Development and validation of an assessment tool for adult simulated ultrasound-guided fascia iliaca block: a prospective monocentric study.

BACKGROUND: Fascia iliaca block (FIB) is an effective technique for analgesia. While FIB using ultrasound is preferred, there is no current standardised training technique or assessment scale. We aimed to create a valid and reliable tool to assess ultrasound-guided FIB. METHOD: This prospective observational study was conducted in the ABS-Lab simulation centre, University of Poitiers, France between 26-29 October and 14-17 December 2021. Psychometric testing included validity analysis and reliability between two independent observers. Content validity was established using the Delphi method. Three rounds of feedback were required to reach consensus. To validate the scale, 26 residents and 24 emergency physicians performed a simulated FIB on SIMLIFE, a simulator using a pulsated, revascularised and reventilated cadaver. Validity was tested using Cronbach's α coefficient for internal consistency. Comparative and Spearman's correlation analysis was performed to determine whether the scale discriminated by learner experience with FIB and professional status. Reliability was analysed using the intraclass correlation (ICC) coefficient and a correlation score using linear regression (R2). RESULTS: The final 30-item scale had 8 parts scoring 30 points: patient positioning, preparation of aseptic and tools, anatomical and ultrasound identification, local anaesthesia, needle insertion, injection, final ultrasound control and signs of local anaesthetic systemic toxicity. Psychometric characteristics were as follows: Cronbach's α was 0.83, ICC was 0.96 and R2 was 0.91. The performance score was significantly higher for learners with FIB experience compared with those without experience: 26.5 (22.0; 29.0) vs 22.5 (16.0; 26.0), respectively (p=0.02). There was a significant difference between emergency residents' and emergency physicians' scores: 20.5 (17.0; 25.0) vs 27.0 (26.0; 29.0), respectively (p=0.0001). The performance was correlated with clinical experience (Rho=0.858, p<0.0001). CONCLUSION: This assessment scale was found to be valid, reliable and able to identify different levels of experience with ultrasound-guided FIB.

Anatomical Study of the Application of a Galeo-Pericranial Flap in Oral Cavity Defects Reconstruction.

Oral cavity defects occur after resection of lesions limited to the mucosa, alveolar gum, or minimally affecting the bone. Aiming at esthetical and functional improvements of intraoral reconstruction, the possibility of harvesting a new galeo-pericranial free flap was explored. The objective of this study was to assess the technical feasibility of flap harvesting through anatomical dissections and surgical procedure simulations. Ten head and neck specimens were dissected to simulate the surgical technique and evaluate the vascular calibers of temporal and cervical vessels. The procedure was therefore reproduced on a revascularized and ventilated donor cadaver. Anatomical dissections demonstrated that the mean cervical vascular calibers are compatible with superficial temporal ones, proving to be adequate for anastomosis. Perforating branches of the superficial temporal vascularization nourishing the pericranium were identified in all specimens. In conclusion, blood flow presence was recorded after anastomosing superficial temporal and facial vessels in the revascularized donor cadaver, demonstrating both this procedure's technical feasibility and the potential revascularization of the flap and therefore encouraging its potential in vivo application.

Development and validation of a performance assessment checklist for insertion of an intra-uterine device (IUD).

OBJECTIVES: The World Health Organization (WHO) supports increasing the availability and acceptability of long-acting reversible contraception including intra-uterine device (IUD), but its insertion includes certain risks (uterine perforation). The objective was to develop and validate an IUD insertion performance assessment checklist. MATERIAL AND METHODS: This prospective study took place in hospitals and simulation center of the Poitou-Charentes region, France. The checklist content reached consensus among 10 experts solicited by a Delphi method. A modified gynecologic mannequin Zoe (Gaumard®) was used for simulations. Psychometric testing included 30 multi-professional participants for internal consistency and reliability between two independent observers, and 27 residents for assessment of score evolution over time and reliability. Cronbach alpha (CA) and intraclass coefficient (ICC) were used. Progression of performance was carried out using ANOVA for repeated measures. The data collected were used to plot receiver operating characteristic (ROC) curves for the score values and the area under the curve (AUC) was determined. RESULTS: The checklist included 27 items (2 sections, total score = 27). Psychometric testing showed CA = 0.79, ICC = 0.99, and good clinical relevance. The checklist is discriminative, showing a significant increase in performance scores when the simulations were repeated (F = 77.6, p < 0.0001). ROC curve [AUC: 0.792 (95% CI: 0.71-0.89); p < 0.0001] revealed the best score cutoff predictive of 100% sensitivity, i.e., true positive rate or success rate. Performance score was highly correlated to success rate. The cut-off score guaranteeing successful IUD insertion was 22/27. CONCLUSIONS: This coherent and reproducible checklist for IUD insertion provide an objective assessment of the procedure during SBT, with the aim of obtaining a score ≥ 22/27.

Development and Testing of a Hybrid Simulator for Emergent Umbilical Vein Catheter Insertion Simulation Training.

