The Incidence of IV Fluid Over-administration in Pediatric Dental Surgeries When Infusion Pumps Are Employed
2018年10月30日 更新者:Jonathan Gamble、University of Saskatchewan
The Role of Infusion Pumps in Preventing the Over-Administration of Intravenous Fluid in Pediatric Dental Surgeries
A prospective, analyst-blinded, randomized control trial to assess the incidence of intravenous (IV) fluid over-administration in the setting of pediatric dental surgeries.
Anesthetists will be randomized to either administer their IV fluid through an infusion pump or a gravity drip device.
研究概览
详细说明
In the perioperative setting, IV fluids are administered to mitigate the effects of preoperative fasting and sources of fluid loss that are unique to surgical intervention.
Significant harms have been associated with the over-administration of IV fluid in pediatric patients.
Infusion pumps have been shown to reduce medication administration errors in inpatients receiving continuous IV infusions.
In contrast, laboratory experiments have demonstrated that gravity driven fluid delivery systems are influenced by numerous extrinsic factors.
To date, no work has investigated the perioperative incidence of IV fluid over-administration in pediatric patients randomized either to infusion pumps (intervention) or gravity-fed IV systems (control).
研究类型
介入性
注册 (实际的)
103
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
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Saskatchewan
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Saskatoon、Saskatchewan、加拿大、S7M5M9
- University of Saskatchewan
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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
2年 至 12年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- ASA 1 and 2 children presenting for dental surgery
Exclusion Criteria:
- Children with pre-existing cardiac, renal, pulmonary or endocrine disease. In addition any child with an ASA score of 3 or greater.
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:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Infusion pump group
Study subjects assigned to this group will receive intravenous fluid via an infusion pump (Hospira plum pump) during their surgery.
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The Hospira plum pump enables the clinician to program a specific volume of intravenous fluid and define a period of time over which to administer this fluid.
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有源比较器:Gravity drip group
Study subjects assigned to this group will receive intravenous fluid via a gravity drip device during their surgery.
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Study subjects assigned to this group will receive intravenous fluid via a gravity drip device during their surgery.
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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 |
|---|---|---|
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Average absolute difference between volume prescribed and infused
大体时间:From initiation of intravenous until arrival in the recovery room, up to three hours
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Difference in volume originally prescribed and ultimately administered
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From initiation of intravenous until arrival in the recovery room, up to three hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Volume of intravenous fluid administered
大体时间:From initiation of intravenous until arrival in the recovery room, up to three hours
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Volume of fluid received over surgical course (mL/kg/hr)
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From initiation of intravenous until arrival in the recovery room, up to three hours
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Average percent difference between volume prescribed and infused
大体时间:From initiation of intravenous until arrival in the recovery room, up to three hours
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Percent difference in volume originally prescribed and ultimately administered
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From initiation of intravenous until arrival in the recovery room, up to three hours
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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:Duncan EJ Bowes, M.D.、Resident principal investigator
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 (实际的)
2018年9月1日
初级完成 (实际的)
2018年10月19日
研究完成 (实际的)
2018年10月19日
研究注册日期
首次提交
2017年10月12日
首先提交符合 QC 标准的
2017年10月16日
首次发布 (实际的)
2017年10月17日
研究记录更新
最后更新发布 (实际的)
2018年10月31日
上次提交的符合 QC 标准的更新
2018年10月30日
最后验证
2018年10月1日
更多信息
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