Clinical Trial of a Computer-driven Weaning System for Patients Requiring Mechanical Ventilation
2017年11月9日 更新者:Boston Medical Center
A Randomized Controlled Trial of Computer-Driven Weaning Compared With Standard of Care Weaning in Medical Patients Requiring Mechanical Ventilation
The purpose of this study is to compare the efficacy of a computer-assisted ventilator weaning system (Drager Smartcare) to our current standard of care in the medical intensive care unit.
研究概览
研究类型
介入性
注册 (实际的)
33
阶段
- 不适用
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
-
-
Massachusetts
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Boston、Massachusetts、美国、02118
- Boston Medical Center
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-
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
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age greater than 18 years
- Initiated on mechanical ventilation via endotracheal tube
- Admitted to Medical Intensive Care Unit and Medical Intensive Care Unit Team (Harrison Avenue Campus, Menino Pavilion)
- Requiring mechanical ventilation for more than 48 hours
- Meets prespecified weaning criteria
Exclusion Criteria:
- Do Not Resuscitate/Do Not Intubate order
- Pregnancy
- Mechanical ventilation initiated at another hospital
- Cardiac arrest for more than 5 minutes with poor neurologic prognosis
- Tracheostomy
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
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Computer-assisted weaning
Group assigned to the computer-assisted weaning program
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Closed-loop, knowledge-based, computer-assisted wean program initiated at the start of ventilator weaning.
其他名称:
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有源比较器:Standard of care weaning
Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.
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Evidence-based standard of care weaning process.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Duration of Weaning
大体时间:Continuous (median weaning duration was 2 days)
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Duration of weaning was assessed as the time from the initiation of weaning (randomization) to the time of successful extubation (defined as 48 hours free of mechanical ventilation).
Patients were followed for the duration of hospitalization and the time of weaning onset and successful liberation from the ventilator was noted.
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Continuous (median weaning duration was 2 days)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Duration of ICU Stay
大体时间:from start of weaning to discharge from ICU, on average 1-2 weeks
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Duration of ICU stay after weaning initiation
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from start of weaning to discharge from ICU, on average 1-2 weeks
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Duration of Mechanical Ventilation
大体时间:from start of weaning to liberation from ventilator, on average 1-2 days
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Duration of mechanical ventilation from weaning initiation
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from start of weaning to liberation from ventilator, on average 1-2 days
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Duration of Hospitalization
大体时间:from start of weaning to discharge from hospital, on average 1-2 weeks
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from start of weaning to discharge from hospital, on average 1-2 weeks
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Inpatient Mortality
大体时间:28 days
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proportion of patients in each arm who died in the hospital
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28 days
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Sedation Requirements
大体时间:during weaning, on average 1-2 days
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measure was not recorded
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during weaning, on average 1-2 days
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Number of Spontaneous Breathing Trials Prior to Extubation
大体时间:from start of weaning to liberation from ventilator, on average 1-2 days
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from start of weaning to liberation from ventilator, on average 1-2 days
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Complications (Death During Wean, Ventilator-associated Pneumonia During Wean, Self Extubation, Re-intubation)
大体时间:Duration of weaning (median 2 days)
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This outcome is a composite outcome of the total number of participants with any one of the above-listed weaning-associated complications.
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Duration of weaning (median 2 days)
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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:Christine C Reardon, MD、Boston University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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
2008年1月1日
初级完成 (实际的)
2010年5月1日
研究完成 (实际的)
2010年5月1日
研究注册日期
首次提交
2008年1月3日
首先提交符合 QC 标准的
2008年1月22日
首次发布 (估计)
2008年2月4日
研究记录更新
最后更新发布 (实际的)
2017年12月11日
上次提交的符合 QC 标准的更新
2017年11月9日
最后验证
2017年11月1日
更多信息
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