INTRODUCTION: Emergent umbilical venous catheter (eUVC) insertion is the recommended vascular access in neonatal resuscitation. Although the theoretical knowledge can be taught, existing models are either unrealistic (plastic) or train only the steps of the task. This study aimed to develop and test a hybrid simulator for eUVC insertion training that would be realistic, reproducible, easy to build, and inexpensive, thereby facilitating detailed learning of the procedure. METHODS: Development took place in the Poitiers simulation laboratory using a neonatal mannequin into which a real umbilical cord was integrated. In the first phase, pediatric and emergency physicians and residents tested the model. In the second phase, another group of participants tested the hybrid simulator and the same neonatal mannequin associated with an artificial umbilical cord. Participants completed a satisfaction survey. RESULTS: A real umbilical cord connected to an intra-abdominal reservoir containing artificial blood was added to the mannequin, allowing insertion of the eUVC, drawback of blood, and infusion of fluids using the real anatomical structures. The model was easily reproduced and assembled in less than 30 minutes; the cost of construction and use was evaluated at €115. One hundred two participants tested the model, 60 in the first phase and 42 in the second. The success rate was higher in fully trained compared with untrained participants. All were satisfied, 97% found the model realistic, and 78.6% strongly recommended the use of this model. The participants believed that the hybrid simulator allowed better learning and a gain in performance and self-confidence in comparison with the same mannequin with an artificial umbilical cord. CONCLUSIONS: A hybrid simulator was developed for eUVC insertion. Participants were satisfied with this model, which was realistic, reproducible, easy to use, inexpensive, and facilitated an understanding of the anatomy and performance of all steps for successful eUVC insertion.

Effect of real-time feedback device compared to use or non-use of a checklist performance aid on post-training performance and retention of infant cardiopulmonary resuscitation: A randomized simulation-based trial.

INTRODUCTION: This study aims to determine the best method for achieving optimal performance of pediatric cardiopulmonary resuscitation (CPR) during simulation-based training, whether with or without a performance aid. METHODS: In this randomized controlled study, 46 participants performed simulated CPR in pairs on a Resusci Baby QCPR™ mannequin, repeated after four weeks. All participants performed the first simulation without performance aids. For the second simulation, they were randomly assigned to one of three groups with stratification based on status: throughout CPR, Group A (n = 16) was the control group and did not use a performance aid; Group B (n = 16) used the CPR checklist; Group C (n = 14) used real-time visualization of their CPR activity on a feedback device. Overall performance was assessed using the QCPR™. RESULTS: All groups demonstrated improved performance on the second simulation (p < 0.01). Use of the feedback device resulted in better CPR performance than use of the CPR checklist (p = 0.02) or no performance aid (p = 0.04). Additionally, participants thought that the QCPR™ could effectively improve their technical competences. CONCLUSIONS: Performance aid based on continuous feedback is helpful in the learning process. The use of the QCPR™, a real-time feedback device, improved the quality of resuscitation during infant CPR simulation-based training.

Impact of a Multidisciplinary Simulation-Based Training Program on the Multiple Techniques of Intraosseous Access: A Prospective Multicentric Study.

OBJECTIVES: The aim of this study was to assess intraosseous (IO) access placement performance during a multidisciplinary simulation-based training (SBT) program according to the professional status, experience of caregivers, and the setting of the course. METHOD: This prospective, multicentric study included emergency physicians, residents, certified registered nurse anesthetists, registered nurses, and students. It was carried out between April 6, 2020 and April 30, 2021 in emergency medical services, an emergency department, and a simulation center. Trainee performance was evaluated by 2 independent observers using a validated scale, before and after SBT. Self-assessment of satisfaction was carried out. Interobserver reproducibility was analyzed by intraclass correlation coefficient. The continuous variables were compared using a Student t test or a nonparametric Mann-Whitney U test. Comparative analysis between the different groups used analysis of variance. Correlation analysis was performed by a nonparametric Spearman test. A P value of 0.05 was considered significant. RESULTS: Ninety-eight participants were included. Intraclass correlation coefficient between the 2 observers was 0.96. Performance significantly increased after training, regardless of the site or device used (for the semiautomatic device, P = 0.004 in tibia and P = 0.001 in humeral; for the manual device, P < 0.001). Simulation-based training significantly reduced time for IO access (P = 0.02). After SBT, no difference was found according to professional status and the setting of the course. Performance was not correlated with professional experience. All trainees were satisfied with the training. CONCLUSIONS: Simulation-based training improved the IO access using a semiautomatic or a manual device, regardless of the experience or status of the trainees. Simulation-based training would work for many disciplines regardless of locations (simulation or clinical facilities).

Toward Optimal Learning of the Gesture in Laparoscopic Surgery: Methodology and Performance.

