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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06129370
Other study ID # 2024-10183
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 2023
Est. completion date April 2024

Study information

Verified date November 2023
Source Nura Medical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 12
Est. completion date April 2024
Est. primary completion date March 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: -Healthcare professionals who have worked or who are currently working at a healthcare facility and involved in the calculation or preparation of IV medication. Exclusion Criteria: - 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).

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Standard practice
Lexicomp and manual calculator
Medication dosing software
Medication dosing software

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Nura Medical

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Through study completion, up to 3 months
Primary Time to calculate Assess the time to calculate medication dosage using the medication dosage software compared to standard clinical practice Through study completion, up to 3 months
Secondary Feedback time to calculate medication dosage using the medication dosage software compared to standard clinical practice Through study completion, up to 3 months
Secondary 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. Through study completion, up to 3 months
Secondary Time of calculation by second healthcare professional To assess the time spent calculating medication dosages by the second healthcare professional. Through study completion, up to 3 months
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