跳至主要内容
临床试验/CTRI/2020/03/024170
CTRI/2020/03/024170尚未招募不适用

Comparison Of Efficacy Of Nebulised Levosalbutamol Vs Levosalbutamol Metered Dose Inhaler-Spacer: A Single Centre Open Label Randomized Controlled Trial In Hospitalized Children With Wheezing

Jaipur Golden Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2020年3月23日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
70
试验地点
1
主要终点
improvement in the pulmonary score.

研究概览

简要总结

Inhospital, nebuliser and MDI-spacer aretwo mainstay aerosol drug delivery method for β 2 agonists administration, but due to the lack of awarenessand lack of understanding of the inhalational technique MDI –spacer is notcommonly employed in the acute management. However,in clinical routine and under the supervision of trained pro­fessionals, theMDI-spacer technique may be just as effec­tive as nebulisation. Although the efficacy of nebulization is broadly acknowledged, the method hasseveral disadvan­tages. Studies show that nebulization may be ineffective indelivering aerosolized medicine compared to the combina­tion MDI-spacer.Incase of acute wheezing current guidelines recommend the use of short-actingbronchodilators (β 2 agonists) inhalation to reverse airflow obstruction andtreat patients. Thatbeing said, the purpose of this study is to comparethe efficacy of levosalbutamol aerosol therapy given via MDI-spacer to that givenvia nebulizer in hospitalised children with wheezing by using pulmonary score.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Open Label

入排标准

年龄范围
1.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • 1.Children aged 1-12 year with acute wheezing and who will be admitted to Department of Pediatrics, Jaipur Golden Hospital.
  • 2.Pulmonary score : 4-9( MODERATE TO SEVERE).

排除标准

  • Chronic lung disease -Cyanotic congenital heart disease -Suspected foreign body aspiration -Life threatening signs (altered sensorium, bradycardia, poor pulse volume, cyanosis, silent chest).

结局指标

主要结局

improvement in the pulmonary score.

时间窗: Improvement in the pulmonary score at 0 minute, 30 minute, 60 minute, 3 hour, 6 hour, 12 hour, 24hour.

次要结局

  • Length of hospital stay.(Example. 24 hours)

研究者

申办方类型
Private hospital/clinic

研究点 (1)

Loading locations...

相似试验