Quantifying Delivery Of Radio Labeled Aerosol During Noninvasive Ventilation To Stable Moderate And Severe Asthmatics: A Randomized, Cross-Over Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- To compare inhaled dose of radioaerosol into the lungs and determine distribution across horizontal and vertical gradients
研究概览
简要总结
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.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stable moderate to severe asthma (FEV1 > 60% and > 80% and PEF with a variation of 30% from the predicted values to moderate and FVE1 > 60% and );
- •More than one year elapsed since the diagnosis of asthma;
- •None exacerbation in the last six months;
- •Age between 18 - 60 years, from both sexes,
- •Able to understand verbal commands
- •Consent to participate in this protocol.
排除标准
- •presence of dyspnea;
- •smoking history;
- •cardiopulmonary diseases (chronic obstructive pulmonary disease, pneumonia, cardiac failure, myocardial infarction, pneumothorax);
- •hyperthermia;
- •hemodynamic instability (heart rate > 150 bpm and systolic blood pressure < 90 mmHg);
- •arrhythmia absence;
- •pregnancy
- •contraindications for use of noninvasive ventilation
结局指标
主要结局
To compare inhaled dose of radioaerosol into the lungs and determine distribution across horizontal and vertical gradients
时间窗: 10 mouths
Immediately after inhalation, participants sat in a chair with the back positioned in front to the gamma camera (STARCAM 3200 GE, California, USA) to obtain radioactives counts from the posterior thorax during a period of 500 seconds on a matrix of 256 X 256 matrix. After, participants were positioned sitting in front to the gama camera to obtain images from face. Then, the same procedure was performed to analysis deposition in the nebulizer, circuits, inspiratory filter, expiratory filter and face mask. Counts representing stomach were obtained from posterior thorax and corrections for decay of technetium were used to during extrapulmonary measurements.
次要结局
- To quantify mass balance of the delivery system and different compartments, including intrapulmonary and extrapulmonary deposition.(10 mouths)
研究者
Daniella Cunha Brandao
PhD
Universidade Federal de Pernambuco