Classical surgical education has to face both a forensic reality and a technical issue: to train a learner in more complex techniques in an increasingly short time. Moreover, surgical training is still based on an empirical hierarchical relationship in which learners must reproduce a sequence of actions in a situation of strong emotional pressure. However, the effectiveness of learning and its quality are linked to the emotional states in which learners find themselves. Among these emotions, epistemic confusion can be found that arises in complex learning situations where there is a cognitive imbalance related to the comprehension of the task, and which results from a rupture between the pre-established patterns of the learner and the new learning task. Although one knows that confusion can have a beneficial or a negative impact on learning, depending on whether it is well regulated or not, the factors that can influence it positively are still poorly understood. Thus, the objective of this experiment is to assess the impact of confusion on the learning of a surgical procedure in an augmented reality context and to determine if this impact varies according to the feedback given to the learners and according to the occurrence of disruptive events. Medical externs were recruited (N = 15) who were required to perform a suturing task on a simulator and whose performance was measured using a Motion Capture (MoCap) system. Even though the statistical analyzes did not allow a conclusion to be reached, the protocol already established makes it possible to consider a longer-term study that will allow (by increasing the number of sessions and the number of participants) more significant results to be obtained in order to develop new surgical learning protocols. This preliminary study opens a new field of research on the influence of epistemic emotions, and more particularly of confusion, which is likely to upset traditional surgical teaching, and is based on negative conditioning and strong emotions with negative valence as well as stress and coercion.

Development of a Performance Assessment Scale for Simulated Dispatcher-Assisted Cardiopulmonary Resuscitation (Telephone-CPR): A Multi-Center Randomized Simulation-Based Clinical Trial.

INTRODUCTION: Dispatchers should be trained to interrogate bystanders with strict protocols to elicit information focused on recognizing cardiac arrest and should provide telephone cardiopulmonary resuscitation (CPR) instructions in all cases of suspected cardiac arrest. While an objective assessment of training outcomes is needed, there is no performance assessment scale for simulated dispatcher-assisted CPR. STUDY OBJECTIVE: The aim of the study was to create a valid and reliable performance assessment scale for simulated dispatcher-assisted CPR. METHODS: In this prospective, randomized, controlled, multi-centric simulation-based trial (registration number TCTR20210130002), the scale was developed according to the European Resuscitation Council (ERC) and American Heart Association (AHA) Guidelines 2015 and revised by experts. The performance of 48 dispatchers' telephone-CPR and of 48 bystanders carrying out CPR on a manikin was assessed by two independent evaluators using the scale and using a SkillReporter (PC) software to provide CPR objective performance. Continuous variables were described as mean (SD) and categorical variables as numbers and percentage (%). Comparative analysis between two groups used a Student t-test or a non-parametric test of Mann-Whitney. The internal structure of the scale was evaluated, including internal consistency using α Cronbach coefficient, and reproducibility using intraclass correlation coefficient (ICC) and linear correlation coefficient (R2) calculation. RESULTS: The scale included three different parts: two sections for dispatchers' (32 items) and bystanders' CPR performance (15 items) assessment, and a third part recording times. There was excellent internal consistency (α Cronbach coefficient = 0.77) and reproducibility (ICC = 0.93; R² = 0.86). For dispatchers' performance assessment, α Cronbach coefficient = 0.76; ICC = 0.91; R2 = 0.84. For bystanders' performance assessment, α Cronbach coefficient = 0.75; ICC = 0.93; R2 = 0.87. Reproducibility was excellent for nine items, good for 19 items, and moderate for 19 items. No item had poor reproducibility. There was no significant difference between dispatch doctors' and medical dispatch assistants' performances (33.0 [SD = 4.7] versus 32.3 [SD = 3.2] out of 52, respectively; P = .70) or between trained and untrained bystanders to follow the instructions (14.3 [SD = 2.0] versus 13.9 [SD = 1.8], respectively; P = .64). Objective performance (%) was significantly higher for trained bystanders than for untrained bystanders (67.4 [SD = 14.5] versus 50.6 [SD = 19.3], respectively; P = .03). CONCLUSION: The scale was valid and reliable to assess performance for simulated dispatcher-assisted CPR. To the authors' knowledge, no other valid performance tool currently exists. It could be used in simulated telephone-CPR training programs to improve performance.

Should we recommend occipital plate fixation using bicortical screws or inverted occipital hooks to optimize occipito-cervical junction fusion? A biomechanical study combining an experimental and analytical approach.

BACKGROUND: Occipito-cervical fusion can be necessary in case of cranio-cervical junction instability. Proximal stabilisation is usually ensured by bi-cortical occipital screws implanted through one median or two lateral occipital plate(s). Bone thickness variability as well as the proximity of vasculo-nervous elements can induce substantial morbidity. The choice of site and implant type remains difficult for surgeons and is often empirically based. Given this challenge, implants with smaller pitch to increase bone interfacing are being developed, as is a surgical technique consisting in inverted occipital hook clamps, a potential alternative to plate/screws association. We present here a biomechanical comparison of the different occipito-cervical fusion devices. METHODS: We have developed a 3D mark tracking technique to measure experimental mechanical data on implants and occipital bone. Biomechanical tests were performed to study the mechanical stiffness of the occipito-cervical instrumentation on human skulls. Four occipital implant systems were analysed: lateral plates+large pitch screws, lateral plates+hooks, lateral plates+small pitch screws and median plate+small pitch screws. Mechanical responses were analysed using 3D displacement field measurements from optical methods and compared with an analytical model. FINDINGS: Paradoxical mechanical responses were observed among the four types of fixations. Lateral plates+small pitch screws appear to show the best accordance of displacement field between bone/implant/system interface providing higher stiffness and an average maximum moment around 50 N.m before fracture. INTERPRETATION: Stability of occipito-cervical fixation depends not only on the site of screws implantation and occipital bone thickness but is also directly influenced by the type of occipital implant.

