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Efficacy of Simulation-based Neonatal Echocardiography Training (SimuEchoNeo)

Efficacy of Simulation-based Neonatal Echocardiography Training: a Randomized Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06442683
Acronym
SimuEchoNeo
Enrollment
52
Registered
2024-06-04
Start date
2021-05-02
Completion date
2023-10-31
Last updated
2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Simulation-based Training on Residents

Keywords

Neonatology, Simulation-based training, Echocardiography

Brief summary

Echocardiographic examination plays a critical role in neonatology, but its bedside training faces challenges due to limited patient access. While simulation training has proven effective in different fields of adult medical care, its application in neonatal echocardiography remains unexplored. Researchers will compare simulation-based training to usual training (theorical and bedside) for neonatal echocardiography among pediatric residents to see if simulation-trained residents have better skills. Participants will undergo : * theorial, simulation-based and bedside training or * theorical and bedside training only.

Detailed description

All participants were granted full access to the online theorical course throughout the semester of participation, which encompass a presentation of the study and a theorical training. In addition, during their Neonatal Intensive Care Unit (NICU) residency/night shifts, all residents had the possibility to learn bedside transthoracic echocardiography (TTE) and document their experiences using a collection form provided at the time of inclusion. Beyond access to the e-learning, the simulation group participated in standardized training using the neonatal simulator EchoCom\|Neo during the first month of their 6-month residency in NICU. The training session involved a maximum of four residents at the same time, one teacher and one EchoCom\|Neo simulator. The session consisted of the modified Peyton 4-steps process (demonstration, deconstruction, comprehension, performance) with the normal heart scenario set on the simulator, presentation of a persistent ductus arteriosus (PDA), a pericardial effusion case and an evaluation of each resident individually, on the simulator set with normal heart scenario, performing a TTE with a description of the visible structures. The minimum passing score for the validation of the training session was set at 12 out of 14 (reference score, table 1). If the minimum passing score was not achieved, a second training session must have been scheduled until the minimum passing score was reached. The entire simulation session typically lasted between 2.5 to 3 hours. For standardization of training sessions, pre-registered videos were used whenever applicable (presentation of the simulation session, presentation of the simulator, and first and second Peyton's steps), and the training was conducted by the same teacher throughout the study, in the respective hospital of each resident (Caen, Rouen or Tours). Two evaluation timepoints were defined at the middle (3 to 4 months after initial training, M3-M4), and at the end of the 6-month residency (6 months after the training, M6). The evaluation session took place using the EchoCom\|Neo simulator (EchoCom GmbH, Nieheim, Germany), set with the normal heart scenario, and placed on an open neonatal warmer, in the respective hospital of each resident. Each resident was evaluated individually with video recording for second evaluation. Before starting the evaluation, each resident had 5 minutes to familiarize themselves with the handling of the simulator probe. They were asked to perform 7 TTE sections, with the teacher listing each expected TTE section at the beginning of the evaluation. At each evaluation session, two evaluators conducted independent assessments. One evaluator was a pediatric cardiologist, blinded to the randomization, while the other was a pediatric resident (the simulation TTE training's teacher). One evaluator was physically present during the evaluation, while the other used video recording. Each evaluator assigned two scores for each resident: * A reference score: 2 points for each section (optimal, suboptimal, not found), total out of 14 points. * A custom-made score: 1 point for each anatomic structure within each section, emphasizing visualization and recognition of heart structures, total out of 33 points. The duration of the TTE at 3 and 6 months were also recorded with second precision. Following the second evaluation at M6, the number of bedside TTE performed was documented, and a satisfaction questionnaire based on a Likert scale was requested.

Interventions

DIAGNOSTIC_TESTTTE simulation-based medical training

half-day simulation-based neonatal echocardiography training.

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Intervention model description

Multicentered randomized controlled trial.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* residents at all training levels (from first to fifth year) completing a 6-month residency or at least night shifts in neonatology at one of the 3 French NICUs involved (University Hospitals of Caen, Rouen or Tours)

Exclusion criteria

* Residents who had already received a TTE training (cardiology or cardiopediatrics 6-month residency or postgraduate training in cardiology or echocardiography)

Design outcomes

Primary

MeasureTime frameDescription
Transthoracic echocardiography (TTE) score at 3 months3 to 4 months after initial trainingDifference in TTE score at 3 months between the two groups

Secondary

MeasureTime frameDescription
TTE score at 6 months6 months after initial trainingDifference in TTE score at 6 months between the two groups
TTE duration3-4 months and 6 monthsTTE duration at 3 and 6 months
Satisfaction score at 6 months6 monthsSatisfaction score over 25 points

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026