Efficacy of Simulation-based Neonatal Echocardiography Training (SimuEchoNeo)
- Conditions
- Simulation-based Training on Residents
- Interventions
- Diagnostic Test: TTE simulation-based medical training
- Registration Number
- NCT06442683
- Lead Sponsor
- University Hospital, Caen
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- 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)
- Residents who had already received a TTE training (cardiology or cardiopediatrics 6-month residency or postgraduate training in cardiology or echocardiography)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Simulation group TTE simulation-based medical training Theorical training, simulation-based training and bedside training
- Primary Outcome Measures
Name Time Method Transthoracic echocardiography (TTE) score at 3 months 3 to 4 months after initial training Difference in TTE score at 3 months between the two groups
- Secondary Outcome Measures
Name Time Method TTE score at 6 months 6 months after initial training Difference in TTE score at 6 months between the two groups
Satisfaction score at 6 months 6 months Satisfaction score over 25 points
TTE duration 3-4 months and 6 months TTE duration at 3 and 6 months
Trial Locations
- Locations (3)
University Hospital of Caen
🇫🇷Caen, France
University Hospital of Rouen
🇫🇷Rouen, France
University Hospital of Tours
🇫🇷Tours, France