How tibial tubercle torsion impacts patellar stability: A biomechanics study.

INTRODUCTION: A new factor for patellofemoral instability-external torsion of the tibial tubercle-has recently been described. The primary aim of this biomechanics study was to analyze the consequences of internal torsion tibial tubercle osteotomy (TTO) on an experimentally unstable patella. We hypothesized that internal TTO can stabilize an experimental patellar instability. MATERIALS AND METHODS: This in vitro study was conducted on six fresh anatomical specimens. The knees were flexed to 25°. The patella was destabilized by transecting the patellar retinaculae and the vastus medialis tendon and by applying continuous oblique traction on the quadriceps tendon. A 3D stereovision system was used to record patellar displacement and tilt and to determine whether patellar dislocation occurred. The measurements were done before the osteotomy then repeated on the same knee after a triangular internal torsion 30° TTO was completed, without medialization. RESULTS: There was a significant difference in the patellar displacement and tilt before and after the osteotomy (p<0.05). Patellar dislocation, which was induced by traction on all the knees before osteotomy, did not occur after the osteotomy was performed. DISCUSSION: Internal torsion of the tibial tubercle improves patellar stability, confirming our hypothesis. These findings confirm the stabilizing effect of placing the tibial tuberosity in internal torsion. Although a knee without instability factors is not the perfect model for patellar instability, our findings suggest that tibial tubercle torsion influences patellar stability. Internal TTO may be justified as a surgical treatment of patellofemoral instability.

El efecto de las simulaciones inmersivas repetidas cada 6 semanas en la evolución del rendimiento de un equipo multidisciplinar durante un año: un ensayo controlado aleatorizado en situaciones pediátricas de riesgo vital / Immersive simulation training at 6-week intervals for 1 year and multidisciplinary team performance scores: a randomized controlled trial of simulation training for life-threatening pediatric emergencies

Objetivos. Demostrar el efecto de simulaciones inmersivas repetidas cada 6 semanas, en comparación con su repetición cada 6 meses, sobre la evolución del rendimiento de un equipo multidisciplinar en situaciones pediátricas de riesgo vital durante un año. Método. Ensayo controlado aleatorizado unicéntrico que incluyó 12 equipos multidisciplinares (EMD) del servicio de emergencias médicas (SEM) de Francia compuesto por 4 miembros (médico/residente/enfermera/conductor de ambulancia). En el grupo experimental, 6 EMD se enfrentaron a 9 escenarios diferentes de shock pediátrico en simulaciones de alta fidelidad durante un año. En el grupo de control, 6 EMD tuvieron 3 escenarios comunes a los del grupo experimental (inicial, intermedio -después de seis meses- y final -después de un año-). Se evaluó el rendimiento técnico, mediante la Team Average Performance Assessment Scale (TAPAS) y la escala de rendimiento de acceso intraóseo (IO), y el no técnico, mediante la Clinical Teamwork Scale (CTS) y la Behavioral Assessment Tool (BAT) para los líderes. Se analizó la evolución en el tiempo y se compararon los dos grupos durante los simulacros comunes. Resultados. Las puntuaciones del rendimiento se incrementaron significativamente a lo largo del tiempo en el grupo experimental (p = 0,01 para TAPAS, p = 0,008 para IO, p = 0,03 para CTS y p = 0,02 para BAT) en comparación con el grupo control (p = 0,46 para TAPAS, p = 0,55 para IO, p = 0,62 para CTS y p = 0,58 para BAT). Todas las puntuaciones fueron más altas en el grupo experimental que en el grupo control durante la última sesión (55,8 ± 6,3 vs 31,2 ± 10,3, p = 0,01 para TAPAS; 91,7 ± 8,0 vs 62,9 ± 16,2, p = 0,01 para IO, 63,2 ± 9,3 vs 47,2 ± 13,1, p = 0,03 para CTS; y 72,8 ± 5,1 vs 51,2 ± 14,3, p = 0,01 para BAT). Se observó una diferencia significativa en las dos escalas de puntuación de rendimiento técnico (p = 0,02 para TAPAS y p = 0,03 para IO) a favor del grupo experimental durante la sesión intermedia. También hubo una estrecha relación entre los rendimientos del líder y del equipo, tanto para el rendimiento no técnico (rho > 0,9) como el técnico (rho > 0,7). Conclusiones. La formación basada en la simulación debería repetirse más de tres veces al año. Nuestros resultados favorecen la repetición de una situación poco común de alto riesgo cada seis semanas para mejorar todas las escalas de puntuación de rendimiento y garantizar puntuaciones aceptables de rendimiento técnico y no técnico durante un año

