Generation of a Realistic Synthetic Laryngeal Cancer Cohort for AI Applications.

BACKGROUND: Obtaining large amounts of real patient data involves great efforts and expenses, and processing this data is fraught with data protection concerns. Consequently, data sharing might not always be possible, particularly when large, open science datasets are needed, as for AI development. For such purposes, the generation of realistic synthetic data may be the solution. Our project aimed to generate realistic cancer data with the use case of laryngeal cancer. METHODS: We used the open-source software Synthea and programmed an additional module for development, treatment and follow-up for laryngeal cancer by using external, real-world (RW) evidence from guidelines and cancer registries from Germany. To generate an incidence-based cohort view, we randomly drew laryngeal cancer cases from the simulated population and deceased persons, stratified by the real-world age and sex distributions at diagnosis. RESULTS: A module with age- and stage-specific treatment and prognosis for laryngeal cancer was successfully implemented. The synthesized population reflects RW prevalence well, extracting a cohort of 50,000 laryngeal cancer patients. Descriptive data on stage-specific and 5-year overall survival were in accordance with published data. CONCLUSIONS: We developed a large cohort of realistic synthetic laryngeal cancer cases with Synthea. Such data can be shared and published open source without data protection issues.

Towards safer imaging: A comparative study of deep learning-based denoising and iterative reconstruction in intraindividual low-dose CT scans using an in-vivo large animal model.

PURPOSE: Computed tomography (CT) scans are a significant source of medically induced radiation exposure. Novel deep learning-based denoising (DLD) algorithms have been shown to enable diagnostic image quality at lower radiation doses than iterative reconstruction (IR) methods. However, most comparative studies employ low-dose simulations due to ethical constraints. We used real intraindividual animal scans to investigate the dose-reduction capabilities of a DLD algorithm in comparison to IR. MATERIALS AND METHODS: Fourteen veterinarian-sedated alive pigs underwent 2 CT scans on the same 3rd generation dual-source scanner with two months between each scan. Four additional scans ensued each time, with mAs reduced to 50 %, 25 %, 10 %, and 5 %. All scans were reconstructed ADMIRE levels 2 (IR2) and a novel DLD algorithm, resulting in 280 datasets. Objective image quality (CT numbers stability, noise, and contrast-to-noise ratio) was measured via consistent regions of interest. Three radiologists independently rated all possible dataset combinations per time point for subjective image quality (-1 = inferior, 0 = equal, 1 = superior). The points were averaged for a semiquantitative score, and inter-rater agreement was measured using Spearman's correlation coefficient and adequately corrected mixed-effects modeling analyzed objective and subjective image quality. RESULTS: Neither dose-reduction nor reconstruction method negatively impacted CT number stability (p > 0.999). In objective image quality assessment, the lowest radiation dose achievable by DLD when comparing noise (p = 0.544) and CNR (p = 0.115) to 100 % IR2 was 25 %. Overall, inter-rater agreement of the subjective image quality ratings was strong (r ≥ 0.69, mean 0.93 ± 0.05, 95 % CI 0.92-0.94; each p < 0.001), and subjective assessments corroborated that DLD at 25 % radiation dose was comparable to 100 % IR2 in image quality, sharpness, and contrast (p ≥ 0.281). CONCLUSIONS: The DLD algorithm can achieve image quality comparable to the standard IR method but with a significant dose reduction of up to 75%. This suggests a promising avenue for lowering patient radiation exposure without sacrificing diagnostic quality.

Colorectal Endoscopic Submucosal Dissection: Performance of a Novel Hybrid-Technology Knife in an Animal Trial.

