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

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.

Conditions

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

Interventions

DEVICE

Mobile device app (PedAMINES™) 1st drug

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

DEVICE

Mobile device app (PedAMINES™) 2nd drug

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

DEVICE

Mobile device app (PedAMINES™) 3rd drug

To prepare 4 mL/kg dextrose 10%

DEVICE

Mobile device app (PedAMINES™) 4th drug

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

DEVICE

Conventional method 1st drug

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

DEVICE

Conventional method 2nd drug

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

DEVICE

Conventional method 3rd drug

To prepare 4 mL/kg dextrose 10%

DEVICE

Conventional method 4th drug

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

Sponsors & Collaborators

• University Hospital, Geneva

  collaborator OTHER

• University of Lausanne Hospitals

  collaborator OTHER

• Schutz & Rettung Sanitat

  collaborator OTHER

• Salva Servizio Ambulanza Locarnese e Valli

  collaborator OTHER

• Fribourg Emergency Medical Services, Fribourg, Switzerland

  collaborator OTHER

• Réseau Hospitalier Neuchâtelois

  collaborator OTHER

• Morges & Aubonne Emergency Medical Services (CSUMA), Morges and Aubonne, Switzerland

  collaborator OTHER

• Pediatric Clinical Research Platform

  lead OTHER

Principal Investigators

• Johan N Siebert, MD · Geneva Children's Hospital, Geneva University Hospitals, Geneva, Switzerland

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-09-03

Primary Completion

2020-01-31

Completion

2020-01-31

Countries

• Switzerland

Study Locations