Objective. To demonstrate an effect of 1 year of training using immersive simulations repeated every 6 weeks versus every 6 months to improve the performance of multidisciplinary teams (MDTs) working with children in lifethreatening situations. Methods. Randomized controlled trial in 12 MDTs of emergency responders in France. Each MDT consisted of 4 persons: a physician, a resident, a nurse, and the ambulance driver. Six MDTs participated in 9 different high-fidelity simulations of pediatric shock over the course of a year. Six control MDTs were presented with 3 of the experimental group’s simulations at 3 time points (starting point, 6 months, and 1 year). Technical performance was assessed with the Team Average Performance Assessment Scale (TAPAS) and an intraosseous (IO) access performance scale. Nontechnical performance assessment instruments were the Clinical Teamwork Scale (CTS) and, for leadership, the Behavioral Assessment Tool (BAT). Progress over time was analyzed by comparing the 2 groups during the 3 simulations they experienced in common. Results. Performance scores rose significantly over the study period in the experimental group (P=.01 for the TAPAS score, P=.008 for IO access, P=.03 for the CTS score, and P=.02 for the BAT score) but did not change in the control group (P=.46 for TAPAS, P=.55 for IO access, P=.62 for CTS, and P=.58 for BAT). All mean (SD) scores were higher in the experimental group than in the control group in the last session: TAPAS, 55.8 ± 6.3 vs 31.2 ± 10.3, P=.01; IO access, 91.7 ± 8.0 vs 62.9 ± 16.2, P=.01; CTS, 63.2 ± 9.3 vs 47.2 ± 13.1, P=.03; and BAT, 72.8 ± 5.1 vs 51.2 ± 14.3, P=.01). The 6-month assessment showed significant between-group differences on 2 technical performance measures (P=.02 for TAPAS and P=.03 for IO access); the experimental group’s scores were higher. We also observed close correlations between the performance of the leader and the group on both nontechnical (rho > 0.9) and technical (rho􀀃> 0.7) assessments. Conclusions. Simulation-based training should be repeated more than 3 times per year. Our findings suggest the advisability of repeating simulations of infrequent, high-risk scenarios every 6 weeks to improve all performance scores and guarantee acceptable technical and nontechnical performance throughout the year

Immersive simulation training at 6-week intervals for 1 year and multidisciplinary team performance scores: a randomized controlled trial of simulation training for life-threatening pediatric emergencies. / El efecto de las simulaciones inmersivas repetidas cada 6 semanas en la evolución del rendimiento de un equipo multidisciplinar durante un año: un ensayo controlado aleatorizado en situaciones pediátricas de riesgo vital.

OBJECTIVES: To demonstrate an effect of 1 year of training using immersive simulations repeated every 6 weeks versus every 6 months to improve the performance of multidisciplinary teams (MDTs) working with children in lifethreatening situations. MATERIAL AND METHODS: Randomized controlled trial in 12 MDTs of emergency responders in France. Each MDT consisted of 4 persons: a physician, a resident, a nurse, and the ambulance driver. Six MDTs participated in 9 different high-fidelity simulations of pediatric shock over the course of a year. Six control MDTs were presented with 3 of the experimental group's simulations at 3 time points (starting point, 6 months, and 1 year). Technical performance was assessed with the Team Average Performance Assessment Scale (TAPAS) and an intraosseous (IO) access performance scale. Nontechnical performance assessment instruments were the Clinical Teamwork Scale (CTS) and, for leadership, the Behavioral Assessment Tool (BAT). Progress over time was analyzed by comparing the 2 groups during the 3 simulations they experienced in common. RESULTS: Performance scores rose significantly over the study period in the experimental group (P=.01 for the TAPAS score, P=.008 for IO access, P=.03 for the CTS score, and P=.02 for the BAT score) but did not change in the control group (P=.46 for TAPAS, P=.55 for IO access, P=.62 for CTS, and P=.58 for BAT). All mean (SD) scores were higher in the experimental group than in the control group in the last session: TAPAS, 55.8 ± 6.3 vs 31.2 ± 10.3, P=.01; IO access, 91.7 ± 8.0 vs 62.9 ± 16.2, P=.01; CTS, 63.2 ± 9.3 vs 47.2 ± 13.1, P=.03; and BAT, 72.8 ± 5.1 vs 51.2 ± 14.3, P=.01). The 6-month assessment showed significant between-group differences on 2 technical performance measures (P=.02 for TAPAS and P=.03 for IO access); the experimental group's scores were higher. We also observed close correlations between the performance of the leader and the group on both nontechnical (rho > 0.9) and technical (rho > 0.7) assessments. CONCLUSION: Simulation-based training should be repeated more than 3 times per year. Our findings suggest the advisability of repeating simulations of infrequent, high-risk scenarios every 6 weeks to improve all performance scores and guarantee acceptable technical and nontechnical performance throughout the year.

