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.
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
- Conditions the study is for
- To Compare the Time Required to Administer 1 mg of Epinephrine, as Well as the Total Procedure
- What is being tested?
- Epinephrine Ampoule (Manual Preparation), Epinephrine Prefilled Syringe (Ready-to-use) and Intravenous (IV) Access
- Type of treatment
- Injection or infusion, Medical device
- 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.
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.
- Conditions
- To Compare the Time Required to Administer 1 mg of Epinephrine, as Well as the Total Procedure
- 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 group | Role | What they receive |
|---|---|---|
| IV + Ampoule | Experimental | Participants perform intravenous (IV) access and administer epinephrine using a standard glass ampoule. Receives: Device: Epinephrine Ampoule (Manual Preparation); Other: Intravenous (IV) Access |
| IV + Prefilled Syringe | Experimental | Participants perform intravenous (IV) access and administer epinephrine using a prefilled syringe. Receives: Device: Epinephrine Prefilled Syringe (Ready-to-use); Other: Intravenous (IV) Access |
| IO + Ampoule | Experimental | Participants 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 Syringe | Experimental | Participants 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.
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)
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.
- First posted13 Mar 2026
- Study start2 Apr 2026 (estimated)
- Primary completion3 Jul 2026 (estimated)
- Study completion3 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for To Compare the Time Required to Administer 1 mg of Epinephrine, as Well as the Total ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María del Carmen Casal Angulo, University of Valencia
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vascular Access Route and Drug Presentation on Epinephrine Administration Time: A Pilot Study in Clinical Simulation
- ClinicalTrials.gov ID
- NCT07471555
- Acronym / sponsor ID
- IO_nursing / UV-INV_ETICA-3080049.
- Conditions
- To Compare the Time Required to Administer 1 mg of Epinephrine, as Well as the Total Procedure
- Keywords
- Vascular Access Devices, simulation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 2 Apr 2026 (estimated)
- Primary completion
- 3 Jul 2026 (estimated)
- Study completion
- 3 Dec 2026 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IV + Ampoule | Experimental | Device: Epinephrine Ampoule (Manual Preparation), Other: Intravenous (IV) AccessParticipants perform intravenous (IV) access and administer epinephrine using a standard glass ampoule. |
| IV + Prefilled Syringe | Experimental | Device: Epinephrine Prefilled Syringe (Ready-to-use), Other: Intravenous (IV) AccessParticipants perform intravenous (IV) access and administer epinephrine using a prefilled syringe. |
| IO + Ampoule | Experimental | Device: Epinephrine Ampoule (Manual Preparation), Device: Intraosseous (IO) Access DeviceParticipants perform intraosseous (IO) access and administer epinephrine using a standard glass ampoule. |
| IO + Prefilled Syringe | Experimental | Device: Epinephrine Prefilled Syringe (Ready-to-use), Device: Intraosseous (IO) Access DeviceParticipants perform intraosseous (IO) access and administer epinephrine using a prefilled syringe. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 4th year Nursing students
Key exclusion criteria (1 listed)
- 1-2-3 th year Nursing students
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epinephrine Ampoule (Manual Preparation)Standard 1 mg/mL glass ampoule requiring manual aspiration with a needle and syringe before administration. | Device | IO + Ampoule, IV + Ampoule |
| Epinephrine Prefilled Syringe (Ready-to-use)Ready-to-use 1 mg/10 mL prefilled syringe system for immediate administration. | Device | IO + Prefilled Syringe, IV + Prefilled Syringe |
| Intravenous (IV) AccessPeripheral venous cannulation procedure. | Other | IV + Ampoule, IV + Prefilled Syringe |
| Intraosseous (IO) Access DeviceManual or powered intraosseous drill/needle for vascular access. | Device | IO + Ampoule, IO + Prefilled Syringe |
Primary outcome
Total Time for Epinephrine Administration.
Time frame: 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.
1 secondary outcome
Time to Successful Vascular Access (Cannulation Time)
Time frame: During the simulation procedure (Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 36806977Yang 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.