EmergenciesEasyPediaNCT05135988
Caring for Children in Vital Distress
An observational study of Emergencies and Children, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 15 years
- Conditions the study is for
- Emergencies, Children
- How many people
- 78 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jan 2022to 27 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 15 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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
- 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)
Who cannot join
- 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 :
- Non-consenting doctor or paramedic
- Doctor or paramedic who has worked at night for less than 48 hours
- Care givers under guardianship ou curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Caring for Children in Vital Distress: Assessment of Paramedical Uses and Benefits of a Software
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.
Read the 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
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children in vital distress | Not described | |
| Health care givers | Experts in vital distress care Non experts in vital distress care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0
Secondary outcomes (8)
Evaluation of the EasyPedia software impact on reducing the number of errors
Quantification of error-reduction numbers using EasyPedia in high-fidelity simulation, in part 2 of the study
Measured: Month 4
Evaluation of non-technical skills within a team
Evaluation of non-technical skills within a team (communication, coordination, TEAM-score…) in part 2 of the study
Measured: 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
Evaluation of the medical team member's anxiety in part 2 of the study using a visual analogue scale [VAS] ranging from 0 (not anxious at all) to 10 (very anxious), before and after the simulation session.
Measured: 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
Evaluation of the medical team member's anxiety in part 2 of the study using the Strate Trait Anxiety Inventory (STAI Y1/Y2) ranging from 20 (low anxiety) to 80 (high anxiety) for each form, before and after the simulation session.
Measured: 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
Evaluation of the medical team member's stress in part 2 of the study using measurement of salivary cortisol levels (in nM/L), before and after (juste after and 15 min later) the simulation session.
Measured: 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
Evaluation of the medical team member's stress in part 2 of the study using measurement of heart rate variability using a heart rate monitor belt throughout the simulation session.
Measured: Month 4
Evaluation of the medical team member self-efficacy during a simulated critical situation
Evaluation of self-efficacy perception after the session using a visual analogue scale [VAS] ranging from 0 (totally unable) to 10 (fully capable), in part 2 of the study
Measured: Month 4
Evaluation of the EasyPedia software usability
Evaluation of the EasyPedia software usability using a User Experience Questionnaire (UEQ) with 6 scales (attractiveness, perspicuity, efficiency, dependability, stimulation, novelty) divided into 26 items, after the simulation session with the software, in part 2 of the study. The range of the scales is between -3 (horribly bad) and +3 (extremely good).
Measured: Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start17 Jan 2022
- Primary completion27 Nov 2023
- Study completion27 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135988
- Sponsor's protocol ID
- 2021/581
- Acronym
- EasyPedia
- Status last verified
- Mar 2024
- First submitted
- 25 Oct 2021
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caring for Children in Vital Distress: Assessment of Paramedical Uses and Benefits of a Software
- ClinicalTrials.gov ID
- NCT05135988
- Acronym / sponsor ID
- EasyPedia / 2021/581
- Conditions
- Emergencies, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 26 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children in vital distress | – | – |
| Health care givers | – | –Experts in vital distress care Non experts in vital distress care |
Who may qualify
- Ages
- 0 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (3 listed)
- 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
- 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)
Key exclusion criteria (6 listed)
- 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
- Non-consenting doctor or paramedic
- Doctor or paramedic who has worked at night for less than 48 hours
- Care givers under guardianship ou curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
8 secondary outcomes
Evaluation of the EasyPedia software impact on reducing the number of errors
Time frame: Month 4
Evaluation of non-technical skills within a team
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Month 4
Evaluation of the medical team member self-efficacy during a simulated critical situation
Time frame: Month 4
Evaluation of the EasyPedia software usability
Time frame: Month 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergencies and Children, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the practices of paramedical teams in the care of children in vital distress (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.