Caring for Children in Vital Distress: Assessment of Paramedical Uses and Benefits of a Software
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Evaluation of the practices of paramedical teams in the care of children in vital distress
Overview
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.
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
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 0 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
- Evaluation of the EasyPedia software impact on reducing the number of errors(Month 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(Month 4)
- Evaluation of the EasyPedia software impact on the stress of the medical team members during a simulated critical situation measured with heart rate(Month 4)
- Evaluation of non-technical skills within a team(Month 4)
- Evaluation of the EasyPedia software impact on the stress of the medical team members during a simulated critical situation measured with cortisol level(Month 4)
- Evaluation of the medical team member self-efficacy during a simulated critical situation(Month 4)
- Evaluation of the EasyPedia software usability(Month 4)
- Evaluation of the EasyPedia software impact on the anxiety of the medical team members during a simulated critical situation measured with visual analogue scale(Month 4)