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).

Study Overview

• Status: Completed
• Conditions: Mobile App Use in Resuscitation
• Intervention / Treatment: Behavioral: simulation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Greenfield Park, Quebec, Canada, J3V 6M6
      • Hôpital Charles-Le Moyne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medical calculator application use (EzResus); Participants (physicians and nurses) will be allowed to use a medical calculator application called EzResus. They will receive a 5-minute training prior to the simulations. Participants are also allowed to use other ressources, such as local protocols, medication administration guide.	Behavioral: simulation; 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.
Active Comparator: Standard care; Participants are also allowed to use the ressources they use in their practice, apart from a medical calculator application. They are allowed to use local protocols, medication administration guides, medical mobile apps that don't calculate drug doses.	Behavioral: simulation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug administration appropriate or not	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.	duration of the simulation: 15-25 minutes per scenario

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug administration appropriate or not - prescription phase	As defined for the primary outcome measure, error occurring during the prescription, either from a verbal prescription or written prescription	duration of the simulation: 15-25 minutes per scenario
Drug administration appropriate or not	As defined for the primary outcome measure. Error occurring during the administration phase.	duration of the simulation: 15-25 minutes per scenario
time to drug prescription	measured from the beginning of the scenario to the physician's verbal prescription (defined as the first mention of the drug's name)	duration of the simulation: 15-25 minutes per scenario
time for drug preparation	measured from the physician's verbal prescription to the start of drug preparation by the nurse	duration of the simulation: 15-25 minutes per scenario
time to drug delivery	measured from the verbal prescription to the beginning of administration of the drug	duration of the simulation: 15-25 minutes per scenario
mental workload	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.	The questionnaire will be administered twice: once after completing two scenarios without the application and once after completing two scenarios with the application
Deviation in endotracheal size	In some scenarios, whenever a pediatric simulated patient is intubated.	duration of the simulation: 15-25 minutes per scenario
Deviation in laryngoscope blade sizes	Apply to the 2 pediatric scenarios	duration of the simulation: 15-25 minutes per scenario
Electrical voltage for defibrillation	Electrical voltage for defibrillation - whether accurate or innacurrate	duration of the simulation: 15-25 minutes per scenario
Ventilatory parameters appropriateness	appropriateness of volumes and respiratory rates	duration of the simulation: 15-25 minutes per scenario

Collaborators and Investigators

• Sponsor: Université de Sherbrooke

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2025
• Primary Completion (Actual): January 15, 2025
• Study Completion (Actual): January 15, 2025

Study Registration Dates

• First Submitted: January 10, 2025
• First Submitted That Met QC Criteria: January 27, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: smartphone; resuscitation; mobile app; drug errors
• Other Study ID Numbers: 2025-922

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all requested data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No