Clinical Trials Logo

Clinical Trial Summary

There is currently no universally accepted, comprehensive, or standard systematic way to teach the epidural block. Typical teaching of epidural catheter placement consists of a combination of didactic education and hands-on experience, where apprentice and master approached the task together in the clinical setting, with live patients as the learning model. The learning curve is one of the most common tools to assess how the physician in training is progressing at a skill, and it is defined as a curve generated by plotting the success or failure against the number of attempts. More complex learning curves using an acceptable and unacceptable failure rate can be constructed. To perform these more complex learning curves a statistical tool such as the Cumulative Sum Technique (CUSUM) may be used. The CompuFlo Epidural Trainer can differentiate tissue types by pressure signatures that are imperceptible to touch. This allows the trainee to accurately identify the needle location and discriminate between false and true loss of resistance. Having displayed, recorded and printed a graph illustrating the procedure, may also lead to a greater appreciation of the anatomy of the structures the needle must pass. Eye-tracking is the process of measuring either the point of gaze or the motion of an eye relative to the head. This method has been successfully used for proficiency assessment. The aim of this study will be to investigate whether the use of a Structured Didactic Model (SDM) including standardized video lessons, construction of a 3D epidural module, practical training by using an epidural simulator with CompuFlo Trainer instrument, eye tracking assisted technique, may affect the CUSUM learning curve for lumbar epidural block in novice, inexperienced trainees and their eye-tracking patterns.


Clinical Trial Description

Researchers will enroll 15 PGY3 trainees who have never performed an epidural block and are about to begin their obstetrics rotation. After having had the usual standard front-lecture on anatomy and technique, they will be randomized into two groups to receive (study group) or to not receive (control group) the additional SDM (Structured Didactic Model). The additional SDM will consist in two standardized video lessons (anatomy and technique), construction of a 3D epidural plastic module, practical training by using an epidural simulator with the CompuFlo Trainer instrument, and practical training with the eye-tracking assisted technique. After the randomization and before their practice on the patients, all the trainees will undergo eye-tracking measurement of their visual patterns while performing the epidural block on an epidural simulator. All trainees will perform lumbar epidural anesthesia under the supervision of their instructors in accordance with local Institutional policy and practice, with the standard routine equipment and monitoring. Every time the trainee will perform an epidural technique, the number of attempts, needle redirections, and effectiveness of the epidural block will be noted and used to construct the corresponding CUSUM curve. When enough epidurals will be performed by each trainee to reach competence according to the CUSUM curve, a post hoc Power Analysis will be carried out to verify the 95% significance level and the 80 % test power. To study and compare the evolution of the success rate in each group a linear regression model will be applied. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04749186
Study type Interventional
Source European e-Learning School in Obstetric Anesthesia
Contact
Status Enrolling by invitation
Phase N/A
Start date April 7, 2021
Completion date September 30, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT06061003 - 3D Resin Printed Fracture Models for Anatomy Education N/A
Recruiting NCT05483335 - Assessing Burnout in Medical Students in Clerkship Years in United Arab Emirates
Completed NCT04027933 - Standard Patient Simulation in Nursing Students' Approach Toward Patients With Bipolar Disorder N/A
Completed NCT04578821 - Social Justice Advocacy Skills and Ethical Sensitivity N/A
Not yet recruiting NCT03235895 - Evaluation of Internet-Based CME for Wet-cupping Providers N/A
Recruiting NCT04627376 - Multimodal Program for Cancer Related Cachexia Prevention N/A
Active, not recruiting NCT05026619 - Youth Outlook on Life Opportunities Study N/A
Completed NCT04007679 - Pain Neuroscience Education In Students N/A
Completed NCT03154372 - Deliberate Practice With Validated Metrics Improves Skills Acquisition N/A
Completed NCT05208151 - Creative Drama in Physiotherapy and Rehabilitation Education N/A
Completed NCT04042246 - Effect of Knowledge on Vaccine Take-up in Adamawa State, Northeastern Nigeria N/A
Completed NCT06104813 - Evaluation of Deaf Men's Knowledge About Sexual Health
Not yet recruiting NCT03992235 - Importance of Exercise Educational Materials in Chest Physiotherapy N/A
Completed NCT06220708 - Effects Of Dance Movement Therapy On Compassionate Flow In Nursing Students N/A
Completed NCT05010213 - Plaster Patient Education With Roy Adaptation Model N/A
Completed NCT05467969 - Teleteaching on Clinical Procedural Skills
Completed NCT04507048 - Passive Versus Active Educational Interventions for Melanoma Recognition N/A
Withdrawn NCT03360357 - Laparoscopic Vaginal Cuff Suturing Profienciency for OBGYN Residents N/A
Enrolling by invitation NCT03847831 - Feasibility Study of the Pilot Post-primary Active School Flag (PPASF) Program N/A
Not yet recruiting NCT03577340 - Development and Validation of Performance Metrics for Cardiac Device Implant Procedures