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To Compare the Time Required to Administer 1 mg of Epinephrine, as Well as the Total ProcedureIO_nursingNCT07471555

Vascular Access and Intraosseus

A study testing Epinephrine Ampoule (Manual Preparation), Epinephrine Prefilled Syringe (Ready-to-use) and Intravenous (IV) Access in people with To Compare the Time Required to Administer 1 mg of Epinephrine, as Well as the Total Procedure, run by University of Valencia at 1 site in Spain.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Epinephrine Ampoule (Manual Preparation), Epinephrine Prefilled Syringe (Ready-to-use) and Intravenous (IV) Access
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteSpain
Study dates
2 Apr 2026to 3 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 4th year Nursing students

Who cannot join

  • 1-2-3 th year Nursing students

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Spain1 site
  • Faculty of Nursing and Podiatry

    Valencia, Valencia, 46010

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Being tested
Epinephrine Ampoule (Manual Preparation), Epinephrine Prefilled Syringe (Ready-to-use), Intravenous (IV) Access, Intraosseous (IO) Access Device
Keywords
Vascular Access Devices, simulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Epinephrine Ampoule (Manual Preparation)Device

    Standard 1 mg/mL glass ampoule requiring manual aspiration with a needle and syringe before administration.

  • Epinephrine Prefilled Syringe (Ready-to-use)Device

    Ready-to-use 1 mg/10 mL prefilled syringe system for immediate administration.

  • Intravenous (IV) AccessOther

    Peripheral venous cannulation procedure.

  • Intraosseous (IO) Access DeviceDevice

    Manual or powered intraosseous drill/needle for vascular access.

Study groups in NCT07471555
Study groupRoleWhat they receive
IV + AmpouleExperimentalParticipants perform intravenous (IV) access and administer epinephrine using a standard glass ampoule.
Receives: Device: Epinephrine Ampoule (Manual Preparation); Other: Intravenous (IV) Access
IV + Prefilled SyringeExperimentalParticipants perform intravenous (IV) access and administer epinephrine using a prefilled syringe.
Receives: Device: Epinephrine Prefilled Syringe (Ready-to-use); Other: Intravenous (IV) Access
IO + AmpouleExperimentalParticipants perform intraosseous (IO) access and administer epinephrine using a standard glass ampoule.
Receives: Device: Epinephrine Ampoule (Manual Preparation); Device: Intraosseous (IO) Access Device
IO + Prefilled SyringeExperimentalParticipants perform intraosseous (IO) access and administer epinephrine using a prefilled syringe.
Receives: Device: Epinephrine Prefilled Syringe (Ready-to-use); Device: Intraosseous (IO) Access Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: During the simulation procedure (Day 1)

Secondary outcomes (1)
  1. 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.

    Measured: During the simulation procedure (Day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2026
  2. Study start2 Apr 2026 (estimated)
  3. Primary completion3 Jul 2026 (estimated)
  4. Study completion3 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07471555
Sponsor's protocol ID
UV-INV_ETICA-3080049.
Other IDs
UV-INV_ETICA-3080049.
Acronym
IO_nursing
Status last verified
Mar 2026
First submitted
8 Jan 2026
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 36806977

Questions about this trial

What is this clinical trial studying?

A study testing Epinephrine Ampoule (Manual Preparation), Epinephrine Prefilled Syringe (Ready-to-use) and Intravenous (IV) Access in people with To Compare the Time Required to Administer 1 mg of Epinephrine, as Well as the Total Procedure, run by University of Valencia at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Time for Epinephrine Administration. (time frame: During the simulation procedure (Day 1)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07471555, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.

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