Short-term Effects of Positive Expiratory Pressure Mask on Ventilation Inhomogeneity in Children and Adolescents With Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 4
- 主要终点
- Effect of PEP-MASK on ventilation heterogeneity (Sacin)
研究概览
简要总结
Although some studies have brought some evidences about the efficacy of positive expiratory pressure (PEP)-mask therapy as an airway clearance technique, yet it is not clearly understood what is the contribution of this technique in modifying peripheral ventilation inhomogeneity, a typical feature of patients with Cystic Fibrosis (CF).
The aim of this study is to investigate how PEP-MASK affects ventilation inhomogeneity in children and adolescents, with moderate to normal CF lung disease by the change in acinar airways (Sacin), lung clearance index (LCI) and conductive airways (Scond) indexes derived from nitrogen multiple-breath washout test (N2MBW).
详细描述
Investigational device: PEP-MASK=Positive Expiratory Pressure delivered through a face mask.
Standard Operating Procedures used for evaluating CF lung disease and ventilation inhomogeneity.
Sample size: Based on preliminary data collected on seven subjects who performed nitrogen multiple-breath washout test before and after PEP-MASK, assuming a variation of 20% of Sacin, the study requires a sample size of 18 subjects.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Technicians performing multiple-breath washout tests are blinded to treatment allocation; physiotherapists performing the treatment are blinded to multiple breath washout results; patients are blinded to the purpose of the study; the statistician will be blind to treatment allocation together with outcome assessors.
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CF diagnosis
- •Patients hospitalized for a scheduled intravenous antibiotics cycle and regularly followed-up by the CF Centre
- •≥ 15 kilograms
- •FEV1 ≥ 40%predicted
- •Ability to perform NMBW test
- •Ability to perform spirometry
- •Willing to adhere to protocol procedures
- •Patients in treatment with PEP-MASK
排除标准
- •Pulmonary Exacerbation within two last week
- •Burkholderia cepacia infection
- •Patients in lung transplantation waiting list
- •Patients undergoing non invasive mechanical ventilation or oxygen therapy
结局指标
主要结局
Effect of PEP-MASK on ventilation heterogeneity (Sacin)
时间窗: Right after intervention/sham procedure
Acinar airways (Sacin) mean difference between treatments
次要结局
- Effect of PEP-MASK on ventilation heterogeneity (Scond)(Right after intervention/sham procedure)
- Effect of PEP-MASK on ventilation heterogeneity (LCI)(Right after intervention/sham procedure)
- Sputum weight(From the beginning to the end of each intervention/sham procedure)
- Oxygen saturation(From the beginning to the end of each intervention/sham procedure)