Evaluation and patient experience of wireless noninvasive fetal heart rate monitoring devices.

INTRODUCTION: In clinical practice, fetal heart rate monitoring is performed intermittently using Doppler ultrasound, typically for 30 minutes. In case of a non-reassuring heart rate pattern, monitoring is usually prolonged. Noninvasive fetal electrocardiography may be more suitable for prolonged monitoring due to improved patient comfort and signal quality. This study evaluates the performance and patient experience of four noninvasive electrocardiography devices to assess candidate devices for prolonged noninvasive fetal heart rate monitoring. MATERIAL AND METHODS: Non-critically sick women with a singleton pregnancy from 24 weeks of gestation were eligible for inclusion. Fetal heart rate monitoring was performed during standard care with a Doppler ultrasound device (Philips Avalon-FM30) alone or with this Doppler ultrasound device simultaneously with one of four noninvasive electrocardiography devices (Nemo Fetal Monitoring System, Philips Avalon-Beltless, Demcon Dipha-16 and Dräger Infinity-M300). Performance was evaluated by: success rate, positive percent agreement, bias, 95% limits of agreement, regression line, root mean square error and visual agreement using FIGO guidelines. Patient experience was captured using a self-made questionnaire. RESULTS: A total of 10 women were included per device. For fetal heart rate, Nemo performed best (success rate: 99.4%, positive percent agreement: 94.2%, root mean square error 5.1 BPM, bias: 0.5 BPM, 95% limits of agreement: -9.7 - 10.7 BPM, regression line: y = -0.1x + 11.1) and the cardiotocography tracings obtained simultaneously by Nemo and Avalon-FM30 received the same FIGO classification. Comparable results were found with the Avalon-Beltless from 36 weeks of gestation, whereas the Dipha-16 and Infinity-M300 performed significantly worse. The Avalon-Beltless, Nemo and Infinity-M300 closely matched the performance of the Avalon-FM30 for maternal heart rate, whereas the performance of the Dipha-16 deviated more. Patient experience scores were higher for the noninvasive electrocardiography devices. CONCLUSIONS: Both Nemo and Avalon-Beltless are suitable devices for (prolonged) noninvasive fetal heart rate monitoring, taking their intended use into account. But outside its intended use limit of 36 weeks' gestation, the Avalon-Beltless performs less well, comparable to the Dipha-16 and Infinity-M300, making them currently unsuitable for (prolonged) noninvasive fetal heart rate monitoring. Noninvasive electrocardiography devices appear to be preferred due to greater comfort and mobility.

Process model analysis of parenchyma sparing laparoscopic liver surgery to recognize surgical steps and predict impact of new technologies.

BACKGROUND: Surgical process model (SPM) analysis is a great means to predict the surgical steps in a procedure as well as to predict the potential impact of new technologies. Especially in complicated and high-volume treatments, such as parenchyma sparing laparoscopic liver resection (LLR), profound process knowledge is essential for enabling improving surgical quality and efficiency. METHODS: Videos of thirteen parenchyma sparing LLR were analyzed to extract the duration and sequence of surgical steps according to the process model. The videos were categorized into three groups, based on the tumor locations. Next, a detailed discrete events simulation model (DESM) of LLR was built, based on the process model and the process data obtained from the endoscopic videos. Furthermore, the impact of using a navigation platform on the total duration of the LLR was studied with the simulation model by assessing three different scenarios: (i) no navigation platform, (ii) conservative positive effect, and (iii) optimistic positive effect. RESULTS: The possible variations of sequences of surgical steps in performing parenchyma sparing depending on the tumor locations were established. The statistically most probable chain of surgical steps was predicted, which could be used to improve parenchyma sparing surgeries. In all three categories (i-iii) the treatment phase covered the major part (~ 40%) of the total procedure duration (bottleneck). The simulation results predict that a navigation platform could decrease the total surgery duration by up to 30%. CONCLUSION: This study showed a DESM based on the analysis of steps during surgical procedures can be used to predict the impact of new technology. SPMs can be used to detect, e.g., the most probable workflow paths which enables predicting next surgical steps, improving surgical training systems, and analyzing surgical performance. Moreover, it provides insight into the points for improvement and bottlenecks in the surgical process.