Endoscopic submucosal dissection (ESD) was developed for the removal of benign and early malignant lesions in the gastrointestinal tract. We aimed to evaluate the performance and safety of a novel high-pressure waterjet-assisted ESD knife in colorectal applications. Six female German Landrace pigs with an average weight of 62 kg (range 60-65 kg) were used in this prospective, randomized, and controlled study. Twenty-four ESDs were performed by three endoscopists: Twelve each with the new Erbe HYBRIDknife® flex T-Type (HK-T) and the Olympus DualKnife® J (DK-J), including six rectal and six colonic ESDs per instrument. The order of performance was randomized regarding anatomic position and instrument. As the primary endpoint, ESD knife performance characteristics were combined and rated on a 5-point Likert scale, with 5 Likert points (LP) representing the best response (5 = very good). The HK-T was rated significantly better than the DK-J (4.7 LP versus 4.4 LP, p = 0.0295), mainly because of HK-T injection ability (5 LP versus 3 LP, p < 0.0001) and hemostasis (5 LP versus 4 LP, p = 0.0452). There was no difference in procedure time (HK-T: 35 min versus DK-J: 34 min, p = 0.8005), resection diameter (3.1 cm versus 2.8 cm, p = 0.3492), injection volume (41 mL versus 46 mL, p = 0.5633), and complication rates. HK-T is as effective as DK-J in colorectal ESD in terms of dissection quality but has better injection and hemostatic properties. The impact of these technical advantages on the ESD treatment of patients with large superficial colorectal lesions remains to be clinically verified.

A comparison between a maximum care university hospital and an outpatient clinic - potential for optimization in arthroscopic workflows?

BACKGROUND: Due to the growing economic pressure, there is an increasing interest in the optimization of operational processes within surgical operating rooms (ORs). Surgical departments are frequently dealing with limited resources, complex processes with unexpected events as well as constantly changing conditions. In order to use available resources efficiently, existing workflows and processes have to be analyzed and optimized continuously. Structural and procedural changes without prior data-driven analyses may impair the performance of the OR team and the overall efficiency of the department. The aim of this study is to develop an adaptable software toolset for surgical workflow analysis and perioperative process optimization in arthroscopic surgery. METHODS: In this study, the perioperative processes of arthroscopic interventions have been recorded and analyzed subsequently. A total of 53 arthroscopic operations were recorded at a maximum care university hospital (UH) and 66 arthroscopic operations were acquired at a special outpatient clinic (OC). The recording includes regular perioperative processes (i.a. patient positioning, skin incision, application of wound dressing) and disruptive influences on these processes (e.g. telephone calls, missing or defective instruments, etc.). For this purpose, a software tool was developed ('s.w.an Suite Arthroscopic toolset'). Based on the data obtained, the processes of the maximum care provider and the special outpatient clinic have been analyzed in terms of performance measures (e.g. Closure-To-Incision-Time), efficiency (e.g. activity duration, OR resource utilization) as well as intra-process disturbances and then compared to one another. RESULTS: Despite many similar processes, the results revealed considerable differences in performance indices. The OC required significantly less time than UH for surgical preoperative (UH: 30:47 min, OC: 26:01 min) and postoperative phase (UH: 15:04 min, OC: 9:56 min) as well as changeover time (UH: 32:33 min, OC: 6:02 min). In addition, these phases result in the Closure-to-Incision-Time, which lasted longer at the UH (UH: 80:01 min, OC: 41:12 min). CONCLUSION: The perioperative process organization, team collaboration, and the avoidance of disruptive factors had a considerable influence on the progress of the surgeries. Furthermore, differences in terms of staffing and spatial capacities could be identified. Based on the acquired process data (such as the duration for different surgical steps or the number of interfering events) and the comparison of different arthroscopic departments, approaches for perioperative process optimization to decrease the time of work steps and reduce disruptive influences were identified.

How Real Are Computed Tomography Low Dose Simulations? An Investigational In-Vivo Large Animal Study.

