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NCT05135988 | Completed | Emergencies


Caring for Children in Vital Distress
Sponsor:

Centre Hospitalier Universitaire de Besancon

Brief Summary:

Errors during a stressful pediatric critical situation occur more frequently than thought. The main aim of the study is to quantify the number and the type of errors made by pediatric paramedical teams during the management of vital emergencies (medication dosage calculation, compliance with algorithms for management of cardiac arrest…). Then, simulations with and without the EasyPédia software will be compared during a high-fidelity simulation of a standardized pediatric cardiac arrest scenario in order to evaluate its impact on reducing errors during the management of a resuscitation. This study will be a single-center and observational trial in the pediatric intensive care unit of the Besançon University Hospital.

Condition or disease

Emergencies

Children

Detailed Description:

The study is divided in two parts : Part 1 : non-interventional study Part with children in vital distress enrollment. Fifteen patients will be recruited over a period of 1 year in the intensive care unit. Part 2 : high-fidelity simulation tests Part at a simulation platform with assessment of the EasyPedia software. Sixty health care givers divided in 2 groups, experts (intensive care units and specialist mobile emergency units) and non experts (pediatric medicine and pediatric emergencies units) in vital distress care, will be included over a period of 4 months. They will be submitted to two simulation scenarios : with and without the EasyPedia software. The first part follows a case-only observational study model and the second part follows a case-crossover one. Concerning the time perspective, the first part is a cross-sectional study and the second part is prospective.

Study Type : Observational
Estimated Enrollment : 78 participants
Official Title: Caring for Children in Vital Distress: Assessment of Paramedical Uses and Benefits of a Software
Actual Study Start Date : January 17, 2022
Estimated Primary Completion Date : November 27, 2023
Estimated Study Completion Date : November 27, 2023

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 0 Years to 15 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Part 1 in intensive care unit
  • Inclusion Criteria
    • Patients in vital distress taken in charge in intensive care unit : transported by the specialist mobile emergency units, transferred from an other unit of the Besancon University Hospital or from a peripheral hospital on medical decision
    • Children from 0 to 15 years
    Exclusion Criteria
    • Premature newborns and patients transported by the specialist mobile emergency units or transferred from an other unit of the Besancon University Hospital on medical decision not presenting a vital emergency following evaluation of the medical team of the intensive care unit
    • Subject being in the period of exclusion from another study or provided by the national volunteer file
    • Part 2 in simulation
      • Inclusion criteria
      • - Expert teams of doctor and paramedics (10 from pediatric intensive care unit and specialist mobile emergency units) and non expert teams of doctor and paramedics (10 from pediatric medicine and pediatric emergencies units)
      • Exclusion criteria
      • Non-consenting doctor or paramedic
      • Doctor or paramedic who has worked at night for less than 48 hours
      • Care givers under guardianship ou curatorship

Caring for Children in Vital Distress

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Caring for Children in Vital Distress

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Locations


Not yet recruiting

France, Not In US/Canada

Besançon University Hospital

Besançon, Not In US/Canada, France,

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