跳至主要内容
临床试验/NCT03136042
NCT03136042已完成不适用

A Randomized Crossover Study of Sputum Induction by Physiotherapy and Hypertonic Saline Techniques in Asthmatic Children.

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2016年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
2
主要终点
Sputum induction by physiotherapists maneuvers

研究概览

简要总结

This study evaluated whether physiotherapy is efficient in sputum induction and in evaluation of pulmonary inflammation in asthmatic children.

详细描述

The hypertonic saline is a traditional technique to collect induced sputum, it´s safe and viable in asthmatic children, as well as the technique of sputum induction and processing has been standardized for schoolchildren.

Sometimes researchers have difficulties to obtain induced sputum in stable patients and it´s possible to use physiotherapy maneuvers to induced sputum. The manouvers are safe for adult and children asthmatics stable.

This study aimed to evaluate the effectiveness to collect induced sputum by physiotherapy maneuvers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
7 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Asthmathic children used inhaled corticosteroids not associated with long-acting beta2-agonist.

排除标准

  • Asthmathic children to diagnose with other chronic pulmonary pathologies (cystic fibrosis, ciliary dyskinesia, bronchiolitis obliterans, and bronchopulmonary dysplasia) before study, no significant pulmonary pathologies, incapacity to realize pulmonary function and insufficient sample.

研究组 & 干预措施

physiotherapists maneuvers

Experimental

physiotherapy techniques

干预措施: physiotherapy techniques (Other)

hypertonic saline 3%

Active Comparator

four nebulizations with 3% hypertonic saline.

干预措施: hypertonic saline 3% (Other)

saline + physiotherapy maneuvers

Active Comparator

1 nebulizations + physiotherapy techniques

干预措施: saline + physiotherapy maneuvers (Other)

结局指标

主要结局

Sputum induction by physiotherapists maneuvers

时间窗: 3 days

children were seated in a position where the thorax was inclined forwards by 45°, they were instructed to perform calm and long exhalations by oscillating positive expiratory pressure (OPEP) during nonstop 5 minutes holding a Flutter® (Scandipharm, Birmingham, AL, EUA). After that, children were positioned in supine zero degree and underwent for more five minutes to a forced exhalation with the open mouth/glottis (huffing) associated to acceleration by forced expiratory technique (FET), performed by the therapist by positioning a hand on xiphoid process and the other in the manubrium sternum.

次要结局

  • Sputum induction by hypertonic saline 3%(3 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Beatriz Mangueira Saraiva Romanholo

PhD

University of Sao Paulo

研究点 (2)

Loading locations...

相似试验