Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06442683
Status:
COMPLETED
Last Update Posted:
2024-06-04
First Post:
2024-05-27
Brief Title:
Efficacy of Simulation-based Neonatal Echocardiography Training SimuEchoNeo
Sponsor:
University Hospital Caen
Organization:
University Hospital Caen
Study Overview
Official Title:
Efficacy of Simulation-based Neonatal Echocardiography Training a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SimuEchoNeo
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
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 residencynight 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 EchoComNeo 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 EchoComNeo 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 25 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 Peytons 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 EchoComNeo 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 trainings 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
Beyond access to the e-learning the simulation group participated in standardized training using the neonatal simulator EchoComNeo 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 EchoComNeo 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 25 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 Peytons 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 EchoComNeo 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 trainings 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None