Informed consent through 3D virtual reality: a randomized clinical trial.

BACKGROUND: The informed consent is a defining moment that should allow patients to understand their condition, what procedure they are undergoing, and what consequences may follow. This process should foster trust and promote confidence, without increasing patients' anxiety. New immersive 3D imaging technologies may serve as a tool to facilitate this endeavor. METHODS: In a prospective, single-center, randomized controlled clinical trial (SPLICE Study: Surgical Planning and Informed Consent Study; ClinicalTrials.gov NCT03503487), 40 patients undergoing surgery for intracranial tumors were enrolled. After undergoing a traditional surgical informed consent acquisition, 33 patients were randomized 1:1:1 to 3 groups: in 2 experimental groups, patients underwent a 3D, immersive informed consent with two different surgical planners (group 1 and group 2); in the control group, patients underwent an informed consent supported by traditional 2D radiological images. RESULTS: Patients in the experimental groups appreciated this communication experience, while their objective comprehension was higher ((score mean (SD)): group 1 82.65 (6.83); group 2 77.76 (10.19)), as compared with the control group (57.70 (12.49); P < 0.001). Subjective comprehension and anxiety levels did not differ between experimental groups and control group. CONCLUSIONS: 3D virtual reality can help surgeons and patients in building a better relationship before surgery; immersive 3D-supported informed consent improves patients' comprehension of their condition without increasing anxiety. This new paradigm may foster trust between surgeons and patients, possibly restraining medical-legal acts. TRAIL REGISTRATION: ClinicalTrials.gov NCT03503487.

Propofol and sevoflurane affect intra-operative memory formation of words differently: A prospective cohort study.

BACKGROUND: Memory priming seems possible even during apparently adequate anaesthesia. However, the effects of different anaesthetics and type of stimuli, by virtue of their specific neural underpinnings, have not been considered. OBJECTIVE: To determine if intra-operative implicit memory is affected by the type of anaesthesia (propofol or sevoflurane) or by the type of stimuli (abstract or concrete words). DESIGN: Two consecutive, randomised controlled experiments. SETTING: Neurological institute in Milan, Italy. PATIENTS: Forty-three patients undergoing anaesthesia with propofol (experiment 1) and 32 patients undergoing anaesthesia with sevoflurane (experiment 2). Patients were ASA I or II, age 18 to 65 years, native Italian speakers, right-handed and without any condition affecting memory or hearing. INTERVENTION: During anaesthesia, the patients heard a list of either concrete or abstract words or no words at all (controls). Explicit memory was tested with an explicit recall task and the Brice Interview; implicit memory was assessed through a word stem completion test. OUTCOME MEASURES: The number of explicitly recalled words, positivity to the Brice Interview, the proportion of target and nontarget hits, and a derived implicit memory score. RESULTS: With propofol, the proportion of target hits was significantly greater than the proportion of nontarget hits for the concrete word experimental group (P = 0.018). The implicit memory score of the concrete word experimental group was significantly higher than the score of both the abstract word experimental group (P  = 0.000) and the concrete word control group (P = 0.023). With sevoflurane, the proportion of target hits was significantly higher than the proportion of nontarget hits for the abstract word experimental group only (P = 0.027). No patients had a BIS above 60 and no one could recall intra-operative events or words. CONCLUSION: Intra-operative memory for words can form during apparently adequate BIS-guided anaesthesia but is modified by propofol or sevoflurane acting on different brain targets. Further studies on larger samples and using neuroimaging techniques are needed. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT03727464.

Filling the gap between the OR and virtual simulation: a European study on a basic neurosurgical procedure.

BACKGROUND: Currently available simulators are supposed to allow young neurosurgeons to hone their technical skills in a safe environment, without causing any unnecessary harm to their patients caused by their inexperience. For this training method to be largely accepted in neurosurgery, it is necessary to prove simulation efficacy by means of large-scale clinical validation studies. METHODS: We correlated and analysed the performance at a simulator and the actual operative skills of different neurosurgeons (construct validity). We conducted a study involving 92 residents and attending neurosurgeons from different European Centres; each participant had to perform a virtual task, namely the placement of an external ventricular drain (EVD) at a neurosurgical simulator (ImmersiveTouch). The number of attempts needed to reach the ventricles and the accuracy in positioning the catheter were assessed. RESULTS: Data suggests a positive correlation between subjects who placed more EVDs in the previous year and those who get better scores at the simulator (p = .008) (fewer attempts and better surgical accuracy). The number of attempts to reach the ventricle was also analysed; senior residents needed fewer attempts (mean = 2.26; SD = 1.11) than junior residents (mean = 3.12; SD = 1.05) (p = .007) and staff neurosurgeons (mean = 2.89, SD = 1.23). Scoring results were compared by using the Fisher's test, for the analysis of the variances, and the Student's T test. Surprisingly, having a wider surgical experience overall does not correlate with the best performance at the simulator. CONCLUSION: The performance of an EVD placement on a simulator correlates with the density of the neurosurgical experience for that specific task performed in the OR, suggesting that simulators are able to differentiate neurosurgeons according to their surgical ability. Namely this suggests that the simulation performance reflects the surgeons' consistency in placing EVDs in the last year.