Real-time laser speckle contrast imaging measurement during normothermic machine perfusion in pretransplant kidney assessment.

OBJECTIVES: Normothermic machine perfusion (NMP) provides a platform for pre-transplant kidney quality assessment that is essential for the use of marginal donor kidneys. Laser speckle contrast imaging (LSCI) presents distinct advantages as a real-time and noncontact imaging technique for measuring microcirculation. In this study, we aimed to assess the value of LSCI in visualizing renal cortical perfusion and investigate the additional value of dual-side LSCI measurements compared to single aspect measurement during NMP. METHODS: Porcine kidneys were obtained from a slaughterhouse and then underwent NMP. LSCI was used to measure one-sided cortical perfusion in the first 100 min of NMP. Thereafter, the inferior renal artery branch was occluded to induce partial ischemia and LSCI measurements on both ventral and dorsal sides were performed. RESULTS: LSCI fluxes correlated linearly with the renal blood flow (R2 = 0.90, p < 0.001). After renal artery branch occlusion, absence of renal cortical perfusion could be visualized and semiquantified by LSCI. The overall ischemic area percentage of the ventral and dorsal sides was comparable (median interquartile range [IQR], 38 [24-43]% vs. 29 [17-46]%, p = 0.43), but heterogenous patterns between the two aspects were observed. There was a significant difference in oxygen consumption (mean ± standard deviation [SD], 2.57 ± 0.63 vs. 1.83 ± 0.49 mLO2 /min/100 g, p < 0.001), urine output (median [IQR], 1.3 [1.1-1.7] vs. 0.8 [0.6-1.3] mL/min, p < 0.05), lactate dehydrogenase (mean ± SD, 768 ± 370 vs. 905 ± 401 U/L, p < 0.05) and AST (mean ± SD, 352 ± 285 vs. 462 ± 383 U/L, p < 0.01) before and after renal artery occlusion, while no significant difference was found in creatinine clearance, fractional excretion of sodium, total sodium reabsorption and histological damage. CONCLUSIONS: LSCI fluxes correlated linearly with renal blood flow during NMP. Renal cortical microcirculation and absent perfusion can be visualized and semiquantified by LSCI. It provides a relative understanding of perfusion levels, allowing for a qualitative comparison between regions in the kidney. Dual-side LSCI measurements are of added value compared to single aspect measurement and renal function markers.

Using Acoustic Vibrations as a Method for Implant Insertion Assessment in Total Hip Arthroplasty.

The success of total hip arthroplasty depends on the experience of the surgeon, and one of the ways the surgeon currently determines the final implant insertion depth is to listen to the change in audible pitch of the hammering sound. We investigated the use of vibration emissions as a novel method for insertion quality assessment. A non-invasive contact microphone-based measurement system for insertion depth estimation, fixation and fracture detection was developed using a simplified in vitro bone/implant (n = 5). A total of 2583 audio recordings were analyzed in vitro to obtain energy spectral density functions. Out of the four main resonant peaks under in vitro conditions, broach insertion depth statistically correlates to increasing 3rd and 4th peak frequencies. Degree of fixation was also observed as higher goodness of fit (0.26-0.78 vs. 0.12-0.51 between two broach sizes, the latter undersized). Finally, however, the moment of fracture could not be predicted. A cadaveric in situ pilot study suggests comparable resonant frequencies in the same order of magnitudes with the bone model. Further understanding of the signal patterns are needed for an early warning system diagnostic system for imminent fractures, bone damage, improving accuracy and quality of future procedures.

Can effective pedagogy be ensured in minimally invasive surgery e-learning?

