Effect of Introducing a Positive Expiratory Pressure Device During Inhalation of Hypertonic Saline in Patients With Cystic Fibrosis: a Randomized Crossover Trial.
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
- Wet sputum production
研究概览
简要总结
This trial aims to analyze whether the inhalation of hypertonic saline combined with a positive expiratory pressure (PEP) device increases the amount of sputum expectorated during the chest physiotherapy session ( inhalation + bronchial drainage).
详细描述
All patients will perform two different arms of treatment in a crossover randomization. Each arm of treatment will be applied during 5 consecutive days. The wash-out period will be one week. Before starting the trial all patients will do an inhalation formation.
During the study period the patients' pharmacological treatment remains unchanged
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pass the inhalation test
- •Chronic sputum production, at least ≥ 10 ml /24h
- •Cystic Fibrosis (CF) diagnosed ( established by genotype or sweat sodium>70 mmol/l or sweat chloride of>60 mmol/l)
- •Clinically stable at the time of recruitment (defined as no requirement for antibiotics or change in respiratory medication in the preceding 4 weeks)
- •Trained in the use of autogenic drainage technique (at least 6 months)
- •Inhaling hypertonic saline since at least 6 months
- •To be able to provide written, informed consent and perform the protocol and the evaluations
排除标准
- •Active massive hemoptysis during the previous 2 months
- •Patient in transplantation or retransplantation list
- •Patient already participating in another study at the same time
研究组 & 干预措施
USUAL CARE
Patients will perform the inhalation of the 7% hypertonic saline (following the gold standard recomendation) during 15 minutes. Right after, patients will perform independently their usual session of autogenic drainage during 30 minutes.
INHALATION WITH PEP DEVICE
Patients will perform the inhalation of the 7% hypertonic saline (following the gold standard recomendation) combined with a PEP device (Acapella Duet) during 15 minutes. Right after, patients will perform independently their usual session of autogenic drainage during 30 minutes.
干预措施: INHALATION WITH PEP DEVICE (Acapella Duet) (Device)
结局指标
主要结局
Wet sputum production
时间窗: 45 minutes
Wet sputum production (ml) during chest physiotherapy session (inhalation + bronchial drainage)
次要结局
- Lung function (simply spirometry)(5 days)
- Patient's perception (Likert test)(5 days)
- Questionnaire(5 days)
- Wet sputum production(22 hours)
- Safety and tolerability of session (Pulse-oximetry, heart rate, dyspnea, hemoptysis, cough, throat irritability and saltiness, heart rate)(45 minutes)
- Wet sputum production(2 hours)