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Completed

NCT Number: NCT06804915

A Mobile App For Drug Dosage Calculation In The Context Of Pediatric And Adult Resuscitation: A Cross-Over Randomized Controlled Trial

The purpose of this study is to investigate whether the use of the EZResus app by physicians and nurses reduces medication errors in simulated adult and pediatric resuscitation scenarios compared to the use of standard protocols. This study is a randomized controlled crossover trial with two groups comparing the use of EZResus app with standard protocol in four simulated resuscitation scenarios. The participants will form resuscitation teams, each including an attending physician and two nurses responsible for the preparation and administration of medications. Each team will conduct one adult and one pediatric resuscitation scenario using the EZResus application, along with one adult and one pediatric resuscitation scenario following standard protocols.The teams will be individually randomized to start the scenarios either with or without the medical application using sealed envelopes. The participants will be recruited from one regional hospital (Haut-Richelieu hospital) and one university hospital (Charles LeMoyne Hospital).

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Key information

Conditions

Mobile App Use in Resuscitation

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Charles-Le Moyne

Greenfield Park, Quebec, J3V 6M6, Canada

About this study

The simulations will be conducted at the clinical simulation laboratory at Jean-Marc Lepage Pavilion of the University of Sherbrooke using high-fidelity mannequins. During the scenarios, the physician is expected to prescribe medications by mentioning the name, the dose and the route of administration of every medication. Moreover, if multiple dilution for a medication is possible, the physician is expected to mention the desired dilution.

The first pediatric scenario will be a refractory status epilepticus situation where we will evaluate the dosing of benzodiazepines, followed by a 2nd line antiepileptic agent (levetiracetam or phenytoin). If asked, the patient will have hypoglycemia and need IV glucose. The patient will eventually require intubation where we will evaluate the dosage of the induction agent, neuromuscular blocking agent (NMBA), ventilation parameters and intubation equipment (laryngoscope blade and endotracheal tube size). Post intubation, the participant will need to start a perfusion for refractory status epilepticus (midazolam or propofol).

The second pediatric scenario will be a cardiac arrest. The patient will be in ventricular fibrillation and we will evaluate the dosage of epinephrine, antiarrhythmic medication (amiodarone and/or lidocaine) and electric voltage for defibrillation. After return to spontaneous circulation, the patient will require vasopressors (epinephrine perfusion) for hypotension, following PALS guidelines.

The first adult scenario will be a case of calcium channel-blocker toxicity where we will evaluate the dosing of activated charcoal followed by high-dose insulin, dextrose and calcium. The patient will deteriorate and need a vasopressor perfusion and will eventually need intubation where we will evaluate the induction agent, NMBA, ventilation parameters and intubation equipment (laryngoscope blade and endotracheal tube size).

The second adult scenario will be an aortic dissection. We will evaluate the dose of beta blocker (labetalol or esmolol) and the dose of clevidipine, nicardipine or nitroprusside. We will also evaluate the dosage of fentanyl for analgesia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The participants will be recruited from one regional hospital (Haut-Richelieu hospital) and one university hospital (Charles LeMoyne Hospital).

  • Emergency physicians or emergency nurses working in the resuscitation room and working in one of the two eligible hospital centers.

Exclusion criteria

  • Being part of the research team or affiliated in any way with the EZResus team.

Treatment and study plan

Simulation

Behavioral

Each team of physician and nurses will participate in 4 scenarios: 2 adult, 2 pediatric. In each scenario, physician and nurses will have a clinical description of the scenario with the age and weight of each patient.

The simulations will be conducted at the clinical simulation laboratory at Jean-Marc Lepage Pavilion of the University of Sherbrooke using high-fidelity mannequins. SimMan 3GPus will be used for adult scenarios and SimJunior for pediatric scenarios, both from Laerdal company. Participants will receive a briefing containing key information about the scenario and the patient just before starting the simulation.

During the scenarios, the physician is expected to prescribe medications by mentioning the name, the dose and the route of administration of every medication. Moreover, if multiple dilution for a medication is possible, the physician is expected to mention the desired dilution.

Primary outcomes

  1. Drug administration appropriate or not

    Time frame: duration of the simulation: 15-25 minutes per scenario

    In this study, the drug administration will be classified as either appropriate or inappropriate, with inappropriate administration being defined by one or more of the following criterias :

    • the administration of the incorrect medication
    • the use of an inappropriate route of administration
    • a prescribed dosage that deviates by more than 10% from the appropriate dose (as defined in the medication tables in appendix) or
    • an administered dosage that deviates by more than 10% from the prescribed dosage
    • The omission of a medication considered essential for treatment.

Secondary outcomes

  1. Drug administration appropriate or not - prescription phase

    Time frame: duration of the simulation: 15-25 minutes per scenario

    As defined for the primary outcome measure, error occurring during the prescription, either from a verbal prescription or written prescription

  2. Drug administration appropriate or not

    Time frame: duration of the simulation: 15-25 minutes per scenario

    As defined for the primary outcome measure. Error occurring during the administration phase.

  3. time to drug prescription

    Time frame: duration of the simulation: 15-25 minutes per scenario

    measured from the beginning of the scenario to the physician's verbal prescription (defined as the first mention of the drug's name)

  4. time for drug preparation

    Time frame: duration of the simulation: 15-25 minutes per scenario

    measured from the physician's verbal prescription to the start of drug preparation by the nurse

  5. time to drug delivery

    Time frame: duration of the simulation: 15-25 minutes per scenario

    measured from the verbal prescription to the beginning of administration of the drug

  6. mental workload

    Time frame: The questionnaire will be administered twice: once after completing two scenarios without the application and once after completing two scenarios with the application

    will be assessed using the simplified NASA Task Load Index method, which employs a questionnaire featuring five 7-point scales, rating performance across six dimensions: mental demand, physical demand, temporal demand, effort, performance and frustration level.

  7. Deviation in endotracheal size

    Time frame: duration of the simulation: 15-25 minutes per scenario

    In some scenarios, whenever a pediatric simulated patient is intubated.

  8. Deviation in laryngoscope blade sizes

    Time frame: duration of the simulation: 15-25 minutes per scenario

    Apply to the 2 pediatric scenarios

  9. Electrical voltage for defibrillation

    Time frame: duration of the simulation: 15-25 minutes per scenario

    Electrical voltage for defibrillation - whether accurate or innacurrate

  10. Ventilatory parameters appropriateness

    Time frame: duration of the simulation: 15-25 minutes per scenario

    appropriateness of volumes and respiratory rates

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 3, 2025
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.