CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 150 enrolled
Drug / intervention
Mobile device app (PedAMINES™) 1st drug +7 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03921346
NCT03921346N/ACompleted
CompareCT.gov

A Mobile Device App to Reduce Prehospital Medication Errors and Time to Drug Preparation and Delivery by EMS During Simulated Pediatric Cardiopulmonary Resuscitation: a Multicenter, Prospective, Randomized, Controlled Trial

Pediatric Clinical Research Platform·interventional·Posted Apr 19, 2019·Updated Oct 3, 2024

In Brief

A clinical study evaluating Mobile device app (PedAMINES™) 1st drug, Mobile device app (PedAMINES™) 2nd drug, and 6 other interventions for Cardiopulmonary Arrest and 4 related conditions. Completed, enrolled 150 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiopulmonary Arrest, Resuscitation, Pediatrics, Medication Errors, Emergency Medical Services
CountriesSwitzerland
CollaboratorsUniversity Hospital, Geneva, University of Lausanne Hospitals, Schutz & Rettung Sanitat, Salva Servizio Ambulanza Locarnese e Valli, Fribourg Emergency Medical Services, Fribourg, Switzerland, Réseau Hospitalier Neuchâtelois, Morges & Aubonne Emergency Medical Services (CSUMA), Morges and Aubonne, Switzerland

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedApr 19, 2019
Enrollment StartSep 3, 2019
Primary CompletionJan 31, 2020
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 7.2 years ago

Interventions

Mobile device app (PedAMINES™) 1st drugdevice

To prepare 0.01 mg/kg epinephrine (0.1 mL/kg of 0.1 mg/mL concentration)

Mobile device app (PedAMINES™) 2nd drugdevice

To prepare 0.1 mg/kg midazolam (of 5 mg/mL concentration ad 10 mL sodium chloride 0.9%)

Mobile device app (PedAMINES™) 3rd drugdevice

To prepare 4 mL/kg dextrose 10%

Mobile device app (PedAMINES™) 4th drugdevice

To prepare 1 mmol/kg sodium bicarbonate (of 4.2% = 0.5 mmol/L concentration)

Conventional method 1st drugdevice

To prepare 0.01 mg/kg epinephrine (0.1 mL/kg of 0.1 mg/mL concentration)

Conventional method 2nd drugdevice

To prepare 0.1 mg/kg midazolam (of 5 mg/mL concentration ad 10 mL sodium chloride 0.9%)

Conventional method 3rd drugdevice

To prepare 4 mL/kg dextrose 10%

Conventional method 4th drugdevice

To prepare 1 mmol/kg sodium bicarbonate (of 4.2% = 0.5 mmol/L concentration)