Assessing Response to Albuterol in Bronchiolitis
2017年1月31日 更新者：Christopher Carroll, MD、Connecticut Children's Medical Center
Bronchiolitis is a significant cause of morbidity and hospitalizations in children, accounting for more than 125,000 hospitalized children per year in the United States.
Although treatment is largely supportive, bronchodilator medications such as albuterol are frequently used due to increased pulmonary resistance in this population.2-4
However, despite four decades of clinical trials, the efficacy of albuterol in the treatment of bronchiolitis has yet to be proven.
This inconsistency is due in part to the lack of sufficiently sensitive methods for the evaluation of lung function and thus the response to albuterol in infants.
Because of the difficulties in evaluating the response to therapy, healthcare providers are forced to rely on their physical examination skills or a clinical scoring system, both of which are highly subjective in this population.
The investigators propose to conduct a prospective observational study of healthcare providers to determine the accuracy of clinical assessment as compared to that of pulmonary mechanics in a population of children intubated and mechanically ventilated for bronchiolitis.
研究概览
地位
完全的
条件
详细说明
We propose to conduct a prospective observational study of healthcare providers to determine the accuracy of clinical assessment as compared to the assessment of pulmonary mechanics in a population of children intubated and mechanically ventilated for bronchiolitis.
Before and at 20 minutes following a routinely scheduled albuterol treatment, measurements of pulmonary mechanics obtained as part of the child's clinical care will be compared to a healthcare provider's simultaneous clinical assessment.
Three healthcare providers (a nurse, physician, and respiratory therapist) will assess the child during these time periods.
Data regarding their observations will be recorded using a data collection tool (attached).
Healthcare providers will be blinded to each other's assessments and to the measurements of pulmonary mechanics.
Using sensitivity and specificity analysis, the healthcare provider's assessment of response will be compared to the standard assessment of response according to the measurements of pulmonary mechanics.
A precision of the estimate of sensitivity and specificity will be calculated.
Clinical characteristics of the child will be recorded.
Each child may be assessed on up to three occasions if that child receives greater than 1 dose of albuterol.
However, no more than 3 providers will assess the child at one time.
研究类型
观察性的
注册 (实际的)
29
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Connecticut
-
Hartford、Connecticut、美国、06106
- Connecticut Children's Medical Center
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
不超过 2年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Children hospitalized in the intensive care unit with bronchiolitis
描述
Inclusion Criteria:
- Hospitalization with a primary admission diagnosis of bronchiolitis
- Age between birth and 2 years
- Intubated with < 1 cm H2O leak around endotracheal tube
- Receiving inhaled albuterol therapy
Exclusion Criteria:
- Not meeting inclusion criteria
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Our primary outcome is the response to albuterol.
大体时间：20 minutes following an albuterol treatment
|
20 minutes following an albuterol treatment
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Christopher L Carroll, MD, MS、Connecticut Children's Medical Center
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年11月1日
初级完成 (实际的)
2016年11月1日
研究完成 (实际的)
2016年11月1日
研究注册日期
首次提交
2010年11月8日
首先提交符合 QC 标准的
2010年11月9日
首次发布 (估计)
2010年11月10日
研究记录更新
最后更新发布 (估计)
2017年2月2日
上次提交的符合 QC 标准的更新
2017年1月31日
最后验证
2017年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.