INTRODUCTION: Effectiveness of e-learning diminishes without the support of a pedagogical model to guide its use. In minimally invasive surgery (MIS), this has been reported as a limitation when technology is used to deliver contents without a sound pedagogical background. MATERIAL AND METHODS: We describe how a generic pedagogical model, the 3D pedagogy framework, can be used for setting learning outcomes and activities in e-learning platforms focused on MIS cognitive skills. A demonstrator course on Nissen fundoplication was developed following the model step-by-step in the MISTELA learning platform. Course design was informed by Kolb's Experiential learning model. Content validation was performed by 13 MIS experts. RESULTS: Ten experts agreed on the suitability of content structuring done according to the pedagogical model. All experts agreed that the course provides means to assess the intended learning outcomes. CONCLUSIONS: This work showcases how a general-purpose e-learning framework can be accommodated to the needs of MIS training without limiting the course designers' pedagogical approach. Key advances for its success include: (1) proving the validity of the model in the wider scope of MIS skills and (2) raising awareness amongst stakeholders on the need of developing training plans with explicit, rather than assumed, pedagogical foundations. Abbreviations: MIS: minimally invasive surgery; TEL: technology enhanced learning.

Proton density fat fraction of the spinal column: an MRI cadaver study.

BACKGROUND: The increased popularity of minimally invasive spinal surgery calls for a revision of guidance techniques to prevent injuries of nearby neural and vascular structures. Lipid content has previously been proposed as a distinguishing criterion for different bone tissues to provide guidance along the interface of cancellous and cortical bone. This study aims to investigate how fat is distributed throughout the spinal column to confirm or refute the suitability of lipid content for guidance purposes. RESULTS: Proton density fat fraction (PDFF) was assessed over all vertebral levels for six human cadavers between 53 and 92 years of age, based on fat and water MR images. According to their distance to the vertebra contour, the data points were grouped in five regions of interest (ROIs): cortical bone (-1 mm to 0 mm), pre-cortical zone (PCZ) 1-3 (0-1 mm; 1-2 mm; 2-3 mm), and cancellous bone ([Formula: see text] 3 mm). For PCZ1 vs. PCZ2, a significant difference in mean PDFF of between -7.59 pp and -4.39 pp on average was found. For cortical bone vs. PCZ1, a significant difference in mean PDFF of between -27.09 pp and -18.96 pp on average was found. CONCLUSION: A relationship between distance from the cortical bone boundary and lipid content could be established, paving the way for guidance techniques based on fat fraction detection for spinal surgery.

A novel Veress needle mechanism that reduces overshooting after puncturing the abdominal wall.

BACKGROUND: Complications that occur in laparoscopic surgery are often associated with the initial entry into the peritoneal cavity. The literature reported incidences of Veress needle (VN) injuries of e.g. 0.31% and 0.23%. In a 2010 national survey of laparoscopic entry techniques in the Canadian General Surgical practice, 57.3% of respondents had either experienced or witnessed a serious laparoscopic entry complication like bowel perforation and vascular injury. As those complications are potentially life threatening and should be avoided at all costs, improving safety of this initial action is paramount. METHODS: Based on a bare minimum design approach with focus on function expansion of existing components, a new Safety mechanism was developed for the VN that decreases the risks of VN overshooting. The mechanism works by preventing the puncturing acceleration of the tip of the VN by decoupling the surgeon's hand from the VN immediately after entering the abdomen. RESULTS: Based on a set of requirements, a first prototype of the VN+ with force decoupling safety mechanism is presented and evaluated on an ex vivo porcine abdominal wall tissue model in a custom setup. The experiments conducted by two novices and one experienced surgeon indicated a significant difference between the attempts with a standard, conventional working VN (41.4 mm [37.5-45 mm]) and VN+ with decoupling mechanism (20.8 mm [17.5-22.5 mm]) of p < 0.001. CONCLUSION: A new decoupling safety mechanism was integrated successfully in a standard VN resulting in a VN+ . The results from the pilot study indicate that this new VN+ reduces overshooting with a minimum of 50% in a standardised ex vivo setting on fresh porcine abdominal wall specimens.

Diffuse reflectance spectroscopy for breach detection during pedicle screw placement: a first in vivo investigation in a porcine model.

