Comparison of Lung Deposition With the Aeroneb Solo Adapter and a Standard Jet Nebulizer by SPECT-CT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Pulmonary deposition
研究概览
简要总结
Aeroneb Solo Adapter is a vibrating-mesh nebulizer Aeroneb Solo combined to a spacer specifically designed for spontaneously breathing patients. This device has not been investigated in vivo yet.
It's known that using a spacer during nebulization improves aerosol delivery. We hypothetized that lung deposition could be highly increased with the Aeroneb Solo Adapter in comparison to a standard jet nebulizer.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy respiratory function
排除标准
- •Pulmonary disease
研究组 & 干预措施
Aeroneb Solo Adapter
Subjects inhaled radiolabelled aerosol via the Aeroneb Solo Adapter
干预措施: Technetium-99m - Diethylenetriaminepentaacetic acid (Drug)
Aeroneb Solo Adapter
Subjects inhaled radiolabelled aerosol via the Aeroneb Solo Adapter
干预措施: Aeroneb Solo Adapter (Device)
Aeroneb Solo Adapter
Subjects inhaled radiolabelled aerosol via the Aeroneb Solo Adapter
干预措施: Planar scintigraphy (Other)
Aeroneb Solo Adapter
Subjects inhaled radiolabelled aerosol via the Aeroneb Solo Adapter
干预措施: Single photon emission computed tomography (Other)
Aeroneb Solo Adapter
Subjects inhaled radiolabelled aerosol via the Aeroneb Solo Adapter
干预措施: Spirometry (Other)
Standard Jet Nebulizer
Subjects inhaled radiolabelled aerosol via a standard jet nebulizer, the Opti-Mist Plus Nebulizer
干预措施: Technetium-99m - Diethylenetriaminepentaacetic acid (Drug)
Standard Jet Nebulizer
Subjects inhaled radiolabelled aerosol via a standard jet nebulizer, the Opti-Mist Plus Nebulizer
干预措施: Opti-Mist Plus Nebulizer (Device)
Standard Jet Nebulizer
Subjects inhaled radiolabelled aerosol via a standard jet nebulizer, the Opti-Mist Plus Nebulizer
干预措施: Planar scintigraphy (Other)
Standard Jet Nebulizer
Subjects inhaled radiolabelled aerosol via a standard jet nebulizer, the Opti-Mist Plus Nebulizer
干预措施: Single photon emission computed tomography (Other)
Standard Jet Nebulizer
Subjects inhaled radiolabelled aerosol via a standard jet nebulizer, the Opti-Mist Plus Nebulizer
干预措施: Spirometry (Other)
结局指标
主要结局
Pulmonary deposition
时间窗: immediately after nebulization by imaging assessment, an expected average of 15 minutes
Planar scintigraphy and single photon emission computed tomography as imaging techiques
次要结局
- Three-dimensional penetration index(immediately after the nebulization by imaging assessment, expected average of 30 minutes)