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临床试验/NCT03312452
NCT03312452已完成不适用

The Role of Infusion Pumps in Preventing the Over-Administration of Intravenous Fluid in Pediatric Dental Surgeries

University of Saskatchewan2 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2018年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
103
试验地点
2
主要终点
Average absolute difference between volume prescribed and infused

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participants will blinded to group allocation by concealment of the IV fluid delivery device in the operating room. Analysts will be presented with data that has been coded to conceal each participants' allocation to either the intervention or control group.

入排标准

年龄范围
2 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ASA 1 and 2 children presenting for dental surgery

排除标准

  • Children with pre-existing cardiac, renal, pulmonary or endocrine disease. In addition any child with an ASA score of 3 or greater.

研究组 & 干预措施

Infusion pump group

Experimental

Study subjects assigned to this group will receive intravenous fluid via an infusion pump (Hospira plum pump) during their surgery.

干预措施: Hospira plum pump (Device)

Gravity drip group

Active Comparator

Study subjects assigned to this group will receive intravenous fluid via a gravity drip device during their surgery.

干预措施: Gravity drip device (Device)

结局指标

主要结局

Average absolute difference between volume prescribed and infused

时间窗: From initiation of intravenous until arrival in the recovery room, up to three hours

Difference in volume originally prescribed and ultimately administered

次要结局

  • Volume of intravenous fluid administered(From initiation of intravenous until arrival in the recovery room, up to three hours)
  • Average percent difference between volume prescribed and infused(From initiation of intravenous until arrival in the recovery room, up to three hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jonathan Gamble

Assistant Professor

University of Saskatchewan

研究点 (2)

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