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临床试验/CTRI/2018/01/011283
CTRI/2018/01/011283尚未招募不适用

Comparison of effectiveness of Metered dose inhaler with spacer and Nebulizer in children aged 5-14 years with acute asthma: Randomized Controlled Trial

Pt BDSharma PGIMS1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2018年5月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
Need for hospital admission

研究概览

简要总结

An informed written consent from parents will betaken. A randomizedcontrolled trial study design will be used. Subjects will be defined asasthmatic children aged 5-14 years who present to paediatric emergency withacute attack of asthma. With the help of computer generated randomization tablethe subjects will be divided into two groups. A sample size of 75 ineach group is taken. Enrolment number will be given toensure identity. Demographic data will be collected including name, father’sname, age, sex and address with phone number. Disease history will include theduration, severity of symptoms based on frequency of day and night symptoms,co-morbidities, family history and current treatment being received.Subjects in group 1 will receive Salbutamol with the helpof MDI and spacer (250ml) thrice at intervals of 20 minutes and subjects ingroup 2 will receive Salbutamol by oxygen driven nebulizer thrice at 20 minutesinterval. The subjects will be repeatedlyassessed to ensure clinical improvement. However, examination to record theparameters that will be used for the comparison of effectiveness by these twodevices will be conducted only four times during the observation period i.e.

  • ·        Before giving any therapy
  • ·        At 20 minutes duration
  • ·        At 40 minutes duration
  • ·        At 60 minutes duration.

The following parameters will be used for comparisonby using suitable statistical tests-

  • 1.      Respiratoryrate
  • 2.      Heartrate
  • 3.      Useof accessory muscles
  • 4.      Auscultatoryfindings
  • 5.      Peakexpiratory flow rate
  • 6.      Developmentof tremor
  • 7.      PaCO2on Venous Blood Gas Analysis
  • 8.      Needfor hospital admission
  • 9.      Durationof stay in emergency department

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
5.00 Year(s) 至 14.00 Year(s)(—)
性别
All

入选标准

  • Children aged 5-14 years diagnosed with acute asthma.

排除标准

  • Non consenting child.

结局指标

主要结局

Need for hospital admission

时间窗: Need for hospital admission | Duration of stay in the emergency department

Duration of stay in the emergency department

时间窗: Need for hospital admission | Duration of stay in the emergency department

次要结局

  • Respiratory Rate(Heart rate)

研究者

发起方
Pt BDSharma PGIMS
申办方类型
Government medical college

研究点 (1)

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