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临床试验/NCT00922350
NCT00922350已完成不适用

Heliox and Posture Optimize Action of Nebulization With Bronchodilators for Asthma Attacks. Randomized Trial.

Universidade Federal de Pernambuco1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2008年6月1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
59
试验地点
1
主要终点
Spirometry

研究概览

简要总结

The purpose of this study is to verify that nebulization with bronchodilators associated with heliox gas (helium + oxygen) and the posture of a leaning forward truck is effective in patients with an asthma attack.

详细描述

When associated with inhaled bronchodilators, the heliox, a mixture of helium and oxygen in obstructive lung diseases with asthma, reduces the turbulence of airflow despite high rates, due to its low density.

Although the first report of the use of heliox in the treatment of asthma dating to 1935, few controlled studies are available clarify the impact of the use of heliox in hospital admission of patients with acute asthma attacks refractory to standard treatment.

The severe airflow obstruction, observed in cases of acute asthma, also leads to lung hyperinflation that favors the increase of respiratory work by increasing the load for the inspiratory muscles by placing them at a mechanical disadvantage.

Various body positions were studied relating them to muscle activity with mechanical disadvantage. These studies suggest that the influence posture acts mainly in the position of the diaphragm, thus, increasing the stress related to other muscles such as the abdominals and the effect of gravity on these.

This study aims to: assess the efficiency of the positioning body associated with nebulization with bronchodilators carried by heliox during acute severe asthma in adults, using as the primary outcomes FEV1, FVC and PEF and secondary outcomes as the Borg scale, inspiratory capacity, RR, HR and SpO2.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •reversibility of bronchial obstruction after administration of bronchodilator drugs for at least 10% in FEV1
  • •a clinical diagnosis of acute severe asthma
  • •a history of asthma over 1 year
  • •duration of the crisis of current asthma lasting less than seven days

排除标准

  • •were unable to understand or perform the spirometric maneuver
  • •smoking (within the last 3 years associated with a higher consumption of 100 cigarettes/year)
  • •other pulmonary comorbidities
  • •lower to upper airways
  • •heart failure
  • •heart rate greater than 150 bpm
  • •systolic pressure below 90 mmHg or greater than 150 MHG
  • •pregnancy
  • •inability to stay inline with the trunk forward

研究组 & 干预措施

heliox+posture

Experimental

The patients in this group carried out the mist carried by heliox and the trunk tilted forward

干预措施: HELIOX+POSTURE (Other)

oxygen+posture

Experimental

The patients in this group carried out the mist carried by oxygen and the trunk tilted forward

干预措施: OXYGEN + POSTURE (Other)

oxygen

Active Comparator

The patients in this group carried out the mist carried by the oxygen and the trunk upright

干预措施: OXYGEN (Other)

heliox

Experimental

The patients in this group underwent nebulization with heliox carried by the trunk erect

干预措施: HELIOX (Other)

结局指标

主要结局

Spirometry

时间窗: 6 months

次要结局

  • Respiratory rate(6 months)
  • Peripheral oxygen saturation(6 months)
  • Borg scale(6 months)
  • Heart rate(6 months)

研究者

申办方类型
Other

研究点 (1)

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