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临床试验/NCT02600039
NCT02600039Unknown不适用

The Short-term Effect of ELTGOL on Pulmonary Ventilation Valued Through Electrical Impedance Tomography in Cystic Fibrosis Patients: Randomized Crossover Study

Universidade Federal de Pernambuco1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
10
试验地点
1
主要终点
Average Electrical Impedance on the End-Expiration

研究概览

简要总结

Cystic Fibrosis (CF) is the most common lethal autosomal recessive disease. Respiratory therapy is always recommended to the CF patient with pulmonary involvement and has differents techniques and devices, however, there is no consensus on the effectiveness of the techniques used, there is a need to determine the applicability of the therapeutic resources used. Therefore, the aim of the study is to determine the short-term effectiveness of ELTGOL on Average Electrical Impedance on the End of Expiration (MIEFE) pulmonary, assessed by Electrical Impedance Tomography (EIT) in individuals with CF through a clinical trial randomized crossover. Volunteers will be included with FC with moderate to severe lung disease with chest ≥ 74 cm that do not show: episode of pulmonary infectious exacerbations in the last four weeks or during the study period; cor pulmonale; facial deformity that causes air leakage; facial trauma and recent face or esophagus surgery; chest pain; hemoptysis in the last week; continued use of supplemental oxygen (> 8 hours / day); hemoptysis; hemodynamic instability and do not understand the use and command of the techniques used. The sample is selected by convenience from the database of individuals assisted data in Integrative Medicine Institute Professor Fernando Figueira (IMIP). The research will be developed in three phases, divided into three days with an interval of at least 48 hours between phases. The first day will undergo initial assessment and in the days following the intervention by day, ELTGOL or Acapella, in a randomized order.

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
Double (Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Volunteers with Cystic Fibrosis and lung disease with chest hemiperímetro ≥ 37 cm.

排除标准

  • Episode of pulmonary infectious exacerbations in the last four weeks or during the study period; cor pulmonale; facial deformity that causes air leakage; facial trauma and recent face or esophagus surgery; chest pain; hemoptysis in the last week; continued use of supplemental oxygen (> 8 hours / day); hemoptysis; hemodynamic instability and do not understand the use and command of the techniques used.

结局指标

主要结局

Average Electrical Impedance on the End-Expiration

时间窗: up to 30 minutes

次要结局

  • Preferred technique assessed by an open question(up to 3 minutes)
  • Dyspnea assessed by the Borg scale(baseline, one minute and thirtieth minutes)
  • Oxygen saturation assessed by oximeter(baseline, one minute and thirtieth minutes)
  • Adverse Effects associeted with ELTGOL and Acapella assessed by an open question(baseline, one minute and thirtieth minutes)

研究者

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

Amanda Silva Couto

Principal Investigator

Universidade Federal de Pernambuco

研究点 (1)

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