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Completed

NCT Number: NCT05135988

Caring for Children in Vital Distress

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.

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Key information

Conditions

Emergencies Children Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

0 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Besançon University Hospital

Besançon, Not in US/Canada, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Evaluation of the practices of paramedical teams in the care of children in vital distress

    Time frame: Day 0

    Quantification of the number and type of errors made by pediatric paramedical teams during vital emergency management (medication dosage calculation, compliance with algorithms for management of cardiac arrests…), in part 1 of the study

Secondary outcomes

  1. Evaluation of the EasyPedia software impact on reducing the number of errors

    Time frame: Month 4

    Quantification of error-reduction numbers using EasyPedia in high-fidelity simulation, in part 2 of the study

  2. Evaluation of non-technical skills within a team

    Time frame: Month 4

    Evaluation of non-technical skills within a team (communication, coordination, TEAM-score…) in part 2 of the study

  3. Evaluation of the EasyPedia software impact on the anxiety of the medical team members during a simulated critical situation measured with visual analogue scale

    Time frame: Month 4

    Evaluation of the medical team member's anxiety in part 2 of the study using a visual analogue scale [VAS] ranging from 0 (not anxious at all) to 10 (very anxious), before and after the simulation session.

  4. Evaluation of the EasyPedia software impact on the anxiety of the medical team members during a simulated critical situation measured with Strate Trait Anxiety Inventory

    Time frame: Month 4

    Evaluation of the medical team member's anxiety in part 2 of the study using the Strate Trait Anxiety Inventory (STAI Y1/Y2) ranging from 20 (low anxiety) to 80 (high anxiety) for each form, before and after the simulation session.

  5. Evaluation of the EasyPedia software impact on the stress of the medical team members during a simulated critical situation measured with cortisol level

    Time frame: Month 4

    Evaluation of the medical team member's stress in part 2 of the study using measurement of salivary cortisol levels (in nM/L), before and after (juste after and 15 min later) the simulation session.

  6. Evaluation of the EasyPedia software impact on the stress of the medical team members during a simulated critical situation measured with heart rate

    Time frame: Month 4

    Evaluation of the medical team member's stress in part 2 of the study using measurement of heart rate variability using a heart rate monitor belt throughout the simulation session.

  7. Evaluation of the medical team member self-efficacy during a simulated critical situation

    Time frame: Month 4

    Evaluation of self-efficacy perception after the session using a visual analogue scale [VAS] ranging from 0 (totally unable) to 10 (fully capable), in part 2 of the study

  8. Evaluation of the EasyPedia software usability

    Time frame: Month 4

    Evaluation of the EasyPedia software usability using a User Experience Questionnaire (UEQ) with 6 scales (attractiveness, perspicuity, efficiency, dependability, stimulation, novelty) divided into 26 items, after the simulation session with the software, in part 2 of the study. The range of the scales is between -3 (horribly bad) and +3 (extremely good).

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

Caring for Children in Vital Distress: Assessment of Paramedical Uses and Benefits of a Software

Acronym: EasyPedia

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 26, 2021
Registry last updated
Mar 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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