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临床试验/NCT03655249
NCT03655249招募中不适用

Effects of Autogenic Drainage on Ventilation Inhomogeneity in Patients With Cystic Fibrosis

Cliniques universitaires Saint-Luc- Université Catholique de Louvain1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Change in Lung Clearance Index

研究概览

简要总结

This study will investigate the effects of a chest physiotherapy manual technique (autogenic drainage) on ventilation inhomogeneity in patients with cystic fibrosis. Lung clearance index (LCI) is the primary outcome

详细描述

This is a cross-over intervention assessing the effect of autogenic drainage on ventilation inhomogeneity in patients with cystic fibrosis.

Electrical impedance tomography and multiple breath nitrogen washout will be performed before, immediatly after and 2h post intervention. Each participant will receive either aerosoltherapy alone or in combination with chest physiotherapy on 2 consecutive days.

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
None

入排标准

年龄范围
6 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cystic fibrosis diagnosis
  • FEV1 > 40%
  • Able to sustain 30min of chest physiotherapy

排除标准

  • Presence of Burkoldheria cepacia or non tuberculous mycobacteria
  • Orthopedic, neuromuscular or cardiac disorder likely to impact respiratory system
  • Need for supplemental oxygen
  • Cardiac pacemaker or internal cardiac defibrillator

研究组 & 干预措施

Asl + CPT

Experimental

Aerosotherapy + Autogenic drainage

干预措施: Autogenic drainage (Other)

Asl + CPT

Experimental

Aerosotherapy + Autogenic drainage

干预措施: Aerosoltherapy (Drug)

Asl

Active Comparator

Aerosoltherapy alone

干预措施: Aerosoltherapy (Drug)

结局指标

主要结局

Change in Lung Clearance Index

时间窗: Up to 2 weeks

LCI will be measured before, immediately after and 2h after the experimental or control conditions as well as before and after an hospitalization.

次要结局

  • Impedance variation(Up to 1 hour)

研究者

发起方
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
申办方类型
Other
责任方
Sponsor

研究点 (1)

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