A Mobile App for Drug Dosage Calculation in the Context of Pediatric and Adult Resuscitation: a Cross-Over Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Mobile App Use in Resuscitation

• Registration Number: NCT06804915
• Lead Sponsor: Université de Sherbrooke

Brief Summary

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).

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 Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-10
• Study First Submitted: 2025-01-10
• Primary Completion: 2025-01-15
• Study Completion: 2025-01-15
• Study First Submitted QC: 2025-01-27
• Last Update Submitted: 2025-01-27
• Study First Posted: 2025-02-03
• Last Update Posted: 2025-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Drug administration appropriate or not	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 Outcome Measures

Name	Time	Method
Drug administration appropriate or not - prescription phase	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
Drug administration appropriate or not	duration of the simulation: 15-25 minutes per scenario	As defined for the primary outcome measure. Error occurring during the administration phase.
time to drug prescription	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)
time for drug preparation	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
time to drug delivery	duration of the simulation: 15-25 minutes per scenario	measured from the verbal prescription to the beginning of administration of the drug
mental workload	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.
Deviation in endotracheal size	duration of the simulation: 15-25 minutes per scenario	In some scenarios, whenever a pediatric simulated patient is intubated.
Deviation in laryngoscope blade sizes	duration of the simulation: 15-25 minutes per scenario	Apply to the 2 pediatric scenarios
Electrical voltage for defibrillation	duration of the simulation: 15-25 minutes per scenario	Electrical voltage for defibrillation - whether accurate or innacurrate
Ventilatory parameters appropriateness	duration of the simulation: 15-25 minutes per scenario	appropriateness of volumes and respiratory rates

Trial Locations

Locations (1)

Hôpital Charles-Le Moyne; 🇨🇦 Greenfield Park, Quebec, Canada