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临床试验/NCT06804915
NCT06804915已完成不适用

A Mobile App for Drug Dosage Calculation in the Context of Pediatric and Adult Resuscitation: a Cross-Over Randomized Controlled Trial

Université de Sherbrooke1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年1月10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
24
试验地点
1
主要终点
Drug administration appropriate or not

研究概览

简要总结

The purpose of this study is to investigate whether the use of the EZResus app by physicians and nurses reduces medication errors in simulated adult and pediatric resuscitation scenarios compared to the use of standard protocols. This study is a randomized controlled crossover trial with two groups comparing the use of EZResus app with standard protocol in four simulated resuscitation scenarios. The participants will form resuscitation teams, each including an attending physician and two nurses responsible for the preparation and administration of medications. Each team will conduct one adult and one pediatric resuscitation scenario using the EZResus application, along with one adult and one pediatric resuscitation scenario following standard protocols.The teams will be individually randomized to start the scenarios either with or without the medical application using sealed envelopes. The participants will be recruited from one regional hospital (Haut-Richelieu hospital) and one university hospital (Charles LeMoyne Hospital).

详细描述

The simulations will be conducted at the clinical simulation laboratory at Jean-Marc Lepage Pavilion of the University of Sherbrooke using high-fidelity mannequins. During the scenarios, the physician is expected to prescribe medications by mentioning the name, the dose and the route of administration of every medication. Moreover, if multiple dilution for a medication is possible, the physician is expected to mention the desired dilution.

The first pediatric scenario will be a refractory status epilepticus situation where we will evaluate the dosing of benzodiazepines, followed by a 2nd line antiepileptic agent (levetiracetam or phenytoin). If asked, the patient will have hypoglycemia and need IV glucose. The patient will eventually require intubation where we will evaluate the dosage of the induction agent, neuromuscular blocking agent (NMBA), ventilation parameters and intubation equipment (laryngoscope blade and endotracheal tube size). Post intubation, the participant will need to start a perfusion for refractory status epilepticus (midazolam or propofol).

The second pediatric scenario will be a cardiac arrest. The patient will be in ventricular fibrillation and we will evaluate the dosage of epinephrine, antiarrhythmic medication (amiodarone and/or lidocaine) and electric voltage for defibrillation. After return to spontaneous circulation, the patient will require vasopressors (epinephrine perfusion) for hypotension, following PALS guidelines.

The first adult scenario will be a case of calcium channel-blocker toxicity where we will evaluate the dosing of activated charcoal followed by high-dose insulin, dextrose and calcium. The patient will deteriorate and need a vasopressor perfusion and will eventually need intubation where we will evaluate the induction agent, NMBA, ventilation parameters and intubation equipment (laryngoscope blade and endotracheal tube size).

The second adult scenario will be an aortic dissection. We will evaluate the dose of beta blocker (labetalol or esmolol) and the dose of clevidipine, nicardipine or nitroprusside. We will also evaluate the dosage of fentanyl for analgesia.

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 (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •The participants will be recruited from one regional hospital (Haut-Richelieu hospital) and one university hospital (Charles LeMoyne Hospital).
  • •Emergency physicians or emergency nurses working in the resuscitation room and working in one of the two eligible hospital centers.

排除标准

  • •Being part of the research team or affiliated in any way with the EZResus team.

研究组 & 干预措施

Medical calculator application use (EzResus)

Experimental

Participants (physicians and nurses) will be allowed to use a medical calculator application called EzResus. They will receive a 5-minute training prior to the simulations. Participants are also allowed to use other ressources, such as local protocols, medication administration guide.

干预措施: simulation (Behavioral)

Standard care

Active Comparator

Participants are also allowed to use the ressources they use in their practice, apart from a medical calculator application. They are allowed to use local protocols, medication administration guides, medical mobile apps that don't calculate drug doses.

干预措施: simulation (Behavioral)

结局指标

主要结局

Drug administration appropriate or not

时间窗: duration of the simulation: 15-25 minutes per scenario

In this study, the drug administration will be classified as either appropriate or inappropriate, with inappropriate administration being defined by one or more of the following criterias : * the administration of the incorrect medication * the use of an inappropriate route of administration * a prescribed dosage that deviates by more than 10% from the appropriate dose (as defined in the medication tables in appendix) or * an administered dosage that deviates by more than 10% from the prescribed dosage * The omission of a medication considered essential for treatment.

次要结局

  • Drug administration appropriate or not - prescription phase(duration of the simulation: 15-25 minutes per scenario)
  • Drug administration appropriate or not(duration of the simulation: 15-25 minutes per scenario)
  • time to drug prescription(duration of the simulation: 15-25 minutes per scenario)
  • time for drug preparation(duration of the simulation: 15-25 minutes per scenario)
  • time to drug delivery(duration of the simulation: 15-25 minutes per scenario)
  • mental workload(The questionnaire will be administered twice: once after completing two scenarios without the application and once after completing two scenarios with the application)
  • Deviation in endotracheal size(duration of the simulation: 15-25 minutes per scenario)
  • Deviation in laryngoscope blade sizes(duration of the simulation: 15-25 minutes per scenario)
  • Electrical voltage for defibrillation(duration of the simulation: 15-25 minutes per scenario)
  • Ventilatory parameters appropriateness(duration of the simulation: 15-25 minutes per scenario)

研究者

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

Matthieu Vincent

Emergency medicine and Pediatric emergency medicine specialist

Université de Sherbrooke

研究点 (1)

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