Simulation to become a better neurosurgeon. An international prospective controlled trial: The Passion study.

Introduction: Surgical training traditionally adheres to the apprenticeship paradigm, potentially exposing trainees to an increased risk of complications stemming from their limited experience. To mitigate this risk, augmented and virtual reality have been considered, though their effectiveness is difficult to assess. Research question: The PASSION study seeks to investigate the improvement of manual dexterity following intensive training with neurosurgical simulators and to discern how surgeons' psychometric characteristics may influence their learning process and surgical performance. Material and methods: Seventy-two residents were randomized into the simulation group (SG) and control group (CG). The course spanned five days, commencing with assessment of technical skills in basic procedures within a wet-lab setting on day 1. Over the subsequent core days, the SG engaged in simulated procedures, while the CG carried out routine activities in an OR. On day 5, all residents' technical competencies were evaluated. Psychometric measures of all participants were subjected to analysis. Results: The SG demonstrated superior performance (p < 0.0001) in the brain tumour removal compared to the CG. Positive learning curves were evident in the SG across the three days of simulator-based training for all tumour removal tasks (all p-values <0.05). No significant differences were noted in other tasks, and no meaningful correlations were observed between performance and any psychometric parameters. Discussion and conclusion: A brief and intensive training regimen utilizing 3D virtual reality simulators enhances residents' microsurgical proficiency in brain tumour removal models. Simulators emerge as a viable tool to expedite the learning curve of in-training neurosurgeons.

Application of an aviation model of incident reporting and investigation to the neurosurgical scenario: method and preliminary data.

OBJECT: Incident reporting systems are universally recognized as important tools for quality improvement in all complex adaptive systems, including the operating room. Nevertheless, introducing a safety culture among neurosurgeons is a slow process, and few studies are available in the literature regarding the implementation of an incident reporting system within a neurosurgical department. The authors describe the institution of an aviation model of incident reporting and investigation in neurosurgery, focusing on the method they have used and presenting some preliminary results. METHODS: In 2010, the Inpatient Safety On-Board project was developed through cooperation between a team of human factor and safety specialists with aviation backgrounds (DgSky team) and the general manager of the Fondazione Istituto Neurologico Carlo Besta. In 2011, after specific training in safety culture, the authors implemented an aviation-derived prototype of incident reporting within the Department of Neurosurgery. They then developed an experimental protocol to track, analyze, and categorize any near misses that happened in the operating room. This project officially started in January 2012, when a dedicated team of assessors was established. All members of the neurosurgical department were asked to report near misses on a voluntary, confidential, and protected form (Patient Incident Reporting System form, Besta Safety Management Programme). Reports were entered into an online database and analyzed by a dedicated team of assessors with the help of a facilitator, and an aviation-derived root cause analysis was performed. RESULTS: Since January 2012, 14 near misses were analyzed and classified. The near-miss contributing factors were mainly related to human factors (9 of 14 cases), technology (1 of 14 cases), organizational factors (3 of 14 cases), or procedural factors (1 of 14 cases). CONCLUSIONS: Implementing an incident reporting system is quite demanding; the process should involve all of the people who work within the environment under study. Persistence and strong commitment are required to enact the culture change essential in shifting from a paradigm of infallible operators to the philosophy of errare humanum est. For this paradigm shift to be successful, contributions from aviation and human factor experts are critical.

A virtual reality home-based training for the management of stress and anxiety among healthcare workers during the COVID-19 pandemic: study protocol for a randomized controlled trial.

