Reducing Medication Errors and Time to Vasoactive Drugs Preparation and Delivery During Pediatric Cardiopulmonary Resuscitation: a Multicenter, Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 6
- 主要终点
- Medication dosage errors
研究概览
简要总结
The investigators recruit nurses working in 5 swiss Pediatric Emergency Departments or divisions to prepare continuous infusions of vasoactive drugs during a simulation-based pediatric CPR cardiac arrest scenario. According to randomization, nurses will have to prepare and deliver vasoactive drugs following their current conventional methods or by the aim of a mobile tablet application called PedAMINES™. PedAMINES™ is designed to support them step-by-step from order to delivery of these drugs.
- Primary outcome will be to measure in each allocation group the number of medication dosage errors committed during each drug preparation sequence until injection.
- Secondary outcome will be to measure the time to drug preparation (TDP) and time to drug delivery (TDD).
详细描述
During pediatric cardiopulmonary resuscitation (CPR), vasoactive drug preparation for continuous infusion is both complex and time-consuming, placing children at higher risk than adults for medication errors. It is well established that CPR duration is inversely correlated to survival, decreasing linearly by 2.1 % per minute, and to decreased risk of neurological sequelae [1].
In this study, the investigators recruit nurses working in 5 swiss Pediatric Emergency Departments or divisions to prepare continuous infusions of vasoactive drugs during a simulation-based pediatric CPR cardiac arrest scenario with a high-fidelity manikin (Laerdal SimJunior™). The scenario will take place in the shock room to increase realism.
According to randomization with a 1:1 allocation ratio, nurses will have to prepare and deliver vasoactive drugs following their current conventional methods or by the aim of a mobile tablet application called PedAMINES™ (Pediatric Accurate Medication In Emergency Situations). PedAMINES™ is designed to support nurses step-by-step from order to delivery of a wide range of drugs, especially those requiring continuous infusion. PedAMINES™ has already been shown in a single-center simulation-based study to reduce time to vasoactive drug preparation, to delivery and the rate of medication errors [2].
On the day of participation, after obtaining nurse's written informed consent and randomization, nurses will receive a standardized 5-minute training session on how to use the app. Then, the nurses will be asked to perform a standardized 15-minute highly realistic CPR scenario, including post-return of spontaneous circulation (ROSC). After epinephrine-induced ROSC, nurses will be asked to first prepare a continuous infusion of dopamine, using either PedAMINES™ or a conventional method, and then a continuous infusion of norepinephrine by crossing the procedure. Moreover, 2 questionnaires will be given before and after the scenario to ask the nurses about their demographics data, perceived stress and degree of satisfaction.
- Primary outcome will be to measure in each allocation group the number of medication dosage errors committed during each drug preparation sequence until injection.
- Secondary outcome will be to measure the time to drug preparation (TDP) and time to drug delivery (TDD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Blinding to the purpose of the study during recruitment will be maintained to minimize preparation bias. Nurses will be "unblinded" when the simulated scenario start.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To be nurse certified
- •To know how to prepare intravenous drugs injection.
- •To have previously completed the 5-minute introductory course to the use of PedAMINES dispensed by the investigators of the study.
- •Participation agreement
排除标准
- •To have at any time undergone a previous experiment with a cognitive numeric device aimed to help vasoactive drugs preparation.
- •To have not undergone the 5-minute introductory course to the use of PedAMINES.
研究组 & 干预措施
Arm A (PedAMINES™ / Conventional Method)
A 2-period study where nurses will be randomized to a 15-minute CPR scenario to prepare and deliver Dopamine with the help of PedAMINES™ first, then crossover (incl. washout period) to prepare and deliver Norepinephrine with the help of a Conventional Method.
干预措施: PedAMINES™ / Conventional Method (Device)
Arm B (Conventional Method / PedAMINES™)
A 2-period study where nurses will be randomized to a 15-minute CPR scenario to prepare and deliver Dopamine with the help of a Conventional Method first, then crossover (incl. washout period) to prepare and deliver Norepinephrine with the help of PedAMINES™.
干预措施: Conventional Method / PedAMINES™ (Device)
结局指标
主要结局
Medication dosage errors
时间窗: On the day of study participation
To measure in each allocation group the number of medication dosage errors committed during each drug preparation sequence until injection.
次要结局
- Time to drug preparation (TDP) and time to drug delivery (TDD)(On the day of study participation)
研究者
Johan Siebert
MD: Emergency Physician
University Hospital, Geneva