BACKGROUND: The safe and accurate placement of pedicle screws remains a critical step in open and minimally invasive spine surgery, emphasizing the need for intraoperative guidance techniques. Diffuse reflectance spectroscopy (DRS) is an optical sensing technology that may provide intraoperative guidance in pedicle screw placement. PURPOSE: The study presents the first in vivo minimally invasive procedure using DRS sensing at the tip of a Jamshidi needle with an integrated optical K-wire. We investigate the effect of tissue perfusion and probe-handling conditions on the reliability of fat fraction measurements for breach detection in vivo. METHODS: A Jamshidi needle with an integrated fiber-optic K-wire was gradually inserted into the vertebrae under intraoperative image guidance. The fiber-optic K-wire consisted of two optical fibers with a fiber-to-fiber distance of 1.024 mm. DRS spectra in the wavelength range of 450 to 1600 nm were acquired at several positions along the path inside the vertebrae. Probe-handling conditions were varied by changing the amount of pressure exerted on the probe within the vertebrae. Continuous spectra were recorded as the probe was placed in the center of the vertebral body while the porcine specimen was sacrificed via a lethal injection. RESULTS: A typical insertion of the fiber-optic K-wire showed a drop in fat fraction during an anterior breach as the probe transitioned from cancellous to cortical bone. Fat fraction measurements were found to be similar irrespective of the amount of pressure exerted on the probe (p = 0.65). The 95% confidence interval of fat fraction determination was found in the narrow range of 1.5-3.6% under various probe-handling conditions. The fat fraction measurements remained stable during 70 min of decreased blood flow after the animal was sacrificed. DISCUSSIONS: These findings indicate that changes in tissue perfusion and probe-handling conditions have a relatively low measureable effect on the DRS signal quality and thereby on the determination of fat fraction as a breach detection signal. CONCLUSIONS: Fat fraction quantification for intraoperative pedicle screw breach detection is reliable, irrespective of changes in tissue perfusion and probe-handling conditions.

Directions for surgical capacity developments in Nepal: a population-based assessment.

OBJECTIVES: Lack of access to safe surgery is seen as a major issue that needs to be addressed. The aim of this study was to understand which combinations of factors relate to high occurrences of unmet needs and disability in Nepal, and consequently, how to focus future work to maximise impact in this country. METHODS: A large population-based survey was conducted in Nepal in 2014 to evaluate the unmet surgical needs that result in disability. Recorded factors included diseased anatomical areas, disease specifics, disease locations, injury types, reasons for having an unmet need and the types of disability. RESULTS: Included in the study were 2695 individuals. The anatomical areas facing the highest disabling unmet surgical need were Head (3.9% of population), Groin/Genitalia (2.2% of population) and Extremities (3.6% of population). Four focus areas could be defined. Increase affordability, availability and acceptability of surgical care to non-traumatic disabling conditions of (i) the eye, and (ii) extremities, and (iii) to traumatic disabling conditions of extremities and finally (iv) increase acceptability of having surgical care for non-traumatic conditions in the groin and genital area. For the latter, fear/no trust was the main reason for receiving no surgical care despite the resulting shame. CONCLUSIONS: This study defined four focus areas that showed the largest unmet needs that resulted in a perceived disability. For those areas, affordability, availability and acceptability of surgical need to be addressed through technical developments, capacity building and raising awareness.

OBJECTIFS: L'absence d'accès à une chirurgie sûre est considérée comme un problème majeur à résoudre. Le but de cette étude était de comprendre quelles combinaisons de facteurs étaient liées aux besoins non satisfaits et aux incapacités au Népal, et par conséquent, comment cibler les travaux futurs pour maximiser l'impact dans ce pays. MÉTHODES: Une vaste enquête de population a été menée au Népal en 2014 pour évaluer les besoins chirurgicaux non satisfaits qui entraînent une incapacité. Les facteurs enregistrés comprenaient les zones anatomiques, les spécificités, les localisations de la maladie, les types de blessures, les raisons pour lesquelles les besoins n'étaient pas satisfaits et les types d'incapacité. RÉSULTATS: 2695 personnes ont été incluses dans l'étude. Les zones anatomiques impliquées dans des besoins chirurgicaux les plus invalidants étaient les suivantes: tête (3,9% de la population), aine/organes génitaux (2,2% de la population) et extrémités (3,6% de la population). Quatre domaines cibles d'intervention pourraient être définis. Premièrement, augmenter l'accessibilité financière, la disponibilité et l'acceptabilité des soins chirurgicaux aux affections invalidantes non traumatiques de 1) l'œil, 2) des extrémités et 3) aux affections traumatisantes des extrémités, et enfin 4) augmenter l'acceptabilité des soins chirurgicaux pour les affections non traumatiques dans l'aine et les parties génitales. Pour ces derniers, la crainte/l'absence de confiance était la principale raison de ne pas recevoir de soins chirurgicaux malgré la honte qui en résultait. CONCLUSIONS: Cette étude a défini quatre domaines cibles d'intervention qui ont montré les besoins non satisfaits les plus importants ayant entraîné une incapacité perçue. Pour ces domaines, il convient de prendre en compte le caractère abordable, la disponibilité et l'acceptabilité des interventions chirurgicales par le biais de développements techniques, d'un renforcement des capacités et la sensibilisation.