BACKGROUND: Healthcare workers represent one of the most affected categories by the adverse effects of the COVID-19 pandemic on mental health. Excessive stress and anxiety are critical factors that could compromise work performance. Besides, high levels of stress and anxiety may have long-term physical and psychological consequences. Recent studies investigated virtual reality to reduce stress and anxiety among healthcare workers during the COVID-19 pandemic. However, the proposed virtual reality interventions have important limitations related to their location (i.e., research lab and hospitals) and content (i.e., virtual experiences only for relaxation). Within this context, this randomized controlled trial aims to investigate the efficacy and acceptability of a brief home-based virtual reality training for managing stress and anxiety during the COVID-19 crisis in a sample of Italian healthcare workers. METHODS: The study is a randomized controlled trial. It includes two groups of 30 individuals recruited from healthcare workers: (1) the experimental group and (2) the control group. Participants in the experimental group will receive a training consisting of three home sessions performed in a week. In each session, participants will try through an immersive virtual reality standalone system (i.e., Oculus Quest 2) a virtual psychoeducation experience on stress and anxiety (i.e., MIND-VR). Subsequently, they will try the virtual relaxation content (i.e., The Secret Garden). The control group will receive no training and will be reassessed one week and one month after the initial evaluation. DISCUSSION: If the proposed brief home-based virtual reality training will result helpful and easy to use, it could become an empirically assessed viable option for protecting healthcare workers' mental health both during the COVID-19 pandemic and once it will be over. Furthermore, the intervention might be easily adapted for other categories of people who need support in managing stress and anxiety. TRIAL REGISTRATION: ClinicalTrials.gov NCT04611399 .

Effects of direct laryngoscopy versus Glidescope videolaryngoscopy on subjective and objective measures of cognitive workload: an in-vivo randomized trial.

BACKGROUND: Laryngoscopy and tracheal intubation are associated with high operators' workload, which potentially causes lower performance and risk of errors. Measuring anesthesiologists' mental workload during instrumental procedures allows to test the usability of the devices and, by managing operators' workload, improve clinical decision making. The aim of this study was to investigate the differences in subjective and objective cognitive workload between videolaryngoscopy with hyperangulated blade (Glidescope) vs. direct laryngoscopy in a real clinical setting. METHODS: Fourteen anesthesiologists were enrolled and performed three intubations for each device, a Glidescope videolaryngoscope (Verathon Inc., Schiltigheim, France) and a Macintosh (Apple Inc., Cupertino, CA, USA) direct laryngoscope, in a random order. The subjective workload was assessed with the NASA Task Load Index questionnaire right after intubation and reaction times to a secondary task were recorded during laryngoscopy and intubation as an objective measure of workload. RESULTS: The overall perceived workload (P<0.001) and the subscales of physical demand (P<0.001) and effort (P<0.001) were lower during Glidescope than during Macintosh laryngoscopy. Reaction times were faster during Glidescope than during Macintosh laryngoscopy (P<0.014). A significant positive correlation was found between reaction times and the overall perceived workload (P<0.001). CONCLUSIONS: A videolaryngoscope with hyperangluated blade used in a real clinical scenario of elective surgery significantly reduced both subjective and objective workload compared to a direct laryngoscope. Physical demand and effort were the key components in reducing operators' mental workload. Therefore, the expert use of a videolaryngoscope with hyperangulated blade constitutes an ergonomic option that could limit operators' workload and improve patients' safety and operators' well-being.

Analyzing the Loss and the Recovery of Consciousness: Functional Connectivity Patterns and Changes in Heart Rate Variability During Propofol-Induced Anesthesia.

The analysis of the central and the autonomic nervous systems (CNS, ANS) activities during general anesthesia (GA) provides fundamental information for the study of neural processes that support alterations of the consciousness level. In the present pilot study, we analyzed EEG signals and the heart rate (HR) variability (HRV) in a sample of 11 patients undergoing spinal surgery to investigate their CNS and ANS activities during GA obtained with propofol administration. Data were analyzed during different stages of GA: baseline, the first period of anesthetic induction, the period before the loss of consciousness, the first period after propofol discontinuation, and the period before the recovery of consciousness (ROC). In EEG spectral analysis, we found a decrease in posterior alpha and beta power in all cortical areas observed, except the occipital ones, and an increase in delta power, mainly during the induction phase. In EEG connectivity analysis, we found a significant increase of local efficiency index in alpha and delta bands between baseline and loss of consciousness as well as between baseline and ROC in delta band only and a significant reduction of the characteristic path length in alpha band between the baseline and ROC. Moreover, connectivity results showed that in the alpha band there was mainly a progressive increase in the number and in the strength of incoming connections in the frontal region, while in the beta band the parietal region showed mainly a significant increase in the number and in the strength of outcoming connections values. The HRV analysis showed that the induction of anesthesia with propofol was associated with a progressive decrease in complexity and a consequent increase in the regularity indexes and that the anesthetic procedure determined bradycardia which was accompanied by an increase in cardiac sympathetic modulation and a decrease in cardiac parasympathetic modulation during the induction. Overall, the results of this pilot study showed as propofol-induced anesthesia caused modifications on EEG signal, leading to a "rebalance" between long and short-range cortical connections, and had a direct effect on the cardiac system. Our data suggest interesting perspectives for the interactions between the central and autonomic nervous systems for the modulation of the consciousness level.

