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
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|
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 :||75 participants|
|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|
|Children in vital distress|
Health care givers
Experts in vital distress care Non experts in vital distress care
- 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
- 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
- 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
- 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
- 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
- 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).
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
|Contact: Stéphanie Py, PhDfirstname.lastname@example.org|