跳至主要内容
临床试验/NCT03042065
NCT03042065Unknown不适用

Salbutamol in the Pediatric Emergencies: Nebulization Estimated Via AerogeN or Jet

Centre d'Investigation Clinique et Technologique 8050 个研究点目标入组 60 人开始时间: 2017年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
主要终点
The main analysis criteria is the Peak expiratory flow (PEF) value performed before the first aerosol of salbutamol aerosols using Jet or Aerogen spray.

研究概览

简要总结

Controlled trial of nebulized salbutamol using jet nebulizer or vibrating mesh technology in children presenting with acute moderate to severe asthma.

详细描述

Asthma is a chronic (long-term) lung disease that inflames and narrows the airways. Asthma causes recurring periods of wheezing (a whistling sound when you breathe), chest tightness, shortness of breath, and coughing. The coughing often occurs at night or early in the morning. Sometimes asthma symptoms are mild and go away on their own or after minimal treatment with asthma medicine. Other times, symptoms continue to get worse. When symptoms get more intense and/or more symptoms occur, it is called an asthma attack. Asthma attacks also are called flare-ups or exacerbation.

International Study of Asthma and Allergies in Childhood (ISAAC) found that about 14% of the world's children were likely to have had asthmatic symptoms in the last year and, crucially, the prevalence of childhood asthma varies widely between countries, and between centers within countries studied. These conclusions resulted from ISAAC's groundbreaking survey of a representative sample of 798,685 children aged 13-14 years in 233 centers in 97 countries. (ISAAC also studied a younger age group of children (6-7 years) and the findings were generally similar to the older children). These adolescents were asked whether they had experienced wheeze in the preceding 12 months. Prevalence of recent wheeze varied widely. The highest prevalence (>20%) was generally observed in Latin America and in English-speaking countries of Australasia, Europe and North America as well as South Africa. The lowest prevalence (<5%) was observed in the Indian subcontinent, Asia-Pacific, Eastern Mediterranean, and Northern and Eastern Europe. In Africa, 10-20% prevalence was mostly observed .

The majority of children with asthma have stable disease, and only a minority experience exacerbations needing hospitalization or emergency room visits. In older children, recent advances in treatment seem to have reduced chronic morbidity as well as the number of acute exacerbations. In infants and younger children, this goal may be more difficult to achieve, given the heterogeneity of obstructive lung disease in this age group. Viral wheeze is a very common clinical scenario in young children, and identification and proper treatment of subjects with potential for development of asthma and future exacerbations is still an unresolved challenge. Even if severe asthma exacerbations are relatively common, mortality from asthma in children is rare and declining. In the United Kingdom the mortality rate for children 0-14 years is less than one per 100.000 children per year. In contrast, there has been a vast increase in the economic costs associated with asthma. However, the main economic burden of childhood asthma is linked to indirect costs, long-term follow up and medication, and not to hospitalization .

Acute severe asthma represents one of the most common medical emergency situations and the most serious clinical presentation of asthma. Asthma is typically characterized by the presence of severe respiratory distress due to an asthma episode that requires the use of bronchodilators, oxygen and corticosteroids. Asthma attack can be severe and even life threatening. Features of acute severe attack include; Peak expiratory flow (PEF) 33-50% of best (use % predicted if recent best unknown), tachycardia and tachypnea. Life threatening attack includes pulse oxymetry <92%, Silent chest, cyanosis, or feeble respiratory effort, Arrhythmia or hypotension Exhaustion, altered consciousness. A severe asthma exacerbation can usually be presented clinically with dyspnea at rest; interferes with conversation and peak expiratory flow rate (PEFR) < 40%, usually requires hospitalization .

Acute severe asthma is one of the most common medical emergency situations in childhood, and physicians caring for acutely ill children are regularly faced with this condition. The cornerstones of the management of acute asthma in children are rapid administration of oxygen, inhalations with bronchodilators and systemic corticosteroids. Inhaled bronchodilators may include selective b2-agonists, adrenaline and anticholinergics. Additional treatment in selected cases may involve intravenous administration of theophylline, b2-agonists and magnesium sulphate. Both non-invasive and invasive ventilation may be options when medical treatment fails to prevent respiratory failure. It is important that relevant treatment algorithms exist, applicable to all levels of the treatment chain and reflecting local considerations and circumstances .

研究设计

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

入排标准

年龄范围
8 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 8-16 years.
  • Patient with severe asthma (maximum expiratory flow <50%).
  • Patient admitted to pediatric emergency.
  • Patient who has agreed to participate, as well as the parents or legal guardian.

排除标准

  • Chronic respiratory failure, infectious disease, heart disease.
  • Refusal to participate in the study.
  • No affiliation to a social security scheme (beneficiary or beneficiary).
  • Immediate intubation criteria

结局指标

主要结局

The main analysis criteria is the Peak expiratory flow (PEF) value performed before the first aerosol of salbutamol aerosols using Jet or Aerogen spray.

时间窗: 2 minutes

before the first nebulization

The main analysis criteria is the Peak expiratory flow (PEF) value performed after the first aerosol of salbutamol aerosols using Jet or Aerogen spray.

时间窗: 2 minutes

after the first nebulization

The main analysis criteria is the Peak expiratory flow (PEF) value performed after the second aerosol of salbutamol aerosols using Jet or Aerogen spray.

时间窗: 2 minutes

after the second nebulization

The main analysis criteria is the Peak expiratory flow (PEF) value performed after the third aerosol of salbutamol aerosols using Jet or Aerogen spray.

时间窗: 2 minutes

after the third nebulization

次要结局

未报告次要终点

研究者

发起方
Centre d'Investigation Clinique et Technologique 805
申办方类型
Other
责任方
Sponsor

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