OBJETIVO: Demostrar el efecto de simulaciones inmersivas repetidas cada 6 semanas, en comparación con su repetición cada 6 meses, sobre la evolución del rendimiento de un equipo multidisciplinar en situaciones pediátricas de riesgo vital durante un año. METODO: Ensayo controlado aleatorizado unicéntrico que incluyó 12 equipos multidisciplinares (EMD) del servicio de emergencias médicas (SEM) de Francia compuesto por 4 miembros (médico/residente/enfermera/conductor de ambulancia). En el grupo experimental, 6 EMD se enfrentaron a 9 escenarios diferentes de shock pediátrico en simulaciones de alta fidelidad durante un año. En el grupo de control, 6 EMD tuvieron 3 escenarios comunes a los del grupo experimental (inicial, intermedio ­después de seis meses­ y final ­después de un año­). Se evaluó el rendimiento técnico, mediante la Team Average Performance Assessment Scale (TAPAS) y la escala de rendimiento de acceso intraóseo (IO), y el no técnico, mediante la Clinical Teamwork Scale (CTS) y la Behavioral Assessment Tool (BAT) para los líderes. Se analizó la evolución en el tiempo y se compararon los dos grupos durante los simulacros comunes. RESULTADOS: Las puntuaciones del rendimiento se incrementaron significativamente a lo largo del tiempo en el grupo experimental (p = 0,01 para TAPAS, p = 0,008 para IO, p = 0,03 para CTS y p = 0,02 para BAT) en comparación con el grupo control (p = 0,46 para TAPAS, p = 0,55 para IO, p = 0,62 para CTS y p = 0,58 para BAT). Todas las puntuaciones fueron más altas en el grupo experimental que en el grupo control durante la última sesión (55,8 ± 6,3 vs 31,2 ± 10,3, p = 0,01 para TAPAS; 91,7 ± 8,0 vs 62,9 ± 16,2, p = 0,01 para IO, 63,2 ± 9,3 vs 47,2 ± 13,1, p = 0,03 para CTS; y 72,8 ± 5,1 vs 51,2 ± 14,3, p = 0,01 para BAT). Se observó una diferencia significativa en las dos escalas de puntuación de rendimiento técnico (p = 0,02 para TAPAS y p = 0,03 para IO) a favor del grupo experimental durante la sesión intermedia. También hubo una estrecha relación entre los rendimientos del líder y del equipo, tanto para el rendimiento no técnico (rho > 0,9) como el técnico (rho > 0,7). CONCLUSIONES: La formación basada en la simulación debería repetirse más de tres veces al año. Nuestros resultados favorecen la repetición de una situación poco común de alto riesgo cada seis semanas para mejorar todas las escalas de puntuación de rendimiento y garantizar puntuaciones aceptables de rendimiento técnico y no técnico durante un año.

Stress response in the daily lives of simulation repeaters. A randomized controlled trial assessing stress evolution over one year of repetitive immersive simulations.

BACKGROUND: Simulations in healthcare reproduce clinical situations in stressful conditions. Repeated stress exposure might influence the learning process in simulation as well as real-life. OBJECTIVES: 1) To record heart rate and heart rate variability evolution during one-day simulation over one year; 2) To analyze the effect of repetitive high-fidelity simulations on the risk of post-traumatic stress disorder. STUDY DESIGN: Single-center, investigator-initiated RCT. 48 participants were randomized in 12 multidisciplinary teams of French Emergency Medical Services to manage infant shock in high-fidelity simulations. In the experimental group, 6 multidisciplinary teams were exposed to 9 different simulation sessions over 1 year. In the control group, 6 multidisciplinary teams participated in only 3 simulation sessions, in common with those of the experimental group (initial, intermediate after 6 months, and finally after 1 year). Heart rate (HR) and heart rate variability (HRV) were analyzed on a 24-hour Holter from the day prior to simulation until the end of simulation. Questionnaires of Impact of Event Scale-Revised at 7 days and Post-traumatic Check-List Scale at 1 month were used to detect possible post-traumatic stress disorder in participants. p<0.05 was considered significant. RESULTS: Stress increased during each simulation in the two groups. After analysis on the 24-hour period, there was no significant difference between the two groups during the initial simulation session in terms of heart rate and heart rate variability. In the 24-hour period of the intermediate and final simulation sessions, the level of stress was higher in the control group during the diurnal (p = 0.04) and nocturnal periods (p = 0.01). No participant developed post-traumatic stress disorder after the 72 simulation sessions. CONCLUSIONS: Despite the stress generated by simulation, the more the sessions were repeated, the less were their repercussions on the daily lives of participants, reflected by a lower sympathetic activity. Moreover, repetition of simulations did not lead to post-traumatic stress disorder. TRIAL REGISTRATION: ClinicalTrials.gov NCT02424890.

Biomechanical analysis of the thoracolumbar spine under physiological loadings: Experimental motion data corridors for validation of finite element models.

Biomechanical studies that involve normal, injured or stabilized human spines are sometimes difficult to perform on large samples due to limited access to cadaveric human spines and biological variability. Finite element models alleviate these limitations due to the possibility of reusing the same model, whereas cadaveric spines can be damaged during testing, or have their mechanicals behaviour modified by fatigue, permanent deformation or structural failure. Finite element models need to be validated with experimental data to make sure that they represent the complex mechanical and physiological behaviour of normal, injured and stabilized spinal segments. The purpose of this study is to characterize the mechanical response of thoracolumbar spine segments with an analytical approach drawn from experimental measurements. A total of 24 normal and fresh cadaveric thoracolumbar spine segments (T11-L3), aged between 53 and 91 years, were tested in pure flexion/extension, lateral bending and axial torsion using a specific experimental setup. Measurements of global and intervertebral angle variations were performed using three-dimensional mark tracking methods. Load/angle curves for each loading were fitted by a logarithmic approach with two coefficients. The coefficients for the functions describing the response of the spinal segments are given and constitute predictive models from experimental data. This work provides data corridors of human thoracolumbar spine motion segments subjected to pure bending in the three physiological planes. These data could be very useful to validate finite element models of the human spine.

