Implemental Flutter Mucus Clearance Devices on Geriatric Lung Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- FVC, Forced Vital Capacity
研究概览
简要总结
The purpose of this study is to evaluate the clinical outcome and safety of flutter mucus clearance devices in elders of gerocomium.
详细描述
Respiratory diseases are still increasing in the elderly population. The fluttering mucus clearance technique is expected to be a physical assisting therapy enhancing airway secretion clearance but needs more clinical randomized, controlled trial evidence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 85 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •available to perform the device, the elders in geracomium
- •male and female
- •aging 85 years or more
排除标准
- •not available to perform the procedure
- •untreated pneumothorax
- •diffusion interstitial lung disease
- •acute coronary syndrome
- •third stage hypertension
- •advanced cancer
- •severe heart, liver, renal, blood system and endocrine system dysfunction
- •noninvasive mechanical ventilation
- •active hemoptysis
研究组 & 干预措施
control group
intervention
Intervention group were given flutter valve mucus clearance devices to do pulmonary function exercise
干预措施: flutter mucus clearance device (Device)
结局指标
主要结局
FVC, Forced Vital Capacity
时间窗: up to 28 days
indicators of pulmonary function, for example, FVC(unit of measurement:Liter) All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study.
FEV1/FVC%, the Ratio of FEV1 to FVC
时间窗: up to 28 days
indicators of pulmonary function, All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study.
Number of Cases With Fever (Body Temperature Reach 38 Degree Celsius or Higher)
时间窗: up to 28 days
MPEF,Mean Peak Expiratory Flow
时间窗: up to 28 days
indicators of pulmonary function, for example, PEF(unit of measurement:Liter per minute) All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study.
FEV1, Forced Expiratory Volume at First Second
时间窗: up to 28 days
indicators of pulmonary function, for example, FEV1(unit of measurement:Liter) All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study.
次要结局
- Number of Cases With Antibiotics Therapy(up to 28 days)
- Number of Cases With Hospital Visit(up to 28 days)
研究者
Zhang Xiangyu
MD, director, professor, FCCM, FCCP.
Tongji University