A new modular mechanism that allows full detachability and cleaning of steerable laparoscopic instruments.

BACKGROUND: Ever since the introduction of laparoscopic surgery, researchers have been trying to add steerability to instruments to allow the surgeon to operate with better reachability and less tissue interaction force. Traditional solutions to introduce this often use a combination of springs, cables, pulleys, and guiding structures, resulting in instruments that cannot be properly cleaned and thus are very costly to manufacture and maintain. The aim of the study is to develop a novel affordable, sustainable, cableless, and fully steerable laparoscopic grasper, and to test its ease of assembly, disassembly, and use. METHODS: A set of requirements was defined to ensure that the instrument can be handled efficiently at the sterilization unit and in the operating room. Based on these, a multisteerable, cableless 5 mm laparoscopic instrument that operates based on shaft rotations was developed. To test its assembly and disassembly, ten participants were asked to fully dismantle the instrument and reassemble it a total of 60 times. In addition, ten medical students were asked to use the grasper in the ForceSense box-trainer system on a newly developed 3D pick-and-place task, to determine the control effort based on learning curves of steering errors, task time, instrument path length, and maximum tissue interaction force. RESULTS: All important design requirements were met. The recorded data indicates that ten engineering students were able to fully dismantle and reassemble the instrument shaft in 12 s (SD7) and 65 s (SD43) seconds at the sixth attempt. The learning-curve data indicates that three attempts were needed before the ten medical students started to use all steering functions. At the sixth attempt, on average only 1.25 (SD0.7) steering errors were made. The steepest slope in the learning curves for steering errors, path length, and task time was experienced during the first three attempts. In respect of the interaction force, no learning effect was observed. CONCLUSION: The multi-DOF (degree of freedom) cableless grasper can be assembled and disassembled for cleaning and sterilization within an acceptable time frame. The handle interface proved to be intuitive enough for novices to conduct a complex 3D pick-and-place task in a training setting.

Surgical process modelling strategies: which method to choose for determining workflow?

The vital role of surgeries in healthcare requires a constant attention to improvement. Surgical process modelling is an innovative and rather recently introduced approach for tackling the issues in today's complex surgeries. This modelling field is very challenging and still under development, therefore, it is not always clear which modelling strategy would best fit the needs in which situations. The aim of this study was to provide a guide for matching the choice of modelling strategies for determining surgical workflows. In this work, the concepts associated with surgical process modelling are described, aiming to clarify them and to promote their use in future studies. The relationship of these concepts and the possible combinations of the suitable approaches for modelling strategies are elaborated and the criteria for opting for the proper modelling strategy are discussed.

Electrosurgery: short-circuit between education and practice.

Introduction: Electrosurgery is used in 80% of surgical procedures. The technique allows surgeons to skilfully dissect tissues and achieve haemostasis. Since improper use of electrosurgery can lead to serious adverse events, training is required to potentially reduce the number and severity of these events. In this study we evaluate education and training in electrosurgery for surgical residents. Material and methods: Residents from six surgical subspecialties in the Netherlands were invited to anonymously complete a digital questionnaire about training, supervision and adverse events regarding electrosurgery. Results: Of the 197 respondents, 69% had received some form of training; mostly a single theoretical lecture. The feeling of competence in theory and practical skills was positively rated by 39% and 71%, respectively. Moreover, 35% judged the theoretical knowledge of their supervisors as insufficient and 65% changed their electrosurgical application technique to the preference of the supervisor. 30% of the residents had encountered a serious adverse event (e.g., burn wounds) related to the application of electrosurgery. Conclusions: The training of residents in theoretical aspects of electrosurgery is limited. Residents are not satisfied with the acquired theoretical knowledge of themselves and of their supervisors. Since adverse events related to electrosurgery occur frequently, more extensive education for both residents and their supervisors is needed to enhance patient safety.

