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

NCT ID: NCT06804915

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-10
• Study Completion Date: 2025-01-15

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.

Conditions

Mobile App Use in Resuscitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

simulation

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

simulation

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Université de Sherbrooke

OTHER

Sponsor Role: lead

Responsible Party

Matthieu Vincent

Emergency medicine and Pediatric emergency medicine specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hôpital Charles-Le Moyne

Greenfield Park, Quebec, Canada

Countries

Canada

Other Identifiers

2025-922

Identifier Type: -

Identifier Source: org_study_id