Establishment and Implementation of Nebulised High Volumes of Hypertonic Saline in Cystic Fibrosis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Tolerance and safety of high volumes of inhaled hypertonic saline measured by forced expiratory volume at one second
研究概览
简要总结
Background Nebulised hypertonic saline (HS) is an established basic airway clearance treatment in Cystic Fibrosis (CF). However, there is scarce evidence regarding the practical implementation and administration of different HS volumes, including physiotherapy and aspects of breathing pattern.
The aim of the study was to implement standardised and age-adjusted nebulised volumes of hypertonic saline in cystic fibrosis patients, included in physiotherapy and lung drainage techniques.
详细描述
Aims: To establish a safe, efficient routine for implementation of HS in daily treatment and to investigate the efficiency and tolerance of high volumes of HS integrated with chest physiotherapy.
HS was given twice daily with volumes of 4,5 ml in children aged 0-5 years, 6 ml at age 6-16 years and 9 ml at age > 16 years. The protocol included guidance of standardized breathing pattern, upright and sideways positioning and voluntary cough.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cystic fibrosis
排除标准
- •Non-adherence
结局指标
主要结局
Tolerance and safety of high volumes of inhaled hypertonic saline measured by forced expiratory volume at one second
时间窗: 24 months
次要结局
- Implementation of nebulised high volumes of hypertonic saline in cystic fibrosis patients(24 months)