OBJECTIVES: CT low-dose simulation methods have gained significant traction in protocol development, as they lack the risk of increased patient exposure. However, in-vivo validations of low-dose simulations are as uncommon as prospective low-dose image acquisition itself. Therefore, we investigated the extent to which simulated low-dose CT datasets resemble their real-dose counterparts. MATERIALS AND METHODS: Fourteen veterinarian-sedated alive pigs underwent three CT scans on the same third generation dual-source scanner with 2 months between each scan. At each time, three additional scans ensued, with mAs reduced to 50%, 25%, and 10%. All scans were reconstructed using wFBP and ADMIRE levels 1-5. Matching low-dose datasets were generated from the 100% scans using reconstruction-based and DICOM-based simulations. Objective image quality (CT numbers stability, noise, and signal-to-noise ratio) was measured via consistent regions of interest. Three radiologists independently rated all possible dataset combinations per time point for subjective image quality (-1=inferior, 0=equal, 1=superior). The points were averaged for a semiquantitative score, and inter-rater-agreement was measured using Spearman's correlation coefficient. A structural similarity index (SSIM) analyzed the voxel-wise similarity of the volumes. Adequately corrected mixed-effects analysis compared objective and subjective image quality. Multiple linear regression with three-way interactions measured the contribution of dose, reconstruction mode, simulation method, and rater to subjective image quality. RESULTS: There were no significant differences between objective and subjective image quality of reconstruction-based and DICOM-based simulation on all dose levels (p≥0.137). However, both simulation methods produced significantly lower objective image quality than real-dose images below 25% mAs due to noise overestimation (p<0.001; SSIM≤89±3). Overall, inter-rater-agreement was strong (r≥0.68, mean 0.93±0.05, 95% CI 0.92-0.94; each p<0.001). In regression analysis, significant decreases in subjective image quality were observed for lower radiation doses (b ≤ -0.387, 95%CI -0.399 to -0.358; p<0.001) but not for reconstruction modes, simulation methods, raters, or three-way interactions (p≥0.103). CONCLUSION: Simulated low-dose CT datasets are subjectively and objectively indistinguishable from their real-dose counterparts down to 25% mAs, making them an invaluable tool for efficient low-dose protocol development.

Initial Crystallization Effects in Coarse-Grained Polyethylene Systems After Uni- and Biaxial Stretching in Blow-Molding Cooling Scenarios.

This study investigates the initial stage of the thermo-mechanical crystallization behavior for uni- and biaxially stretched polyethylene. The models are based on a mesoscale molecular dynamics approach. We take constraints that occur in real-life polymer processing into account, especially with respect to the blowing stage of the extrusion blow-molding process. For this purpose, we deform our systems using a wide range of stretching levels before they are quenched. We discuss the effects of the stretching procedures on the micro-mechanical state of the systems, characterized by entanglement behavior and nematic ordering of chain segments. For the cooling stage, we use two different approaches which allow for free or hindered shrinkage, respectively. During cooling, crystallization kinetics are monitored: We precisely evaluate how the interplay of chain length, temperature, local entanglements and orientation of chain segments influence crystallization behavior. Our models reveal that the main stretching direction dominates microscopic states of the different systems. We are able to show that crystallization mainly depends on the (dis-)entanglement behavior. Nematic ordering plays a secondary role.

A new bipolar device for sealing and cutting: ex and in vivo studies for performance evaluation.

INTRODUCTION: A novel multipurpose bipolar radiofrequency instrument, the Erbe Dissector (EDS), which simultaneously seals and cuts tissue, was developed. Ex vivo sealing rate and time, burst pressure, jaw temperature and thermal spread were studied in porcine renal arteries. MATERIAL AND METHODS: In vivo, 13 surgical tasks were performed in two pigs: beside sealing rate and time, overall performance in sharp and blunt dissection, tissue sticking, hemostasis, precision, etc., were evaluated by four surgeons compared with ENSEAL G2 (EG2) using surveys on a Likert scale (1 = very poor; 5 = very good). RESULTS: Ex vivo, the EDS sealing rate was 91.7% (33/36 arteries) at an average sealing time of 2.1 s (range 1.7-2.8) and a burst pressure of 1040 ± 350 mmHg. The maximum jaw temperature was 87 ± 4 °C and the mean lateral thermal spread was 0.8 ± 0.2 mm. In vivo, the sealing rate for arteries and veins was 92.6% (50/54) and the median seal and cut time was 1.6 s (range: 1.3-2.9). The average EDS performance score across all tasks was 4.4 ± 0.6 Likert points. For five shared tasks, EDS was better than EG2 (4.4 ± 0.5 versus 3.4 ± 0.6 Likert points; p = 0.016). CONCLUSIONS: EDS seals and cuts arteries and veins rapidly with good safety and user-friendliness.

