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Enrolling by invitation NCT07471555

Vascular Access and Intraosseus

No phase Interventional To Compare the Time Required to Administer 1 mg of Epinephrine, as Well as the Total Procedure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Epinephrine Ampoule (Manual Preparation), Epinephrine Prefilled Syringe (Ready-to-use), Intravenous (IV) Access, Intraosseous (IO) Access Device.
Who it may be relevant to
Registry conditions: To Compare the Time Required to Administer 1 mg of Epinephrine, as Well as the Total Procedure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

The intervention consists of a 4-hour theoretical-practical training session. The theoretical component will cover the principles, indications, and procedural steps of peripheral intravenous and intraosseous access. The practical component will involve supervised hands-on training in a simulation laboratory. Peripheral IV access will be practiced using an adult intravenous training arm (Multi-venous IV training arm adult, Laerdal®). Intraosseous access will be practiced using porcine tibias as an anatomical model.

Following training, participants will perform simulated epinephrine administration scenarios according to their randomized allocation. The primary variable recorded will be the time from the start of the procedure to the administration of 1 mg of epinephrine. Additional procedural timing variables will be collected to characterize the drug administration process under standardized simulation conditions.

Interventions

  • Device Epinephrine Ampoule (Manual Preparation)
    Standard 1 mg/mL glass ampoule requiring manual aspiration with a needle and syringe before administration.
  • Device Epinephrine Prefilled Syringe (Ready-to-use)
    Ready-to-use 1 mg/10 mL prefilled syringe system for immediate administration.
  • Other Intravenous (IV) Access
    Peripheral venous cannulation procedure.
  • Device Intraosseous (IO) Access Device
    Manual or powered intraosseous drill/needle for vascular access.

Primary outcome measures

  • Total Time for Epinephrine Administration. [Time frame: During the simulation procedure (Day 1)]
Secondary outcome measures (1)
  • Time to Successful Vascular Access (Cannulation Time) [Time frame: During the simulation procedure (Day 1)]

Eligibility criteria

Inclusion criteria

  • 4th year Nursing students

Exclusion criteria

  • 1-2-3 th year Nursing students

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Spain · 1 center
  • Faculty of Nursing and Podiatry — Valencia

Publications

  • Yang SC, Hsu YH, Chang YH, Chien LT, Chen IC, Chiang WC. Epinephrine administration in adults with out-of-hospital cardiac arrest: A comparison between intraosseous and intravenous route. Am J Emerg Med. 2023 May;67:63-69. doi: 10.1016/j.ajem.2023.02.003. Epub 2023 Feb 7. PMID 36806977

Identifiers

NCT: NCT07471555 · UV-INV_ETICA-3080049. · UV-INV_ETICA-3080049.

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