Evaluation of stress patterns during simulated laparoscopy in residency.

BACKGROUND: Laparoscopy simulation offers realistic complexity of tasks and required skills, and helps to develop competencies. However the relationship of stress to the experience has not been comprehensively explored. Objectives were: 1) to evaluate stress level before and during laparoscopy in surgery interns (PGY-1) and surgery residents (PGY-2); 2) to evaluate performance in simulated laparoscopy in both groups; 3) to study the correlation between stress pathways themselves and to study which factors mediate the relationship between stress and performance. METHODS: Seven PGY-1 (didactic course plus 2-hour hands-on session) and 6 PGY-2 who usually operate by laparoscopy were included. Performance assessment used the MISTELS scale. Salivary cortisol (SC) was measured the day prior (T0) to simulation, and immediately before (T1), and after the session (T2). Electrophysiological indicators of stress were assessed by Holter: heart rate (HR) and its variability (pNN50) at the same time. Perceived stress was determined at T1. RESULTS: All parameters were similar at T0. Regarding the whole study population, simulation induced stress. However response varied by subgroups. For PGY-1, levels of SC, HR and pNN50 were similar between T0 and T1. Afterwards, SC and HR significantly increased with a parallel decrease in pNN50 at T2. For PGY-2, a significant increase in HR and decrease in pNN50 were observed from T0 to T1, and remained stable at T2. No change in SC level or perceived stress was noted. Performance score was significantly higher in PGY-2. Stress patterns were not correlated between each other but a correlation was found between electrophysiological parameters and performance. CONCLUSIONS: Two stress patterns were identified: PGY-1 exhibited an increase in stress level during the procedure, whereas in PGY-2 it occurred prior to the procedure. This suggests that the impact of simulation on stress parameters might be different according to the experience of the learners.

Randomized controlled trial of multidisciplinary team stress and performance in immersive simulation for management of infant in shock: study protocol.

BACKGROUND: Human error and system failures continue to play a substantial role in adverse outcomes in healthcare. Simulation improves management of patients in critical condition, especially if it is undertaken by a multidisciplinary team. It covers technical skills (technical and therapeutic procedures) and non-technical skills, known as Crisis Resource Management. The relationship between stress and performance is theoretically described by the Yerkes-Dodson law as an inverted U-shaped curve. Performance is very low for a low level of stress and increases with an increased level of stress, up to a point, after which performance decreases and becomes severely impaired. The objectives of this randomized trial are to study the effect of stress on performance and the effect of repeated simulation sessions on performance and stress. METHODS: This study is a single-center, investigator-initiated randomized controlled trial including 48 participants distributed in 12 multidisciplinary teams. Each team is made up of 4 persons: an emergency physician, a resident, a nurse, and an ambulance driver who usually constitute a French Emergency Medical Service team. Six multidisciplinary teams are planning to undergo 9 simulation sessions over 1 year (experimental group), and 6 multidisciplinary teams are planning to undergo 3 simulation sessions over 1 year (control group). Evidence of the existence of stress will be assessed according to 3 criteria: biological, electrophysiological, and psychological stress. The impact of stress on overall team performance, technical procedure and teamwork will be evaluated. Participant self-assessment of the perceived impact of simulations on clinical practice will be collected. Detection of post-traumatic stress disorder will be performed by self-assessment questionnaire on the 7(th) day and after 1 month. DISCUSSION: We will concomitantly evaluate technical and non-technical performance, and the impact of stress on both. This is the first randomized trial studying repetition of simulation sessions and its impact on both clinical performance and stress, which is explored by objective and subjective assessments. We expect that stress decreases team performance and that repeated simulation will increase it. We expect no variation of stress parameters regardless of the level of performance. TRIAL REGISTRATION: ClinicalTrials.gov registration number NCT02424890.

Testing of a Complete Training Model for Chest Tube Insertion in Traumatic Pneumothorax.

INTRODUCTION: Chest tube insertion is a frequent procedure in cases of traumatic pneumothorax, but severe complications can occur if not well performed. Although simulation-based training in chest tube insertion has improved performance, an affordable and realistic model for surgical insertion of a chest tube is lacking. OBJECTIVE: The objective was to design a model for surgical chest tube insertion that would be realistic, affordable, and transportable and that would reflect all extrathoracic and intrathoracic steps of the procedure. METHODS: The model was a task trainer designed by 4 experts in our simulation laboratory combining plastic, electronic, and biologic material. The cost of supplies needed for construction was evaluated. The model was used and tested over 30 months on 56 participants, of whom 44 were surveyed regarding the realism of the model. RESULTS: The model involved a half chest wall (lamb) on a plastic box, connected to a webcam facilitating assessment of the extrathoracic and intrathoracic steps of the procedure, for a cost of €60. Chest tubes, water seal package, and sterile instruments costed €200. All anatomic structures were represented during surgical insertion of chest tube. The demonstration contributed to teaching small groups of up to 8 participants and was reproducible over 30 months of diversely located courses. Anatomic correlation, realism, and learning experience were highly rated by users. CONCLUSIONS: This model for surgical chest tube insertion in traumatic pneumothorax was found to be realistic, affordable, and transportable. Furthermore, it allowed comprehensive assessment of the extrathoracic and intrathoracic procedural steps.

