Reducing Medication Errors and Time to Drugs Delivery During Pediatric Cardiopulmonary Resuscitation: a Multicenter RCT

NCT03021122 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2018-01-30

No results posted yet for this study

Summary

The investigators recruit nurses working in 5 swiss Pediatric Emergency Departments or divisions to prepare continuous infusions of vasoactive drugs during a simulation-based pediatric CPR cardiac arrest scenario. According to randomization, nurses will have to prepare and deliver vasoactive drugs following their current conventional methods or by the aim of a mobile tablet application called PedAMINES™. PedAMINES™ is designed to support them step-by-step from order to delivery of these drugs.

1. Primary outcome will be to measure in each allocation group the number of medication dosage errors committed during each drug preparation sequence until injection.
2. Secondary outcome will be to measure the time to drug preparation (TDP) and time to drug delivery (TDD).

Conditions

  • Resuscitation
  • Pediatrics

Interventions

DEVICE

PedAMINES™ / Conventional Method

Each nurse will be asked to prepare a 5 μg/kg/min continuous infusion of dopamine (Period 1) and then to prepare a 0.1 μg/kg/min continuous infusion of norepinephrine (Period 2) for a 25kg boy using the studied delivery devices according to the sequence randomly assigned based on a cross-over design: • PedAMINES™ (Period 1) and then Conventional Method (Period 2)

DEVICE

Conventional Method / PedAMINES™

Each nurse will be asked to prepare a 5 μg/kg/min continuous infusion of dopamine (Period 1) and then to prepare a 0.1 μg/kg/min continuous infusion of norepinephrine (Period 2) for a 25kg boy using the studied delivery devices according to the sequence randomly assigned based on a cross-over design: • Conventional Method (Period 1) and then PedAMINES™ (Period 2)

Sponsors & Collaborators

  • University of Geneva, Switzerland

    collaborator OTHER
  • University of Lausanne Hospitals

    collaborator OTHER
  • Insel Gruppe AG, University Hospital Bern

    collaborator OTHER
  • Neuchâtel Hospital, Neuchâtel, Switzerland

    collaborator UNKNOWN
  • Fribourg Hospital, Fribourg, Switzerland

    collaborator UNKNOWN
  • Sion Hospital, Sion, Switzerland

    collaborator UNKNOWN
  • Pediatric Clinical Research Platform

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03021122 on ClinicalTrials.gov