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N/A N=150 Randomized Single-blind Treatment

Reducing Prehospital Medication Errors & Time to Drug Delivery by EMS During Simulated Pediatric CPR

Cardiopulmonary Arrest · Resuscitation · Pediatrics · Medication Errors · Emergency Medical Services

Enrolled (actual)
150
Serious AEs
Results posted
Oct 2024
Primary outcome: Primary: Medication Dosage Errors — 5.7; 62.8 percentage of medication errors

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Mobile device app (PedAMINES™) 1st drug (Device); Mobile device app (PedAMINES™) 2nd drug (Device); Mobile device app (PedAMINES™) 3rd drug (Device); Mobile device app (PedAMINES™) 4th drug (Device); Conventional method 1st drug (Device); Conventional method 2nd drug (Device); Conventional method 3rd drug (Device); Conventional method 4th drug (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Pediatric Clinical Research Platform
Primary completion
Jan 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Medication Dosage Errors
5.7; 62.8
SECONDARY
Time to Drug Preparation and Time to Drug Delivery
146.6; 186.1; 186.8; 233.3
SECONDARY
Type of Medication Errors
17; 191; 16; 172; 0; 55
SECONDARY
Perceived Stress
36.1; 35.4; 39.0; 49.8; 4.2; 3.9
SECONDARY
Stress Level Measured by Heart Rate Monitoring (Smartwatch).
79.3; 78.5; 123.1; 124.1; 121.1; 119.9
SECONDARY
Unified Theory of Acceptance and Use of Technology (UTAUT) Questionnaire and System Usability Score (SUS)
4.69; 4.61; 4.49; 4.55; 4.74; 4.14

Summary

The study investigators will recruit paramedics in many Emergency Medical Services (EMS) in Switzerland to prepare direct intravenous (IV) emergency drugs during a standardized simulation-based pediatric out-of-hospital cardiac arrest scenario. According to randomization, each paramedic will be asked to prepare sequentially 4 IV emergency drugs (epinephrine, midazolam, dextrose 10%, sodium bicarbonate 4.2%) following either their current conventional methods or by the aim of a mobile device app. This app is designed to support drug preparation at pediatric dosages. In a previous multicenter randomized trial with nurses, the investigators reported the ability of this app to significantly reduce in-hospital continuous infusion medication error rates and drug preparation time compared to conventional preparation methods during simulation-based resuscitations. In this trial, the aim was to assess this app during pediatric out-of-hospital cardiopulmonary resuscitation with paramedics.

Eligibility Criteria

Inclusion Criteria

  • To be paramedic certified
  • To know how to prepare direct IV drugs
  • To have previously completed the 5-minute introductory course to the use of the app PedAMINES™ dispensed by the study investigators
  • Participation agreement

Exclusion Criteria

  • To have at any time previously used the app PedAMINES™
  • To have not undergone the 5-minute introductory course to the use of the app PedAMINES™
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03921346). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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