Caring for Children in Vital Distress

NCT05135988 | Completed

• 1 other identifier: 2021/581
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergencies; Children

Outcome Measures

Primary Outcomes (1)

• Evaluation of the practices of paramedical teams in the care of children in vital distress

  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

  Day 0

Secondary Outcomes (8)

• Evaluation of the EasyPedia software impact on reducing the number of errors

  Month 4

• Evaluation of non-technical skills within a team

  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

• 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 cortisol level

  Month 4

Study Arms (2)

Children in vital distress

Health care givers

Experts in vital distress care Non experts in vital distress care

Eligibility Criteria

• Age: 0 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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
• Part 2 in simulation :
• \- 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)
• Non-consenting doctor or paramedic
• Doctor or paramedic who has worked at night for less than 48 hours
• Care givers under guardianship ou curatorship

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

Besançon University Hospital

Besançon, Not in US/Canada, France

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 26, 2021
• Study Start: January 17, 2022
• Primary Completion: November 27, 2023
• Study Completion: November 27, 2023
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

FR (1)