The Effect of Mouth Breathing on Exercise Induced Bronchoconstriction in Children.
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Primary end point
研究概览
简要总结
Introduction: Exercise induced bronchoconstriction (EIB) is a common finding in the pediatric population with and without asthma. EIB is suspected with a drop of 10-15% in Forced expiratory volume in the 1st second (FEV1) during exercise challenge test (ECT). Some researchers assume that oral breathing, in several mechanisms, increase hyper-responsiveness of the airways.
Aim: Asses the effect of a nose clip and allergic rhinitis in EIB. Hypothesis: The use of a nose clip in exercise challenges will increase the rate of positive tests. However, we assume that children with symptomatic allergic rhinitis will not demonstrate similar trends.
Methods: A prospective, single center cohort study in a pediatric pulmonology institute, at Ruth's children hospital, Rambam medical center, Haifa, Israel. Children referred for ECT will be registered to the study and will be evaluated in two separate visits. Visit 1 - ECT with a nose clip and visit 2 - ECT without a nose clip. Demographic and clinical data and measurements of serial vital signs, exercise data and lung functions will be taken, as well as Total Nasal Symptoms Score (TNSS) and Asthma Control Test (ACT) questionnaires.
详细描述
Introduction
Exercise induced bronchoconstriction (EIB) is a common finding in the pediatric population with and without asthma. EIB is evaluated with serial measurements of lung functions during exercise protocol. EIB is suspected with a drop of 10-15% in Forced expiratory volume in the 1st second (FEV1) during exercise challenge test (ECT). Some researchers assume that oral breathing, in several mechanisms, increase hyper-responsiveness of the airways.
Aim: Asses the effect of a nose clip and allergic rhinitis in exercise induced bronchoconstriction.
Hypothesis
The use of a nose clip in exercise challenges will increase the rate of positive tests. However, we assume that children with symptomatic allergic rhinitis will not demonstrate similar trends.
Methods: A prospective, single center cohort study in a pediatric pulmonology institute, at Ruth's children hospital, Rambam medical center, Haifa, Israel, during 2020-2021. Children referred for ECT will be registered to the study after signing an informed consent and will be evaluated in two separate visits. Visit 1 - ECT with a nose clip and visit 2 - ECT without a nose clip. ECT will be conducted according to the institute protocol, based on American Thoracic Society (ATS) guidelines. Demographic and clinical data and measurements of serial vital signs, exercise data and lung functions will be taken, as well as Total Nasal Symptoms Score (TNSS) and Asthma Control Test (ACT) questionnaires.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Exercise challenge test as part of exercise induced asthma evaluation.
- •Age 6-18 years.
排除标准
- •Other chronic lung disease
- •Significant background illness
- •Severe asthma exacerbation or systemic steroids - last 2 months
- •Persistent use of inhaled steroids - last 2 weeks
- •Use of short acting bronchodilators - last 24 hours.
结局指标
主要结局
Primary end point
时间窗: 15 minutes
Maximum drop of forced expiratory volume in one second - (FEV1) after exercise challenge test with and without Nose clip.
次要结局
- Secondary end point(15 minutes)