Caring for Children in Vital Distress: Assessment of Paramedical Uses and Benefits of a Software
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Evaluation of the practices of paramedical teams in the care of children in vital distress
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 0 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Evaluation of the practices of paramedical teams in the care of children in vital distress
时间窗: 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
次要结局
- 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)