Measuring surgical safety during minimally invasive surgical procedures: a validation study.

BACKGROUND: During the implementation of new interventions (i.e., surgical devices and technologies) in the operating room, surgical safety might be compromised. Current safety measures are insufficient in detecting safety hazards during this process. The aim of the study was to observe whether surgical teams are capable of measuring surgical safety, especially with regard to the introduction of new interventions. METHODS: A Surgical Safety Questionnaire was developed that had to be filled out directly postoperative by three surgical team members. A potential safety concern was defined as at least one answer between (strongly) disagree and indifferent. The validity of the questionnaire was assessed by comparison with the results from video analysis. Two different observers annotated the presence and effect of surgical flow disturbances during 40 laparoscopic hysterectomies performed between November 2010 and April 2012. RESULTS: The surgeon reported a potential safety concern in 16% (85/520 questions). With respect to the scrub nurse and anesthesiologist, this was both 9% (46/520). With respect to the preparation, functioning, and ease of use of the devices in 37.5-47.5% (15-19/40 procedures) a potential safety concern was reported by one or more team members. During procedures after which a potential safety concern was reported, surgical flow disturbances lasted a higher percentage of the procedure duration [9.3 ± 6.2 vs. 2.9 ± 3.7% (mean ± SD), p < .001]. After procedures during which a new instrument or device was used, more potential safety concerns were reported (51.2 vs. 23.1%, p < .001). CONCLUSIONS: Potential safety concerns were especially reported during procedures in which a relatively high percentage of the duration consisted of surgical flow disturbances and during procedures in which a new instrument or device was used. The Surgical Safety Questionnaire can act as a validated tool to evaluate and maintain surgical safety during minimally invasive procedures, especially during the introduction of a new intervention.

Endpoint Accuracy in Manual Control of a Steerable Needle.

PURPOSE: To study the ability of a human operator to manually correct for errors in the needle insertion path without partial withdrawal of the needle by means of an active, tip-articulated steerable needle. MATERIALS AND METHODS: The needle is composed of a 1.32-mm outer-diameter cannula, with a flexure joint near the tip, and a retractable stylet. The bending stiffness of the needle resembles that of a 20-gauge hypodermic needle. The needle functionality was evaluated in manual insertions by steering to predefined targets and a lateral displacement of 20 mm from the straight insertion line. Steering tasks were conducted in 5 directions and 2 tissue simulants under image guidance from a camera. The repeatability in instrument actuations was assessed during 100 mm deep automated insertions with a linear motor. In addition to tip position, tip angles were tracked during the insertions. RESULTS: The targeting error (mean absolute error ± standard deviation) during manual steering to 5 different targets in stiff tissue was 0.5 mm ± 1.1. This variability in manual tip placement (1.1 mm) was less than the variability among automated insertions (1.4 mm) in the same tissue type. An increased tissue stiffness resulted in an increased lateral tip displacement. The tip angle was directly controlled by the user interface, and remained unaffected by the tissue stiffness. CONCLUSIONS: This study demonstrates the ability to manually steer needles to predefined target locations under image guidance.

Improving training of laparoscopic tissue manipulation skills using various visual force feedback types.

BACKGROUND: Visual force feedback allows trainees to learn laparoscopic tissue manipulation skills. The aim of this experimental study was to find the most efficient visual force feedback method to acquire these skills. Retention and transfer validity to an untrained task were assessed. METHODS: Medical students without prior experience in laparoscopy were randomized in three groups: Constant Force Feedback (CFF) (N = 17), Bandwidth Force Feedback (BFF) (N = 16) and Fade-in Force Feedback (N = 18). All participants performed a pretest, training, post-test and follow-up test. The study involved two dissimilar tissue manipulation tasks, one for training and one to assess transferability. Participants performed six trials of the training task. A force platform was used to record several force parameters. RESULTS: A paired-sample t test showed overall lower force parameter outcomes in the post-test compared to the pretest (p < .001). A week later, the force parameter outcomes were still significantly lower than found in the pretest (p < .005). Participants also performed the transfer task in the post-test (p < .02) and follow-up (p < .05) test with lower force parameter outcomes compared to the pretest. A one-way MANOVA indicated that in the post-test the CFF group applied 50 % less Mean Absolute Nonzero Force (p = .005) than the BFF group. CONCLUSION: All visual force feedback methods showed to be effective in decreasing tissue manipulation force as no major differences were found between groups in the post and follow-up trials. The BFF method is preferred for it respects individual progress and minimizes distraction.

