Clinical trial NCT05135988: Caring for Children in Vital Distress
Official title: Caring for Children in Vital Distress: Assessment of Paramedical Uses and Benefits of a Software
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergencies
Children
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2021-11-26
Enrollment: 78
Sex: ALL
Minimum age (years): 0
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: 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

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.

Eligibility 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

Primary outcomes:
measure: Evaluation of the practices of paramedical teams in the care of children in vital distress
timeFrame: Day 0
Secondary outcomes:
measure: Evaluation of the EasyPedia software impact on reducing the number of errors
timeFrame: Month 4
measure: Evaluation of non-technical skills within a team
timeFrame: Month 4
measure: Evaluation of the EasyPedia software impact on the anxiety of the medical team members during a simulated critical situation measured with visual analogue scale
timeFrame: Month 4
measure: 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
timeFrame: Month 4
measure: Evaluation of the EasyPedia software impact on the stress of the medical team members during a simulated critical situation measured with cortisol level
timeFrame: Month 4
measure: Evaluation of the EasyPedia software impact on the stress of the medical team members during a simulated critical situation measured with heart rate
timeFrame: Month 4
measure: Evaluation of the medical team member self-efficacy during a simulated critical situation
timeFrame: Month 4
measure: Evaluation of the EasyPedia software usability
timeFrame: Month 4
Other outcomes:
Locations:
city: Besançon
country: France
facility: Besançon University Hospital
state: Not In US/Canada
Study officials:
References: