EasyPedia: Caring for Children in Vital Distress
Study Details
Study Description
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 | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Children in vital distress
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| Health care givers Experts in vital distress care Non experts in vital distress care |
Outcome Measures
Primary Outcome Measures
- Evaluation of the practices of paramedical teams in the care of children in vital distress [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
- Evaluation of the EasyPedia software impact on reducing the number of errors [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 [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 [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 [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 [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).
Eligibility Criteria
Criteria
Part 1 in intensive care unit :
Inclusion Criteria:
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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
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Children from 0 to 15 years
Exclusion Criteria:
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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
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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
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Non-consenting doctor or paramedic
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Doctor or paramedic who has worked at night for less than 48 hours
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Care givers under guardianship ou curatorship
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Besançon University Hospital | Besançon | Not In US/Canada | France |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Besancon
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021/581