NCT01414322Unknown不适用
Documentation of Continuous Wheeze and Cough Dynamics in Pediatric ER SOB Patients
KarmelSonix Ltd.1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2011年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- increase or decrease of WheezeRate (the proportion of wheezing in the respiratory cycle)
研究概览
简要总结
Phenotype characterization of shortness of breath of pediatric emergency room patients by objective wheeze and cough monitoring improves diagnostic and severity assessment accuracy and correlates with overall patient outcomes.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient is admitted to the ER with shortness of breath
- •patient management is according to standardized protocols used in Hadassah Mt. Scopus pediatric emergency department including:
- •asthma management protocol
- •bronchiolitis management protocol
- •ages 0 - 15
- •patient's parent/guardian is able to comprehend and give informed consent for participating in the study
排除标准
- •patient has received any dose of inhaled bronchodilators in the hour prior to enrollment
- •patient has received oral or IV steroids in a time window of 30 minutes to 5 hours prior to enrollment
- •ventilated patients, while ventilated
- •chest skin lesions
- •cystic fibrosis
- •hemodynamic instability
- •patient's parent/guardian objects to the study protocol
- •concurrent participation in any other clinical study
- •physician objection
结局指标
主要结局
increase or decrease of WheezeRate (the proportion of wheezing in the respiratory cycle)
时间窗: Duration (from beginning to end) of emergency department stay. On average, 3 hours.
Characterize the dynamic pattern of wheeze rate (increase or decrease by 50% or unchanged) within 30 minutes of onset of therapy, and to correlate pattern to clinical diagnoses, severity assessment (accessory muscle use, oxygen saturation, inspiratory/expiratory ratio, severity of wheezing), and outcome (admission versus discharge).
次要结局
- cough count (increase or decrease by more then 1 cough event or unchanged) in response to treatment(Duration (from beginning to end) of emergency department stay. On average, 3 hours.)
研究者
研究点 (1)
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