Early biomarkers predicting outcome in a porcine model of acetaminophen intoxication: A pilot study.

BACKGROUND: Acetaminophen intoxication has become the leading cause of acute liver failure (ALF) in Europe and the USA. OBJECTIVES: To identify early biomarkers in order to predict the development of ALF in a porcine model of acetaminophen intoxication. MATERIAL AND METHODS: Six German Landrace pigs received a single acetaminophen bolus of 1 g/kg body weight via a jejunal catheter. Cytokines and laboratory parameters were analyzed at 8-hour intervals for a total of 40 h. RESULTS: Three of the 6 animals survived the intoxication. The nonsurviving animals had an increase in serum lactate and interleukin (IL)-6, with a simultaneous decrease in prothrombin time (PT) and albumin concentration 8 h after intoxication. In all nonsurviving animals, elevated levels of tumor necrosis factor alpha (TNF-α) at baseline before intoxication and during the course of ALF were observed. The acetaminophen serum concentrations and toxicokinetics did not differ between the nonsurviving and surviving animals. Methemoglobinemia was proportional to the administered doses and acetaminophen blood levels, but methemoglobinemia did not affect survival. CONCLUSIONS: Tumor necrosis factor alpha, IL-6, lactate, prothrombin time, and albumin blood concentration were identified as early predictors of outcome after acetaminophen intoxication. An elevated TNF-α level before acetaminophen exposure was the earliest prognostic marker for a lethal outcome. Therefore, it could serve as a very early indicator of prognosis.

Standardized procedure prevents perioperative and early complications in totally implantable venous-access ports-a complication analysis of more than 1000 TIVAP implantations.

PURPOSE: Since their invention 40 years ago, totally implantable venous-access ports (TIVAPs) have become indispensable in cancer treatment. The aim of our study was to analyze complications under standardized operative and perioperative procedures and to identify risk factors for premature port catheter explantation. METHODS: A total of 1008 consecutive TIVAP implantations were studied for success rate, perioperative, early, and late complications. Surgical, clinical, and demographic factors were analyzed as potential risk factors for emergency port catheter explantation. RESULTS: Successful surgical TIVAP implantation was achieved in 1005/1008 (99.7%) cases. No intraoperative or perioperative complications occurred. A total of 32 early complications and 88 late complications were observed leading to explantation in 11/32 (34.4%) and 34/88 (38.6%) cases, respectively. The most common complications were infections in 4.7% followed by thrombosis in 3.6%. Parameters that correlated with unplanned TIVAP explantation were gender (port in situ: female 95% vs. male 91%, p = 0.01), underlying disease (breast cancer 97% vs. gastrointestinal 89%, p = 0.004), indication (chemotherapy 95% vs. combination of chemotherapy and parenteral nutrition 64%, p < 0.0001), and type of complication (infection 13.4% vs. TIVAP-related complication 54% and thrombosis 95%, p < 0.0001). CONCLUSION: Standardized operative and perioperative TIVAP implantation procedures provide excellent results and low explantation rate.

Retrospective analysis of different therapeutic approaches for retroperitoneal duodenal perforations.

Surgical therapy of duodenal perforation into the retroperitoneum entails high morbidity. Conservative treatment and endoscopic negative pressure therapy have been suggested as promising therapeutic alternatives. We aimed to retrospectively assess outcomes of patients treated for duodenal perforation to the retroperitoneum at our department. A retrospective analysis of all patients that were treated for duodenal perforation to the retroperitoneum at our institution between 2010 and 2021 was conducted. Different therapeutic approaches with associated complications within 30 days, length of in-hospital stay, number of readmissions and necessity of parenteral nutrition were assessed. We included thirteen patients in our final analysis. Six patients underwent surgery, five patients were treated conservatively and two patients received interventional treatment by endoscopic negative pressure therapy. Length of stay was shorter in patients treated conservatively. One patient following conservative and surgical treatment each was readmitted to hospital within 30 days after initial therapy whereas no readmissions after interventional treatment occurred. There was no failure of therapy in patients treated without surgery whereas four (66.7%) of six patients required revision surgery following primary surgical therapy. Conservative and interventional treatment were associated with fewer complications than surgical therapy which involves high morbidity. Conservative and interventional treatment using endoscopic negative pressure therapy in selected patients might constitute appropriate therapeutic alternatives for duodenal perforations to the retroperitoneum.

