Short-term Apnoea Training With Deep Inspiration Breath Hold vs High Frequency Percussive Ventilation for Apnoea-like Suppression of Respiratory Motion: a Pilot Study Using Magnetic Resonance Imaging at 1.5T Assessing Their Application for Proton Therapy Treatment of Lung Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Difference in MRI Images
研究概览
简要总结
Since 1996 proton therapy has been applied very successfully at the Paul Scherrer Institute in Switzerland to irradiate deep-seated, stationary tumors. In order to treat tumors within an organ which moves due to breathing (e.g. lung) motion mitigation strategies need to be implemented to ensure the precise irradiation of the moving target. The aim of this study is to assess the feasibility and compare (via MRI imaging) 2 techniques which "freeze" the movement of the lung by breath hold. One method is suppression of respiratory movement via high-frequency, mechanical ventilation by means of a Jet Ventilator (HFPV). The other technique is deep Inspiration breath-hold (DIBH) with Hyperventilation and simultaneous Inspiration of 100% O2 including daily breath-hold exercise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ability to give informed consent by signature
- •healthy, i.e. normal physical and mental status
排除标准
- •contraindications to MRI (non-MRI-suitable electronical & metal implants, claustrophobia)
- •women who are pregnant or are breast feeding
- •acute or chronic illness
- •known or suspected non-compliance, drug or alcohol abuse
- •inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- •presence of any psychological or sociological condition potentially hampering compliance with the study protocol
研究组 & 干预措施
Deep Inspiration Breath Hold (DIBH)
DIBH extended by prior hyperventilation while breathing 100% O2
干预措施: Deep Inspiration Breath Hold (DIBH) (Other)
High Frequency Percussive Ventilation (HFPV)
passive Ventilation by a jet ventilator
干预措施: High Frequency Percussive Ventilation (HFPV) (Other)
结局指标
主要结局
Difference in MRI Images
时间窗: 3 weeks
pulmonary anatomical structure points are evaluated by means of MRI scans. The difference of these MRI evaluations between the DIBH- and HFPV-technique is the primary outcome measure.
次要结局
- Difference in breath-hold duration(3 weeks)