Asthma Clinical Trial
Official title:
Quantifying Delivery Of Radio Labeled Aerosol During Noninvasive Ventilation To Stable Moderate And Severe Asthmatics: A Randomized, Cross-Over Clinical Trial
Introduction: Inhalation therapy has been established as an efficient route to treat asthma
exacerbations, but coupled to noninvasive ventilation (NIV) remains quite challenging.
Objectives: The aim of this study were to compare radiaoaerosol pulmonary index and
radioaerosol mass balance in the different compartments (pulmonary and extrapulmonary) using
vibrating mesh nebulizers (VMN) and jet nebulizer (JN) coupled to noninvasive ventilation
(NIV).
Material and methods: The investigators assessed 10 stable moderate to severe asthmatics in
a crossover study. Patients was randomly assigned to participate in both phases of the
study: Phase 1(NIV+MN) and phase 2(NIV+JN). DTPA-Tc99m with radioactivity of 25 miC was used
to inhaler using JN positioned in the circuit using a "T" piece, particle size generation in
a five micron range and oxygen flow tritated at eight L/min and MN was positioned in the
mask, particle size generation in a one range and connected to electrical energy. NIV was
used a bilevel pressure through a face mask attached with straps and pressure adjusted were
12 cmH2O and 5 cmH2O as inspiratory and expiratory pressures, respectively. After,
radioactivity counts were performed using a gama camera and regions of interest were
delimited. To calculate aerosol mass balance the investigators considered the amount of
radioaerosol deposited into the lungs, upper airways, stomach, nebulizer, circuit,
inspiratory and expiratory filters, and mask divided for each of these compartments and
represented as a percentage.
n/a
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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