Replacing Needle Injection by a Novel Waterjet Technology Grants Improved Muscle Cell Delivery in Target Tissues.

Current regimen to treat patients suffering from stress urinary incontinence often seems not to yield satisfactory improvement or may come with severe side effects. To overcome these hurdles, preclinical studies and clinical feasibility studies explored the potential of cell therapies successfully and raised high hopes for better outcome. However, other studies were rather disappointing. We therefore developed a novel cell injection technology to deliver viable cells in the urethral sphincter complex by waterjet instead of using injection needles. We hypothesized that the risk of tissue injury and loss of cells could be reduced by a needle-free injection technology. Muscle-derived cells were obtained from young male piglets and characterized. Upon expansion and fluorescent labeling, cells were injected into cadaveric tissue samples by either waterjet or injection needle. In other experiments, labeled cells were injected by waterjet in the urethra of living pigs and incubated for up to 7 days of follow-up. The analyses documented that the cells injected by waterjet in vitro were viable and proliferated well. Upon injection in live animals, cells appeared undamaged, showed defined cellular somata with distinct nuclei, and contained intact chromosomal DNA. Most importantly, by in vivo waterjet injections, a significantly wider cell distribution was observed when compared with needle injections (P < .05, n ≥ 12 samples). The success rates of waterjet cell application in living animals were significantly higher (≥95%, n = 24) when compared with needle injections, and the injection depth of cells in the urethra could be adapted to the need by adjusting waterjet pressures. We conclude that the novel waterjet technology injects viable muscle cells in tissues at distinct and predetermined depth depending on the injection pressure employed. After waterjet injection, loss of cells by full penetration or injury of the tissue targeted was reduced significantly in comparison with our previous studies employing needle injections.

Intraperitoneal extension of the peritoneal dialysis catheter-a new technique for catheter implantation in patients with obesity.

BACKGROUND: In patients with obesity and end-stage kidney disease, implantation of the peritoneal dialysis (PD) catheter may be complicated by increased abdominal circumference or skin folds. Relocation of the implantation site to the upper abdomen could solve this problem. However, this would require an extended catheter. METHODS: We developed an extended PD catheter based on a swan neck Missouri PD catheter with the help of two adaptors and a straight intraperitoneal extension segment. The extended catheter was assembled intraoperatively, and its length was adjusted individually to ensure correct positioning. After the operation, PD was commenced and handled as usual. RESULTS: In the period from 2011 to 2021, we implanted 31 extended PD catheters in 29 patients (38% men) with end-stage renal failure and obesity. Median age was 53 (range 28-77) years and body mass index was 35.5 (range 26.4-46.9) kg/m2. The postoperative course was unremarkable except for seroma formation in one patient and dialysate leakage in another. Continuous ambulatory peritoneal dialysis (CAPD) was initiated in 20 and APD in 9 patients. The achieved median Kt/V was 2.10 (range 1.50-3.10). During the follow-up period lasting up to 51 months, there was one case of intraperitoneal catheter disconnection due to an avoidable handling error. The peritonitis rate was 1:40 months. The 1- and 2-year catheter survival was 92% and 67%, respectively, and paralleled patient survival. CONCLUSIONS: When using a PD catheter with an intraperitoneal extension, PD catheter implantation can be relocated to the upper abdomen in patients with obesity, thus providing optimal position and easy surgical access.

Investigation of Crystallization and Relaxation Effects in Coarse-Grained Polyethylene Systems after Uniaxial Stretching.

