RADIOAEROSSOL PULMONARY DEPOSiTION USING MESH AND JET NEBULIZERS DURING NONINVASIVE VENTILATION IN NORMAL SUBJECTS: A RANDOMIZED CROSSOVER CLINICAL TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Radioaerosol deposition index
研究概览
简要总结
In vivo deposition studies of aerosol administration during noninvasive ventilation are scarce in the current literature.
We assessed 10 normal subjects in a crossover study evaluated by pulmonary scintigraphy aiming to compare radiaoaerosol pulmonary index and radioaerosol mass balance in the different compartments (pulmonary and extrapulmonary) of radiotagged aerosol administered using vibrating mesh nebulizers (VMN) and conventional jet nebulizer (JN) during noninvasive ventilation (NIV).
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No history of lung disease;
- •Forced vital capacity (FVC) or forced expiratory volume in the first second (FEV1) higher or equal to 80% from predicted values (Pereira et al., 1992),
- •No history of smoking;
- •Without respiratory or cardiovascular disease;
- •Ability to understand verbal commands;
- •Willing to provide signed consent to participate in this study.
排除标准
- •Pregnant;
- •Were unable to tolerate NIV (Metha and Hill, 2001).
研究组 & 干预措施
NIV plus jet
Noninvasive ventilation-NIV plus jet nebulizer
干预措施: Jet nebulizer (Other)
NIV plus jet
Noninvasive ventilation-NIV plus jet nebulizer
干预措施: Noninvasive ventilation-NIV (Other)
NIV plus Mesh
Noninvasive ventilation- NIV plus Mesh nebulizer
干预措施: Mesh nebulizer (Other)
NIV plus Mesh
Noninvasive ventilation- NIV plus Mesh nebulizer
干预措施: Noninvasive ventilation-NIV (Other)
结局指标
主要结局
Radioaerosol deposition index
时间窗: 4 m
Inhalation was performed using diethilene triamine penta-acetic technetium (99mTc-DTPA) with radioactivity of 25 millicuries (Nobre et al., 2007). Both nebulizers were charged with 2.5 mg of salbutamol and 0.25 mg of ipratropium bromide and normal saline solution to complete a fill volume of 3 mL. The JN (Misty Max, Air Life, Yorba Linda, USA) with a particle MMAD of 5 µm (according to the manufacturer information) was positioned in the circuit using a "T" piece placed between the circuit leak and the mask, and operated with oxygen flow at 8 L/min. VMN (NIVO, Respironics®, Murrysville, Pennsylvania, USA) with an MMAD of 3.0 µm was placed in the elbow adapter at the mask.
次要结局
- Radioaerosol mass balance in pulmonary and extrapulmonary compartments(4 m)
研究者
Daniella Cunha Brandao
PhD
Universidade Federal de Pernambuco