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临床试验/NCT03074682
NCT03074682已完成不适用

Fluid Administration With LifeFlow vs Push/Pull

Yale University1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2017年2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
54
试验地点
1
主要终点
Successful Administration of 60 mL/kg

研究概览

简要总结

The aim of the study is to determine if a new device is more effective in fluid administration than devices currently used when resuscitating pediatric patients in septic shock. This study will take place in a simulation lab setting and will not include the use of patients.

详细描述

In this study, participants will be randomized to one of three devices in a Pediatric Intensive Care Unit simulation setting. Each participant will be provided the device, a 1L NS bag, tubing and a 22g IV. In each scenario, the objective will be to administer 3 20cc/kg boluses within a 15 minute period to the simulated patient.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •Pediatric emergency medicine or pediatric intensive care unit nurses, pediatric residents, medics and attendings.

排除标准

  • •Inability to operate equipment due to illness or physical impairment.

研究组 & 干预措施

Lifeflow

Experimental

Participants in this arm will use the Lifeflow device to administer fluid in a simulation in a simulation setting.

干预措施: Lifeflow (Device)

Push/Pull

Active Comparator

Participants in this arm will use the Push/Pull method to administer fluid in a simulation in a simulation setting.

干预措施: Push/Pull (Device)

Pressure Bag

Active Comparator

Participants in this arm will use a Pressure Bag to administer fluid in a simulation in a simulation setting.

干预措施: Pressure Bag (Device)

结局指标

主要结局

Successful Administration of 60 mL/kg

时间窗: 20 minutes

Participants will be timed to determine if they are able to administer 60 mL/kg of fluid within a 20 minute timeframe. This outcome will be measured as a dichotomous 'yes' or 'no' as to whether the task was completed successfully. The initial registered primary outcome was changed from 60 cc/kg in 15 minutes to its current format before the study began.

次要结局

  • Time to Complete Fluid Administration(Up to 20 minutes)
  • NASA Task Load Index (TLX)(15 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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