In this study, we investigate the thermo-mechanical relaxation and crystallization behavior of polyethylene using mesoscale molecular dynamics simulations. Our models specifically mimic constraints that occur in real-life polymer processing: After strong uniaxial stretching of the melt, we quench and release the polymer chains at different loading conditions. These conditions allow for free or hindered shrinkage, respectively. We present the shrinkage and swelling behavior as well as the crystallization kinetics over up to 600 ns simulation time. We are able to precisely evaluate how the interplay of chain length, temperature, local entanglements and orientation of chain segments influences crystallization and relaxation behavior. From our models, we determine the temperature dependent crystallization rate of polyethylene, including crystallization onset temperature.

Safety and effectiveness of a novel generator algorithm for bipolar vessel sealing: a randomised controlled chronic animal study.

BACKGROUND: Electrosurgical vessel sealers are gradually replacing conventional techniques such as ligation and clipping. Algorithms that control electrosurgical units (ESU), known as modes, are important for applications in different surgical disciplines. This chronic porcine animal study aimed to evaluate the safety and effectiveness of the novel thermoSEAL electrosurgical vessel sealing mode (TSM). The BiClamp® mode (BCM) of the renowned VIO® 300 D ESU served as control. BCM has been widely available since 2002 and has since been successfully used in many surgical disciplines. The TSM, for the novel VIO® 3 ESU, was developed to reduce sealing time and/or thermal lateral spread adjacent to the seal while maintaining clinical success rates. The primary aim of this study was to investigate the long-term and intraoperative seal quality of TSM. METHODS: The BiCision® device was used for vessel sealing with TSM and BCM in ten German Landrace pigs which underwent splenectomy and unilateral nephrectomy during the first intervention of the study. The seals were cut with the BiCision® knife. Ninety-nine arteries, veins and vascular bundles were chronically sealed for 5 or 21 days. Thereafter, during the second and terminal intervention of the study, 97 additional arteries and veins were sealed. The carotid arteries were used for histological evaluation of thermal spread. RESULTS: After each survival period, no long-term complications occurred with either mode. The intraoperative seal failure rates, i.e. vessel leaking or residual blood flow after the first sealing activation, were 2% with TSM versus 6% with BCM (p = 0.28). The sealing time was significantly shorter with TSM (3.5 ± 0.69 s vs. 7.3 ± 1.3 s, p < 0.0001). The thermal spread and burst pressure of arteries sealed with both modes were similar (p = 0.18 and p = 0.61) and corresponded to the histological evaluation. The measured tissue sticking parameter was rare with both modes (p = 0.33). Tissue charring did not occur. Regarding the cut quality, 97% of the seals were severed in the first and 3% in the second attempt (both with TSM and BCM). CONCLUSIONS: The novel TSM seals blood vessels twice as fast as the BCM while maintaining excellent tissue effect and clinical success rates. TRIAL REGISTRATION: Not applicable.

A real-time ex vivo model (eIBUB) for optimizing intraperitoneal drug delivery as an alternative to living animal models.

BACKGROUND: Optimization of intraperitoneal drug delivery systems requires functional models. We proposed the Inverted Bovine Urinary Bladder Model (IBUB), but IBUB does not allow repeated measurements over time and there is a significant biological variability between organs. METHODS: A further development of IBUB is presented, based on the physical principle of communicating vessels. Fresh bovine bladders were inverted so that the peritoneum lines up the inner surface. The IBUB and a second vessel were then interconnected under the same CO2 pressure and placed on two scales. The therapeutic solution (Doxorubicin 2.7 mg and Cisplatin 13.5 mg) was delivered via an aerosolizer. All experiments were in triplicate and blinded to the origin of samples, measurements in a GLP-certified laboratory. RESULTS: The enhanced IBUB (eIBUB) model allows measurements of tissue drug concentration, depth of tissue penetration and spatial distribution. The homogeneous morphology of the peritoneum enables standardized, multiple tissue sampling. eIBUB minimizes biological variability between different bladders and eliminates the bias caused by the liquid collecting at the bottom of the model. Concentration of doxorubicin in the eIBUB (mean ± STDV: 18.5 ± 22.6 ng/mg) were comparable to clinical peritoneal biopsies (19.2 ± 38.6 ng/mg), as was depth of drug penetration (eIBUB: mean (min-max) 433 (381-486) µm, clinical ~ 500 µm). CONCLUSIONS: The eIBUB model is a simple and powerful ex vivo model for optimizing intraperitoneal drug delivery and represents an attractive alternative to animal models. Results obtained are similar to those obtained in the human patient.

