Clinical trial NCT06804915: A Mobile App For Drug Dosage Calculation In The Context Of Pediatric And Adult Resuscitation: A Cross-Over Randomized Controlled Trial
Official title: A Mobile App For Drug Dosage Calculation In The Context Of Pediatric And Adult Resuscitation: A Cross-Over Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mobile App Use in Resuscitation
Keywords: mobile app
smartphone
resuscitation
drug errors
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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. Standard protocol is defined as standard care using any resources usually used by professionals, except for medical calculator applications.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Drug administration appropriate or not
timeFrame: duration of the simulation: 15-25 minutes per scenario
Secondary outcomes:
measure: Drug administration appropriate or not - prescription phase
timeFrame: duration of the simulation: 15-25 minutes per scenario
measure: Drug administration appropriate or not
timeFrame: duration of the simulation: 15-25 minutes per scenario
measure: time to drug prescription
timeFrame: duration of the simulation: 15-25 minutes per scenario
measure: time for drug preparation
timeFrame: duration of the simulation: 15-25 minutes per scenario
measure: time to drug delivery
timeFrame: duration of the simulation: 15-25 minutes per scenario
measure: mental workload
timeFrame: The questionnaire will be administered twice: once after completing two scenarios without the application and once after completing two scenarios with the application
measure: Deviation in endotracheal size
timeFrame: duration of the simulation: 15-25 minutes per scenario
measure: Deviation in laryngoscope blade sizes
timeFrame: duration of the simulation: 15-25 minutes per scenario
measure: Electrical voltage for defibrillation
timeFrame: duration of the simulation: 15-25 minutes per scenario
measure: Ventilatory parameters appropriateness
timeFrame: duration of the simulation: 15-25 minutes per scenario
Other outcomes:
Locations:
city: Greenfield Park
country: Canada
facility: Hôpital Charles-Le Moyne
state: Quebec
Study officials:
References: