Vascular Access and Intraosseus (IO_nursing)

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: To Compare the Time Required to Administer 1 mg of Epinephrine, as Well as the Total Procedure
• Intervention / Treatment: Device: Epinephrine Ampoule (Manual Preparation); Other: Intravenous (IV) Access; Device: Epinephrine Prefilled Syringe (Ready-to-use); Device: Intraosseous (IO) Access Device

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.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia
    • Valencia, Valencia, Spain, 46010
      • Faculty of Nursing and Podiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 4th year Nursing students

Exclusion Criteria:

• 1-2-3 th year Nursing students

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IV + Ampoule; Participants perform intravenous (IV) access and administer epinephrine using a standard glass ampoule.	Device: Epinephrine Ampoule (Manual Preparation); Standard 1 mg/mL glass ampoule requiring manual aspiration with a needle and syringe before administration.; Other: Intravenous (IV) Access; Peripheral venous cannulation procedure.
Experimental: IV + Prefilled Syringe; Participants perform intravenous (IV) access and administer epinephrine using a prefilled syringe.	Other: Intravenous (IV) Access; Peripheral venous cannulation procedure.; Device: Epinephrine Prefilled Syringe (Ready-to-use); Ready-to-use 1 mg/10 mL prefilled syringe system for immediate administration.
Experimental: IO + Ampoule; Participants perform intraosseous (IO) access and administer epinephrine using a standard glass ampoule.	Device: Epinephrine Ampoule (Manual Preparation); Standard 1 mg/mL glass ampoule requiring manual aspiration with a needle and syringe before administration.; Device: Intraosseous (IO) Access Device; Manual or powered intraosseous drill/needle for vascular access.
Experimental: IO + Prefilled Syringe; Participants perform intraosseous (IO) access and administer epinephrine using a prefilled syringe.	Device: Epinephrine Prefilled Syringe (Ready-to-use); Ready-to-use 1 mg/10 mL prefilled syringe system for immediate administration.; Device: Intraosseous (IO) Access Device; Manual or powered intraosseous drill/needle for vascular access.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Time for Epinephrine Administration.	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.	During the simulation procedure (Day 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Successful Vascular Access (Cannulation Time)	The interval of time (in seconds) from the instruction to begin the procedure until successful vascular access (cannulation) is achieved in the simulation model.	During the simulation procedure (Day 1)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug Administration Time	The interval of time (in seconds) from the moment successful vascular access is achieved until the complete administration of the medication.	During the simulation procedure (Day 1)

Collaborators and Investigators

• Sponsor: University of Valencia

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 2, 2026
• Primary Completion (Estimated): July 3, 2026
• Study Completion (Estimated): December 3, 2026

Study Registration Dates

• First Submitted: January 8, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: simulation; Vascular Access Devices
• Other Study ID Numbers: UV-INV_ETICA-3080049. (Other Identifier: University of Valencia)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No