Comparison of the Bulb Aspirator to a Nasal Oral Aspirator in the Treatment of Bronchiolitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 236
- 试验地点
- 2
- 主要终点
- Unscheduled bronchiolitis return visits
研究概览
简要总结
The investigators aim to compare the standard bulb aspirator with that of a nasal oral aspirator. The hypothesis is that use of a nasal oral aspirator is more effective at removing nasal secretions in the treatment of bronchiolitis as measured by a predicted 50% decrease in the rate of unscheduled bronchiolitis return visits. The primary endpoint will be the number of unscheduled bronchiolitis return visits; secondary endpoints will include measurements of oral intake, respiratory relief, parental device preference and adverse events.
详细描述
This study will be a single center, single blind, randomized controlled trial in the pediatric emergency department (ED) at Dell Children's Medical Center of Central Texas (DCMC). An ED discharge diagnosis of bronchiolitis will trigger patients to be randomized to receive a bulb aspirator or nasal oral aspirator for home secretion management use. Prior to dispensing the randomized aspirator, a pre-distribution questionnaire will be administered. Additionally, patients will receive a diary to complete for 3 days post ED discharge. Research personnel will call families on day 4 as a reminder to return the diary and again on day 14 to obtain a verbal post-study questionnaire. Research personnel will perform chart review on all patients looking for unscheduled patient return visits for bronchiolitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 1 Month 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children >28 days of life to < 2 years of age discharged home from the DCMC ED with a diagnosis of bronchiolitis (diagnosis made per provider discretion)
- •Caregiver fluent in English or Spanish
排除标准
- •Previous enrollment
- •Hospital admission
- •Parental refusal to be randomized to an aspirator device (i.e., family prefers current device and does not wish to be randomized to a potentially different product)
- •Current bacterial pneumonia
- •Diagnosis of asthma
- •Chronic lung disease
- •Significant underlying cardiac disease
- •Chronic neuromuscular disease
研究组 & 干预措施
Bulb Aspirator
If randomized to the bulb aspirator group, the patient will be sent home with a bulb aspirator to use for home nasal secretion management
Nasal Oral Aspirator (NeilMed Naspira)
If randomized to the nasal oral aspirator group, patient will be sent home with a nasal oral aspirator to use for home nasal secretion management
干预措施: NeilMed Naspira (Device)
结局指标
主要结局
Unscheduled bronchiolitis return visits
时间窗: 14 days
The number of unscheduled bronchiolitis return visits (return to either ED, urgent care or PCP)
次要结局
- Oral intake(14 days)
- Respiratory relief(14 days)
- Parental device preference(14 days)
- Adverse events(14 days)
研究者
Whitney Schwarz
Principle Investigator
University of Texas at Austin