Non-Invasive Respiratory Monitor
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Breathing rate
研究概览
简要总结
This study will clinically evaluate a newly developed respiratory monitor - pneuRIP. The pneuRIP uses Respiratory Inductance Plethysmography (RIP) bands to measure key breathing indices non-invasively. This study compares the pneuRIP to an existing Respitrace system (Carefusion, Yorba Linda CA). 10 normal children and 10 children with breathing difficulties will be monitored with both systems.
详细描述
Firstly, ten healthy children will participate in a trial to evaluate the pneuRIP. They will be fitted with the bands around their abdomen and chest. The pneuRIP will be connected to the bands through electrodes. Breathing is then measured wirelessly with an iPad. They will be asked to lie down. They are asked to breath normally then asked to breath with a resistive elements to place in their mouth. The resistive elements makes it difficult to breath (similar to breathing through a straw). They will breathe for 3 minutes for both conditions as we record their breathing with the pneuRIP and the Respitrace. These data will be compared.
Secondly, A group of 10 subjects from the outpatient muscle clinic will be fitted with the chest and abdomen bands. The Respitrace monitor and the pneuRIP will record their breathing patterns. Data from the two systems will then be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •Neuromuscular disease subjects with mild breathing difficulty
- •Capable of following verbal instructions
排除标准
- •Severe breathing difficulties
研究组 & 干预措施
pneuRIP(breathing with resistance)
Testing the subjects breathing with resistance
干预措施: pneuRIP (breathing with resistance) (Device)
pneuRIP(breathing with resistance)
Testing the subjects breathing with resistance
干预措施: Respitrace system (Carefusion) (breathing without resistance) (Device)
Respitrace system (Carefusion) (breathing without resistance)
Testing subjects breathing without resistance
结局指标
主要结局
Breathing rate
时间窗: Immediately after test
The breathing rate is measured by two different monitors
次要结局
- Phase Difference(Immediately after test)
- Labored breathing Index(Immediately after test)
- Percent rib cage(Immediately after test)
研究者
Tariq Rahman
Principal Research Engineer
Nemours Children's Clinic