Mobile App Use in ResuscitationNCT06804915
A Mobile App For Drug Dosage Calculation In The Context Of Pediatric And Adult Resuscitation: A Cross-Over Randomized Controlled Trial
A study testing simulation in people with Mobile App Use in Resuscitation, run by Université de Sherbrooke at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mobile App Use in Resuscitation
- What is being tested?
- simulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jan 2025to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Being part of the research team or affiliated in any way with the EZResus team.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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
- Being tested
- simulation
- Keywords
- mobile app, smartphone, resuscitation, drug errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simulationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Medical calculator application use (EzResus) | Experimental | 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. Receives: Behavioral: simulation |
| Standard care | Active comparator | 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. Receives: Behavioral: simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: duration of the simulation: 15-25 minutes per scenario
Secondary outcomes (10)
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
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: duration of the simulation: 15-25 minutes per scenario
Deviation in laryngoscope blade sizes
Apply to the 2 pediatric scenarios
Measured: duration of the simulation: 15-25 minutes per scenario
Electrical voltage for defibrillation
Electrical voltage for defibrillation - whether accurate or innacurrate
Measured: duration of the simulation: 15-25 minutes per scenario
Ventilatory parameters appropriateness
appropriateness of volumes and respiratory rates
Measured: duration of the simulation: 15-25 minutes per scenario
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start10 Jan 2025
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mobile App Use in ResuscitationStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthieu Vincent, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804915
- Sponsor's protocol ID
- 2025-922
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all requested data
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile App For Drug Dosage Calculation In The Context Of Pediatric And Adult Resuscitation: A Cross-Over Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06804915
- Acronym / sponsor ID
- 2025-922
- Conditions
- Mobile App Use in Resuscitation
- Keywords
- mobile app, smartphone, resuscitation, drug errors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Medical calculator application use (EzResus) | Experimental | Behavioral: simulationParticipants (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. |
| Standard care | Active comparator | Behavioral: simulationParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Being part of the research team or affiliated in any way with the EZResus team.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| simulationEach 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. | Behavioural | Medical calculator application use (EzResus), Standard care |
Primary outcome
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.
10 secondary outcomes
Drug administration appropriate or not - prescription phase
Time frame: duration of the simulation: 15-25 minutes per scenario
Drug administration appropriate or not
Time frame: duration of the simulation: 15-25 minutes per scenario
time to drug prescription
Time frame: duration of the simulation: 15-25 minutes per scenario
time for drug preparation
Time frame: duration of the simulation: 15-25 minutes per scenario
time to drug delivery
Time frame: duration of the simulation: 15-25 minutes per scenario
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
Deviation in endotracheal size
Time frame: duration of the simulation: 15-25 minutes per scenario
Deviation in laryngoscope blade sizes
Time frame: duration of the simulation: 15-25 minutes per scenario
Electrical voltage for defibrillation
Time frame: duration of the simulation: 15-25 minutes per scenario
Ventilatory parameters appropriateness
Time frame: duration of the simulation: 15-25 minutes per scenario
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Individual participant dataSharing planned: Yes. all requested data
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing simulation in people with Mobile App Use in Resuscitation, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug administration appropriate or not (time frame: duration of the simulation: 15-25 minutes per scenario). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.