Reliability and validity of a new measurement of lumbar foraminal volume using a computed tomography.

PURPOSE: Measuring foraminal stenosis is generally determined by an area calculation. It is difficult to know exactly where it is most appropriate to measure. No precise data are available on a method for calculating the foraminal volume using a CT. To develop a new method for measuring lumbar foraminal volume, we analyzed repeatability and reliability for measuring methods for foraminal volume using CT. METHODS: The measurements were performed using a CT scan from ten healthy patients, with a mean age of 26.3 years. L3-L4, L4-L5 and L5-S1 foramen were studied, to obtain 60 foraminal measurements. Inter- and intra-observer reproducibility was calculated. Each series was analyzed using the VitreaCore® reconstruction software for volume calculation. RESULTS: Average volume measurements of 60 foramina and 20 L4-L5 foramina were, respectively, 1.17 and 1.25 mm(3) for observer 1 and 1.21 and 1.29 for observer 2. The intra-observer correlation coefficients for observer 1 when measuring all foramina and L4-L5 foramina were 0.98 and 0.99, respectively. For observer 2, coefficients were 0.90 and 0.92, respectively. The inter-observer correlation coefficients for observer 1 when measuring all foramina and L4-L5 foramina were 0.78 and 0.83, respectively. For observer 2, coefficients were 0.77 and 0.8, respectively. The average differences in intra- and inter-observer measurements regardless of the evaluator group were less than 0.2 mm(3). CONCLUSIONS: This is the first study measuring lumbar foraminal volume using CT. The excellent reproducibility of this simple measure can supplement a range of foramen measurement tools.

Intervertebral foramen variation following dynamic L4-L5 interspinal device implantation: foramen size after interspinal device implantation.

STUDY DESIGN: This is a biomechanical study. OBJECTIVE: Measuring changes in foraminal size after L4-L5 interspinous devices implantation. SUMMARY OF BACKGROUND DATA: Low-back pain aetiologies include foraminal stenoses. A niche is developing for interspinal implants that are minimally invasive with few harmful side effects. At present, we do not have sufficient understanding about their impact on the foraminal opening. METHODS: Six fresh L2-S1 columns were prepared with preservation of the capsuloligamentary and discal structures. The L4-L5 foramen was particularly carefully prepared. A 2-dimensional photographic analysis measured the length and width of the foramen and the extraforaminal surface, both before and after the implantation of a supple interspinal device that preserves the supraspinal ligaments. Photographic calibration and the use of precise and identical photographic landmarks (pixels) permitted the calculation of the foraminal deformity. A Wilcoxon test was performed for statistical analysis with P<0.05 for significance. RESULTS: The average foraminal length was 15.7±2.8 mm and the average width was 9.4±1.2 mm. After the implantation of an interspinal device, it was 16.8±2.5 and 10.1±1.3 mm, respectively. The increase in the average foraminal opening was 7.45% and 7.63%, respectively (P=0.02). The average foraminal surface area was 150.4±35.8 mm and following intervention, this was 165.1±28.3 mm, that is an average gain of 14.65 mm (5.3-26.9) (P=0.03). CONCLUSIONS: Few interspinal devices have been the subject of studies on the foraminal opening after implantation. Among the initial strict indications on root compressions for which conventional surgery is too invasive, these implants could present a true therapeutic alternative. This supple implant significantly opened the L4-L5 foramen on the cadavers. Nevertheless, biomechanical data are lacking on its effects on the 3 planes following stress. Even if the impact on the foraminal opening is of interest, kinematic studies are needed to determine the exact effects before clinical implantation.

Estimation of the risk factors for falls in the elderly: can meta-analysis provide a valid answer?

The objective of this study was to analyze whether a meta-analysis could allow us to draw useful conclusions about the risk factors for falls in the elderly. A systematic review was carried out of various databases and completed manually. To satisfy the inclusion criteria, an article had to examine a population of subjects aged over 60 years to pertain to falls occurring during daily living activities, and to involve observational or interventional studies. This review identified 4405 indexed articles published between 1981 and 2011. Of the 220 studies with available data that were included in the final study, just 4% were interventional. Among these 220 studies, just 45% offered a satisfactory level of scientific proof. In total, 88 meta-analyses were carried out on the 156 potential protectors or risk factors that were identified. Our systematic review and meta-analyses ensured that high-quality results were obtained from this comprehensive literature search and included a detailed assessment of the quality of the included studies. Several factors appeared to be disproportionately represented in the literature, a fact that likely reflects the objective and precise assessment of these factors rather than their importance in the falls of the elderly. Thus, we cannot be certain that we obtained the most comprehensive analysis of the risk factors for falling with this method. Meta-analyses can help to define the association between falls and various risk factors, but they have to be used complementary to systematic review for the assessment of risk factors.