Testing of Medication Dosing Software

Pediatric Emergency Medicine Clinical Trial

Official title:

Testing of a Medication Dosing Software for Pediatric Emergency Care

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06129370
• Other study ID #: 2024-10183
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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).

Related Conditions & MeSH terms

• Emergencies
• Pediatric Emergency Medicine

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