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Caring for Children in Vital Distress (EasyPedia)

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ClinicalTrials.gov Identifier: NCT05135988
Recruitment Status : Not yet recruiting
First Posted : November 26, 2021
Last Update Posted : January 3, 2022
Sponsor:
Information provided by (Responsible Party):
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.

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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Other
Time Perspective: Other
Official Title: Caring for Children in Vital Distress: Assessment of Paramedical Uses and Benefits of a Software
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vital Signs

Group/Cohort
Children in vital distress
Health care givers
Experts in vital distress care Non experts in vital distress care



Primary Outcome Measures :
  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 Outcome Measures :
  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 [ Time Frame: Month 4 ]
    Evaluation of the medical team member's anxiety before and after the simulation session using a visual analogue scale [VAS] ranging from 0 (not anxious at all) to 10 (very anxious), in part 2 of the study

  4. 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

  5. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Part 1 : children in vital distress taken in charge in the Besancon University Hospital Part 2 : health care givers from the Besançon University Hospital
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05135988


Contacts
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Contact: Stéphanie Py, PhD +333.81.21.89.93 s1py@chu-besancon.fr

Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT05135988    
Other Study ID Numbers: 2021/581
First Posted: November 26, 2021    Key Record Dates
Last Update Posted: January 3, 2022
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes