Pediatric Emergency MedicineNCT06129370
Testing of Medication Dosing Software
A study testing Standard practice and Medication dosing software in people with Pediatric Emergency Medicine, run by Nura Medical.
Trial summary
The goal of this clinical study is to evaluate the clinical efficiency of a medication dosing software in simulated pediatric emergency care. The main questions it aims to answer are: Will the time to patient be significantly reduced with the medication dosage software when compared to standard clinical practice? Will… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Emergency Medicine
- What is being tested?
- Standard practice and Medication dosing software
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Apr 2024
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -Healthcare professionals who have worked or who are currently working at a healthcare facility and involved in the calculation or preparation of IV medication.
Who cannot join
- Healthcare professionals who cannot read, speak, or understand English or French as the simulations will be conducted in English or French.
- Performance of physically strenuous activity 30 min prior to study.
- Physical limitations that affect performance on required tasks (e.g., inability to place arm cuff on mannequin's arm, inability to handle weight estimation and touchscreen devices).
About this study
Official title: Testing of a Medication Dosing Software for Pediatric Emergency Care
The goal of this clinical study is to evaluate the clinical efficiency of a medication dosing software in simulated pediatric emergency care. The main questions it aims to answer are:
- Will the time to patient be significantly reduced with the medication dosage software when compared to standard clinical practice?
- Will the time to calculate dosage of medications be significantly reduced with the medication dosage software when compared to standard clinical practice?
- How will users perceive clinical efficiency, ease of use, confidence level of using the medication dosage software when compared to standard clinical practice?
- How will accuracy of medication dose and volume calculations as well as final volume ready for administration using the medication dosage software compared to standard clinical practice?
- Will the time spent calculating medication doses by the second healthcare professional on pediatric non-acute and acute care cases be significantly reduced with the medication dosage software when compared to standard clinical practice?
Participants will be presented pediatric care scenarios and asked to calculate and prepare intravenous medications under two interventions: the medication dosage software and standard clinical practice (Lexicomp and manual calculator).
- Conditions
- Pediatric Emergency Medicine
- Being tested
- Standard practice, Medication dosing software
- Keywords
- Simulation, Pediatric emergency care, Healthcare professionals, Medication errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard practiceDevice
Lexicomp and manual calculator
Medication dosing softwareDevice
Medication dosing software
| Study group | Role | What they receive |
|---|---|---|
| Software, then Standard | Experimental | Participants will use the medication dosage software to calculate and prepare intravenous medications during the initial run through of pediatric case scenarios. Then, they will use standard clinical practice (Lexicomp and manual calculator) during the second run through of pediatric case scenarios. Receives: Device: Standard practice; Device: Medication dosing software |
| Standard, then Software | Experimental | Participants will use standard clinical practice (Lexicomp and manual calculator) to calculate and prepare intravenous medications during the initial run through of pediatric case scenarios. Then, they will use the medication dosage software during the second run through of pediatric case scenarios. Receives: Device: Standard practice; Device: Medication dosing software |
What is being measured
The primary outcome is the main question the study is designed to answer.
TIme to patient
Assess the time elapsed from ordering of medication to ready for administration using the medication dosage software compared to the time achieved with standard clinical practice
Measured: Through study completion, up to 3 months
Time to calculate
Assess the time to calculate medication dosage using the medication dosage software compared to standard clinical practice
Measured: Through study completion, up to 3 months
Secondary outcomes (3)
Feedback
time to calculate medication dosage using the medication dosage software compared to standard clinical practice
Measured: Through study completion, up to 3 months
Accuracy
To assess the accuracy of (I) medication dose and volume calculations and (II) final volume ready for administration using the medication dosage software compared to standard clinical practice.
Measured: Through study completion, up to 3 months
Time of calculation by second healthcare professional
To assess the time spent calculating medication dosages by the second healthcare professional.
Measured: Through study completion, up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study startDec 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Emergency MedicineStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nura Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129370
- Sponsor's protocol ID
- 2024-10183
- Status last verified
- Nov 2023
- First submitted
- 3 Nov 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing of a Medication Dosing Software for Pediatric Emergency Care
- ClinicalTrials.gov ID
- NCT06129370
- Acronym / sponsor ID
- 2024-10183
- Conditions
- Pediatric Emergency Medicine
- Keywords
- Simulation, Pediatric emergency care, Healthcare professionals, Medication errors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Nura MedicalIndustry (pharma, biotech, devices)
- Study start
- Dec 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 13 Nov 2023 (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 goal of this clinical study is to evaluate the clinical efficiency of a medication dosing software in simulated pediatric emergency care. The main questions it aims to answer are:
- Will the time to patient be significantly reduced with the medication dosage software when compared to standard clinical practice?
- Will the time to calculate dosage of medications be significantly reduced with the medication dosage software when compared to standard clinical practice?
- How will users perceive clinical efficiency, ease of use, confidence level of using the medication dosage software when compared to standard clinical practice?
- How will accuracy of medication dose and volume calculations as well as final volume ready for administration using the medication dosage software compared to standard clinical practice?
- Will the time spent calculating medication doses by the second healthcare professional on pediatric non-acute and acute care cases be significantly reduced with the medication dosage software when compared to standard clinical practice?
Participants will be presented pediatric care scenarios and asked to calculate and prepare intravenous medications under two interventions: the medication dosage software and standard clinical practice (Lexicomp and manual calculator).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Software, then Standard | Experimental | Device: Standard practice, Device: Medication dosing softwareParticipants will use the medication dosage software to calculate and prepare intravenous medications during the initial run through of pediatric case scenarios. Then, they will use standard clinical practice (Lexicomp and manual calculator) during the second run through of pediatric case scenarios. |
| Standard, then Software | Experimental | Device: Standard practice, Device: Medication dosing softwareParticipants will use standard clinical practice (Lexicomp and manual calculator) to calculate and prepare intravenous medications during the initial run through of pediatric case scenarios. Then, they will use the medication dosage software during the second run through of pediatric case scenarios. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -Healthcare professionals who have worked or who are currently working at a healthcare facility and involved in the calculation or preparation of IV medication.
Key exclusion criteria (3 listed)
- Healthcare professionals who cannot read, speak, or understand English or French as the simulations will be conducted in English or French.
- Performance of physically strenuous activity 30 min prior to study.
- Physical limitations that affect performance on required tasks (e.g., inability to place arm cuff on mannequin's arm, inability to handle weight estimation and touchscreen devices).
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 |
|---|---|---|
| Standard practiceLexicomp and manual calculator | Device | Software, then Standard, Standard, then Software |
| Medication dosing softwareMedication dosing software | Device | Software, then Standard, Standard, then Software |
Primary outcome
TIme to patient
Time frame: Through study completion, up to 3 months
Assess the time elapsed from ordering of medication to ready for administration using the medication dosage software compared to the time achieved with standard clinical practice
Time to calculate
Time frame: Through study completion, up to 3 months
Assess the time to calculate medication dosage using the medication dosage software compared to standard clinical practice
3 secondary outcomes
Feedback
Time frame: Through study completion, up to 3 months
Accuracy
Time frame: Through study completion, up to 3 months
Time of calculation by second healthcare professional
Time frame: Through study completion, up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Standard practice and Medication dosing software in people with Pediatric Emergency Medicine, run by Nura Medical.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
TIme to patient (time frame: Through study completion, up to 3 months). The study lists 2 primary outcomes in all. 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 13 Nov 2023.