Motor Evoked Potentials and Bispectral Index-Guided Anaesthesia in Image-Guided Mini-Invasive Neurosurgery of Supratentorial Tumors Nearby the Cortico-Spinal Tract.

AIM: To describe and evaluate the anaesthesiological regimen used in neurophysiologically monitored image-guided mini-invasive neurosurgery. MATERIAL AND METHODS: Twenty-four patients underwent elective surgery under general anaesthesia that was administered through Target Controlled Infusion (TCI) for effect-site concentration (Ce) of Propofol and Remifentanil, targeting the Bispectral Index (BIS) in the 40-60 intervals. The stimulating intensity of transcranial motor evoked potentials (tMEP), BIS, Propofol and Remifentanil Ce were collected at MEPs threshold (T) definition (respectively BIS@T, CeProp@T and CeRemi@T). Intraoperative seizure, explicit recall for intraoperative awareness and clinical motor status were assessed. RESULTS: CeProp@T and CeRemi@T ranged respectively between 1.5-2.2 µg/ml (Median 1.6 µg/ml) and 3.5-18 ng/ml (Median 8 ng/ml) that were effective in keeping the BIS@T between 40 and 60 in all surgeries. tMEP thresholds ranged between 45 and 120 mA. There was no correlation between CeProp@T, CeRemi@T and tMEP, as well as between BIS@T and respectively tMEP, CeProp@T, CeRemi@T. None of patients had induced electrical seizure or explicit recalls. Motor scores were equal to preoperative values in 22/24 patients. CONCLUSION: BIS-guided general anaesthesia within a 40-60 interval, with low Ce of Propofol (≤2 µ/ml) and high analgesic regime allow reliable tMEP measurements, avoiding postoperative neurological impairment and major adverse outcomes, such as seizure and awareness.

The role of anesthesia in the prevention of postoperative delirium: a systematic review.

INTRODUCTION: Postoperative delirium (POD) is defined as an acute neurologic insult characterized by changes in consciousness and cognition, altered perception and a fluctuating course. It leads to poor outcome and increased health care system costs. Considering its high incidence, up to 60%, and the lack of a first-choice treatment, prevention has become a priority. Our aim was to systematically review literature on POD prevention and to identify the role of anesthesia in this context. EVIDENCE ACQUISITION: MEDLINE and EMBASE were searched for studies considering any anesthetic intervention intended to prevent POD. Risk of bias was assessed with the Quality Assessment Tool for Quantitative Studies for original articles and with the R-AMSTAR checklist for systematic reviews. EVIDENCE SYNTHESIS: A total of 27 studies were included. Interventions included pre-, intra-/peri- and postoperative strategies to prevent POD. Only 9 out of 27 studies had high methodological quality. Use of a depth of anesthesia monitor and lighter sedation had the strongest evidence in reduction of POD. Perioperative dexmedetomidine, ketamine, dexamethasone, and antipsychotic administration may reduce the risk of POD. CONCLUSIONS: Methodologically robust studies supporting strategies for preventing POD are still lacking. Based on our analysis, anesthesiologists should consider the intraoperative use of a depth of anesthesia monitor and the choice for a lighter sedation when possible. The administration of preventive medications should be considered very carefully. Considering the multifactorial nature of POD, however, the integration of effective preventive strategies into multidisciplinary programs is advisable and should be the target for future research.

Does the Maslach Burnout Inventory correlate with cognitive performance in anesthesia practitioners? A pilot study.

BACKGROUND: Chronic stress is a common condition among health-care operators, anesthetists in particular. It is known to cause cognitive weakening and pathological outcomes, as the Burnout syndrome. Nevertheless, the impact of clinicians' health on their performance has received limited attention thus far. Our pilot study, aims at evaluating the influence of burnout on the cognitive performance in a population of anesthesia practitioners. METHODS: In 18 practitioners we assessed attention by means of reaction times (RTs), pre- and post-shift, with a five-subtest computerized neuropsychological battery. RTs were controlled for the situational anxiety with the State-Trait Anxiety Inventory X1. The burnout level was evaluated with the Maslach Burnout Inventory (MBI). The three MBI sub-scores (emotional exhaustion, depersonalization and professional achievement) were combined to obtain two groups according to the burnout score (high and low). RESULTS: Anesthetists showed a significantly worse performance in the fifth test post-shift (P=0.041) than pre-shift. The high-score burnout group reacted slower than the low-score burnout group in three of the five cognitive subtests, without reaching a statistical significance. Nevertheless, our effect size, which is independent from the sample size, is very large (d=1.165). CONCLUSION: We found that in a population of health-care operators, burnout may affect the cognitive and potentially, the working performance. Qualitative and quantitative measurements should be integrated to ensure a better management of burnout and its consequences in workplaces.