A randomized controlled open label trial (RCT) of vibration mesh technology (Aeroneb) vs conventional jet nebulization in children with moderate to severe Acute Asthma.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- In patients with acute moderate to severe asthma we will assess improvement in CAS Score less than or equal to 2 with clinical improvement(No respiratory distress, improved oral intake, able to comprehend)
研究概览
简要总结
| Asthma is a common and potentially serious chronic disease that imposes a substantial burden on patients, their families, and community. Asthma is a common disease amongst children in India with prevalence estimated at 5-10%. A worldwide increase in the prevalence of asthma is being reported with increase in wheeze at an alarming rate of 5% per year. |
Globally, about 30–35% of children suffer from allergic disorders, and the prevalence of these illnesses has been rising in recent years. Atopic dermatitis, allergic rhinitis, asthma, and food allergies are some of the childhood allergic disorders, of which asthma is the most common chronic condition among children and adults.[1]
Bronchial asthma is a chronic inflammatory disorder in which several cells and cellular elements are involved. In susceptible individuals this inflammation causes recurrent episodes of wheezing, breathlessness, chest tightness and cough, particularly at night and early morning. These episodes are associated with variable and widespread airway obstruction that is often reversible either spontaneously or with treatment. The inflammation also causes increase in bronchial hyper-’ responsiveness to a variety of stimuli.
Asthma can severely limit the ability to engage in normal daily activities, including sports and outdoor activities, poor sleep, fatigue, and permanent decline in lung function.[2] It accounts for more than 10 million missed school days each year and is the third principal cause of child hospitalization.[3]
The main treatment of an acute exacerbation includes inhaled short-acting β2-agonists (SABA) and inhaled anticholinergic like ipratropium bromide and inhaled corticosteroids in moderate to severe cases. Nebulizers are commonly used in emergency departments to deliver bronchodilators to children with asthma exacerbations.
However, no clinical study comparing a vibrating mesh nebulizer with a jet nebulizer is available in this paediatric population. The vibration mesh technology-based nebulisation may be more effective as drug deposition is 6-8 times more than jet and ultrasonic nebulisation in the patients small airways.
The aim of this of study was to compare the clinical efficacy of a jet nebulizer and aerogen using vibration mesh technology for delivering SABA in children aged 2-18 years presenting to the emergency department with moderate to severe acute asthma
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 2.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Any child aged 2- 18 years with moderate to severe acute asthma, i.e. CASS score ≥ 4.
排除标准
- •1 Any child with acute asthma who already received nebulization in present episode of exacerbation.
- •2 cardiovascular disease 3 cystic fibrosis 4 chronic lung disease 5 airway anomalies •immunodeficiency syndromes •coexisting medical conditions such as pneumonia, or if they were in impending respiratory failure.
- •â€¢Patients who already received bronchodilator treatment within 24 hrs of the emergency department presentation.
结局指标
主要结局
In patients with acute moderate to severe asthma we will assess improvement in CAS Score less than or equal to 2 with clinical improvement(No respiratory distress, improved oral intake, able to comprehend)
时间窗: For first 6 hrs we will assess improvement in CAS score less than or equal to 2 with clinical improvement, followed by assessment every 2-4hrs.
次要结局
- • To study the duration of admission rate and hospital stay in both the groups(• To study the difference in dosage requirement of SABA after initial first hour nebulization in both groups)
研究者
Nikhita V N
INHS ASVINI