NCT05135988

Caring for Children in Vital Distress

Caring for Children in Vital Distress: Assessment of Paramedical Uses and Benefits of a Software

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 78 (actual)
• Sponsor: Centre Hospitalier Universitaire de Besancon · Academic / Other
• Sex: All
• Age: 0 Years – 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Emergencies
• Children

Timeline

• Start date: 2022-01-17
• Primary completion: 2023-11-27
• Completion: 2023-11-27
• First posted: 2021-11-26
• Last updated: 2024-03-18

Locations

1 site across 1 country: France