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临床试验/NCT07471555
NCT07471555Enrolling By Invitation不适用

Impact of Vascular Access Route and Drug Presentation on Epinephrine Administration Time: A Pilot Study in Clinical Simulation

University of Valencia1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2026年4月2日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
52
试验地点
1
主要终点
Total Time for Epinephrine Administration.

研究概览

简要总结

Rapid administration of epinephrine is an essential component of advanced life support during cardiac arrest. Peripheral intravenous (IV) access is commonly used for drug delivery, while intraosseous (IO) access is an alternative when IV access is not readily available. In addition, epinephrine may be administered using different drug presentations, such as ampoules or prefilled syringes, which may influence procedural workflow during resuscitation.

详细描述

Out-of-hospital cardiac arrest (OHCA) is a time-critical emergency that requires rapid and coordinated interventions by healthcare professionals. Advanced life support protocols emphasize high-quality cardiopulmonary resuscitation, minimization of interruptions, and timely administration of vasoactive medications such as epinephrine in non-shockable rhythms.

Peripheral intravenous (IV) access is frequently used as the initial route for drug administration during cardiac arrest, while intraosseous (IO) access is incorporated into resuscitation algorithms as an alternative when IV access is difficult or delayed. The practical implementation of these access routes may vary depending on operator experience, technical complexity, and clinical context.

In addition to the choice of vascular access, the presentation of emergency medications may affect procedural performance during resuscitation. Epinephrine can be prepared from ampoules or administered using prefilled syringes, each involving different handling steps during emergency care. Evaluating procedural timing across these variables in a controlled environment may provide information relevant to training and workflow optimization.

The purpose of this study is to evaluate the time required to administer 1 mg of epinephrine and the total procedure time according to the vascular access route (IV versus IO) and the drug presentation (ampoule versus prefilled syringe) in a simulated cardiac arrest setting.

Participants will be fourth-year nursing students enrolled during the 2023-2024 academic year. Participation will be voluntary. All participants will receive standardized theoretical and practical training before taking part in the simulation scenarios.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 4th year Nursing students

排除标准

  • 1-2-3 th year Nursing students

研究组 & 干预措施

IV + Ampoule

Experimental

Participants perform intravenous (IV) access and administer epinephrine using a standard glass ampoule.

干预措施: Epinephrine Ampoule (Manual Preparation) (Device)

IV + Ampoule

Experimental

Participants perform intravenous (IV) access and administer epinephrine using a standard glass ampoule.

干预措施: Intravenous (IV) Access (Other)

IV + Prefilled Syringe

Experimental

Participants perform intravenous (IV) access and administer epinephrine using a prefilled syringe.

干预措施: Epinephrine Prefilled Syringe (Ready-to-use) (Device)

IV + Prefilled Syringe

Experimental

Participants perform intravenous (IV) access and administer epinephrine using a prefilled syringe.

干预措施: Intravenous (IV) Access (Other)

IO + Ampoule

Experimental

Participants perform intraosseous (IO) access and administer epinephrine using a standard glass ampoule.

干预措施: Epinephrine Ampoule (Manual Preparation) (Device)

IO + Ampoule

Experimental

Participants perform intraosseous (IO) access and administer epinephrine using a standard glass ampoule.

干预措施: Intraosseous (IO) Access Device (Device)

IO + Prefilled Syringe

Experimental

Participants perform intraosseous (IO) access and administer epinephrine using a prefilled syringe.

干预措施: Epinephrine Prefilled Syringe (Ready-to-use) (Device)

IO + Prefilled Syringe

Experimental

Participants perform intraosseous (IO) access and administer epinephrine using a prefilled syringe.

干预措施: Intraosseous (IO) Access Device (Device)

结局指标

主要结局

Total Time for Epinephrine Administration.

时间窗: During the simulation procedure (Day 1)

The interval of time (in seconds) from the instruction to begin the procedure until the complete administration of 1 mg of epinephrine into the simulation device.

次要结局

  • Time to Successful Vascular Access (Cannulation Time)(During the simulation procedure (Day 1))

研究者

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

María del Carmen Casal Angulo

Associate Professor of Nursing

University of Valencia

研究点 (1)

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