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Vascular Access and Intraosseus (IO_nursing)

U

University of Valencia

Status

Invitation-only

Conditions

To Compare the Time Required to Administer 1 mg of Epinephrine, as Well as the Total Procedure

Treatments

Other: Intravenous (IV) Access
Device: Intraosseous (IO) Access Device
Device: Epinephrine Ampoule (Manual Preparation)
Device: Epinephrine Prefilled Syringe (Ready-to-use)

Study type

Interventional

Funder types

Other

Identifiers

NCT07471555
UV-INV_ETICA-3080049. (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

52 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 4th year Nursing students

Exclusion criteria

  • 1-2-3 th year Nursing students

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

52 participants in 4 patient groups

IV + Ampoule
Experimental group
Description:
Participants perform intravenous (IV) access and administer epinephrine using a standard glass ampoule.
Treatment:
Device: Epinephrine Ampoule (Manual Preparation)
Other: Intravenous (IV) Access
IV + Prefilled Syringe
Experimental group
Description:
Participants perform intravenous (IV) access and administer epinephrine using a prefilled syringe.
Treatment:
Device: Epinephrine Prefilled Syringe (Ready-to-use)
Other: Intravenous (IV) Access
IO + Ampoule
Experimental group
Description:
Participants perform intraosseous (IO) access and administer epinephrine using a standard glass ampoule.
Treatment:
Device: Epinephrine Ampoule (Manual Preparation)
Device: Intraosseous (IO) Access Device
IO + Prefilled Syringe
Experimental group
Description:
Participants perform intraosseous (IO) access and administer epinephrine using a prefilled syringe.
Treatment:
Device: Epinephrine Prefilled Syringe (Ready-to-use)
Device: Intraosseous (IO) Access Device

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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