Surgical flow disturbances in dedicated minimally invasive surgery suites: an observational study to assess its supposed superiority over conventional suites.

BACKGROUND: Minimally invasive surgery (MIS) is frequently compromised by surgical flow disturbances due to technology- and equipment-related failures. Compared with MIS in a conventional cart-based OR, performing MIS in a dedicated integrated operating room (OR) is supposed to be beneficial to patient safety. The aim of this study was to compare a conventional OR with an integrated OR with regard to the incidence and effect of equipment-related surgical flow disturbances during an advanced laparoscopic gynecological procedure [laparoscopic hysterectomy (LH)]. METHODS: Using video recording, 40 LHs performed between November 2010 and April 2012 (20 in a conventional cart-based OR and 20 in an integrated OR) were analyzed by two different observers. Outcome measures were the number, duration and effect (on a seven-point ordinal scale) of the surgical flow disturbances (e.g., malfunctioning, intraoperative repositioning, setup device). RESULTS: A total of 103 h and 45 min was observed. The interobserver agreement was high (kappa .85, p < .001). Procedure time was not significantly different (NS) [conventional OR vs. integrated OR, minutes ± standard deviation (SD), mean 161 ± 27 vs. 150 ± 34]. A total of 1651 surgical flow disturbances were observed (mean ± SD per procedure 40.8 ± 19.4 vs. 41.8 ± 15.9, NS). The mean number of surgical flow disturbances per procedure with regard to equipment was 6.3 ± 3.7 versus 8.5 ± 4.0, NS. No clinically relevant differences in the mean effect of these disturbances on the surgical flow between the two OR setups were observed. CONCLUSIONS: Performing LH in an integrated OR did not reduce the number of surgical flow disturbances nor the effect of these disturbances. Furthermore, in the integrated OR, repositioning of the monitors was a frequent and time-consuming source of disturbance. In order to maintain the high standard of surgical safety, the entire surgical team has to be aware that by performing surgery in an integrated OR different potential source for disruption arise.

The Art of Electrosurgery: Trainees and Experts.

The benefits of electrosurgery have been acknowledged since the early 1920s, and nowadays more than 80% of surgical procedures involve devices that apply energy to tissues. Despite its widespread use, it is currently unknown how the operator's choices with regard to instrument selection and application technique are related to complications. As such, the manner in which electrosurgery is applied can have a serious influence on the outcome of the procedure and the well-being of patients. The aim of this study is to investigate the variety of differences in usage of electrosurgical devices. Our approach is to measure these parameters to provide insight into application techniques. A sensor was developed that records the magnitude of electric current delivered to an electrosurgical device at a frequency of 10 Hz. The sensor is able to detect device activation times and a reliable estimate of the power-level settings. Data were recorded for 91 laparoscopic cholecystectomies performed by different surgeons and residents. Results of the current measurement data show differences in the way electrosurgery is applied by surgeons and residents during a laparoscopic cholecystectomy. Variations are seen in the number of activations, the activation time, and the approach for removal of the gallbladder. Analysis showed that experienced surgeons have a longer activation time than residents (3.01 vs 1.41 seconds, P < .001) and a lower number of activations (102 vs 123). This method offers the opportunity to relate application techniques to clinical outcome and to provide input for the development of a best practice model.

Workflow and intervention times of MR-guided focused ultrasound - Predicting the impact of new techniques.

