy.

      2.1. Specific objectives

        -  To evaluate the abdominal thoracic configuration of adolescents and young adults with
           stable asthma before and after bronchoprovocation

        -  To evaluate the effect of bronchodilator and NIV in the thoraco-abdominal configuration

           3. Materials and Methods

      3.1. Kind of study

      This is a randomized, crossover clinical trial in which it will be performed in two visits
      and evaluated the abdominal thoracic configuration before and after bronchoprovocation and
      after bronchodilator and non-invasive ventilation (NIV) with two levels of pressure in
      adolescents and young adults with asthma.

      3.2. Ethical aspects

      This study will be developed respecting the research standards involving human beings
      (Resolution CNS 466/2012) of the National Health Council, was approved by the Research Ethics
      Committee of the University Nove de Julho (2.130.007 / 2017). You will have your registration
      done at clincaltrial.gov.

      3.3. Place of study and sample

      The study will be developed in the Multidisciplinary Laboratory of Movement, Optical
      Electronic Plethysmography (OEP) and in the Functional Respiratory Evaluation Laboratory
      located at the Latin American Memorial Campus of the University of Nove de Julho (UNINOVE),
      at Francisco Matarazzo Avenue, 376, Barra Funda , Sao Paulo-SP.
    

Intervention name(s): Bilevel; Albuterol
Intervention type(s): Device; Drug
Intervention description(s): Basal respiratory mechanics in spontaneous breathing will be analyzed by optoeletronic plethismography (OEP), followed by bronchial provocation with hypertonic saline solution 4.5%, another 45-second OEP uptake, IPAP 12 and EPAP 8 bilevel applied for 10 minutes, and a new uptake. All abstractions are preceded by a forced and slow spirometry maneuver. The entire procedure takes 1 hour.; Basal respiratory mechanics in spontaneous breathing will be analyzed by optoeletronic plethismography (OEP), followed by bronchial provocation with hypertonic saline solution 4.5%, another 45-second OEP uptake, 400 micrograms inhaled Albuterol, and a new uptake. All abstractions are preceded by a forced and slow spirometry maneuver. The entire procedure takes 1 hour.
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma, noninvasive ventilation