Magnetic resonance guided focused ultrasound surgery (MRgFUS) has become an attractive, non-invasive treatment for benign and malignant tumours, and offers specific benefits for poorly accessible locations in the liver. However, the presence of the ribcage and the occurrence of liver motion due to respiration limit the applicability MRgFUS. Several techniques are being developed to address these issues or to decrease treatment times in other ways. However, the potential benefit of such improvements has not been quantified. In this research, the detailed workflow of current MRgFUS procedures was determined qualitatively and quantitatively by using observation studies on uterine MRgFUS interventions, and the bottlenecks in MRgFUS were identified. A validated simulation model based on discrete events simulation was developed to quantitatively predict the effect of new technological developments on the intervention duration of MRgFUS on the liver. During the observation studies, the duration and occurrence frequencies of all actions and decisions in the MRgFUS workflow were registered, as were the occurrence frequencies of motion detections and intervention halts. The observation results show that current MRgFUS uterine interventions take on average 213min. Organ motion was detected on average 2.9 times per intervention, of which on average 1.0 actually caused a need for rework. Nevertheless, these motion occurrences and the actions required to continue after their detection consumed on average 11% and up to 29% of the total intervention duration. The simulation results suggest that, depending on the motion occurrence frequency, the addition of new technology to automate currently manual MRgFUS tasks and motion compensation could potentially reduce the intervention durations by 98.4% (from 256h 5min to 4h 4min) in the case of 90% motion occurrence, and with 24% (from 5h 19min to 4h 2min) in the case of no motion. In conclusion, new tools were developed to predict how intervention durations will be affected by future workflow changes and by the introduction of new technology.

Where are my instruments? Hazards in delivery of surgical instruments.

BACKGROUND: Unavailability of instruments is recognised to cause delays and stress in the operating room, which can lead to additional risks for the patients. The aim was to provide an overview of the hazards in the entire delivery process of surgical instruments and to provide insight into how Information Technology (IT) could support this process in terms of information availability and exchange. METHODS: The process of delivery was described according to the Healthcare Failure Mode and Effects Analysis methodology for two hospitals. The different means of information exchange and availability were listed. Then, hazards were identified and further analysed for each step of the process. RESULTS: For the first hospital, 172 hazards were identified, and 23 of hazards were classified as high risk. Only one hazard was considered as 'controlled' (when actions were taken to remove the hazard later in the process). Twenty-two hazards were 'tolerated' (when no actions were taken, and it was therefore accepted that adverse events may occur). For the second hospital, 158 hazards were identified, and 49 of hazards were classified as high risk. Eight hazards were 'controlled' and 41 were 'tolerated'. The means for information exchange and information systems were numerous for both cases, while there was not one system that provided an overview of all relevant information. CONCLUSIONS: The majority of the high-risk hazards are expected to be controlled by the use of IT support. Centralised information and information availability for different parties reduce risks related to unavailability of instruments in the operating room.

Fully automated predictive intelligent control of oxygenation (PRICO) in resuscitation and ventilation of preterm lambs.

BACKGROUND: Hyperoxia and hypoxia influence morbidity and mortality of preterm infants. Automated closed-loop control of the fraction of inspired oxygen (FiO(2)) has been shown to facilitate oxygen supplementation in the neonatal intensive care unit (NICU), but has not yet been tested during preterm resuscitation. We hypothesized that fully automated FiO(2) control based on predefined oxygen saturation (SpO(2)) targets was applicable in both preterm resuscitation and ventilation. METHODS: Twenty-two preterm lambs were operatively delivered and intubated in a modified EXIT procedure. They were randomized to receive standardized resuscitation with either automated or manual FiO(2) control, targeting SpO(2) according to the Dawson curve in the first 10 min and SpO(2) 90-95% hereafter. Automated FiO(2) control also was applied during surfactant replacement therapy and subsequent ventilation. RESULTS: Time within target range did not differ significantly between manual and automated FiO(2) control during resuscitation, however automated FiO(2) control significantly avoided hyperoxia. Automated FiO(2) control was feasible during surfactant replacement and kept SpO(2) within target range significantly better than manual control during subsequent ventilation. CONCLUSION: In our model, fully automated FiO(2) control was feasible in rapidly changing physiologic conditions during postnatal resuscitation and prevented hyperoxia. We conclude that closed loop FiO(2) control is a promising tool for the delivery room.