Automated closed-loop management of body temperature using forced-air blankets: preliminary feasibility study in a porcine model.

BACKGROUND: Management of a patient's body temperature is an important aspect of care that should be addressed by targeted temperature management (TTM). Often, non-invasive methods like forced-air blankets are used. Especially in the operating room this management may be a subsidiary and repetitive task requiring constant observation of the patient's body temperature and adaption using the limited set of available settings. Thus, automation of TTM is a feasible target to improve patient outcome and reduce caregiver workload. METHODS: A Philips IntelliVue MP 50 patient monitor with an arterial PiCCO catheter system was used to measure patient blood temperature. Thermal management was performed with a 3M Bair Hugger 755 warming unit with forced air blankets. The warming unit was extended by a computer interface to allow for remote and automated control. A proposed closed-loop algorithm reads the measured temperature and performs automated control of the 3M Bair Hugger. Evaluation was performed in an experimental intensive care setting for animal studies. Two fully automated trials are compared with two manual and two uncontrolled trials in the same study setting using six female pigs for prolonged observation times of up to 90 hours in each trial. RESULTS: The developed system and proposed algorithm allow more precise temperature management by keeping a set target temperature within a range of ± 0.5 °C in 88% of the observation time and within a range of ± 1.0 °C at all times. The proposed algorithm yielded better performance than did manual control or uncontrolled trials. It was able to adapt to individual patient needs as it is more dynamic than look-up table approaches with fixed settings for various temperatures. CONCLUSIONS: Closed-loop TTM using non-invasive forced-air warming blankets was successfully tested in a porcine study with the proposed hardware interface and control algorithm. This automation can be beneficial for patient outcome and can reduce caregiver workload and patient risk in clinical settings. As temperature readings are most often available, existing devices like the 3M Bair Hugger can easily be expanded. However, even if clinical application is feasible, open questions regarding approval and certification of such automated systems within the current legal situation still need to be answered.

Fully automated life support: an implementation and feasibility pilot study in healthy pigs.

BACKGROUND: Automated systems are available in various application areas all over the world for the purpose of reducing workload and increasing safety. However, such support systems that would aid caregivers are still lacking in the medical sector. With respect to workload and safety, especially, the intensive care unit appears to be an important and challenging application field. Whereas many closed-loop subsystems for single applications already exist, no comprehensive system covering multiple therapeutic aspects and interactions is available yet. This paper describes a fully closed-loop intensive care therapy and presents a feasibility analysis performed in three healthy pigs over a period of 72 h each to demonstrate the technical and practical implementation of automated intensive care therapy. METHODS: The study was performed in three healthy, female German Landrace pigs under general anesthesia with endotracheal intubation. An arterial and a central venous line were implemented, and a suprapubic urinary catheter was inserted. Electrolytes, glucose levels, acid-base balance, and respiratory management were completely controlled by an automated fuzzy logic system based on individual targets. Fluid management by adaption of the respective infusion rates for the individual parameters was included. RESULTS: During the study, no manual modification of the device settings was allowed or required. Homoeostasis in all animals was kept stable during the entire observation period. All remote-controlled parameters were maintained within physiological ranges for most of the time (free arterial calcium 73%, glucose 98%, arterial base excess 89%, and etCO2 98%). Subsystem interaction was analyzed. CONCLUSIONS: In the presented study, we demonstrate the feasibility of a fully closed-loop system, for which we collected high-resolution data on the interaction and response of the different subsystems. Further studies should use big data approaches to analyze and investigate the interactions between the subsystems in more detail.

Evaluation of a novel electrosurgical sealing mode in an ex vivo and in vivo porcine model.

BACKGROUND: Bipolar vessel sealing has been successfully introduced in a variety of procedures like prostatectomy, hysterectomy, and nephrectomy. In this study, we evaluated a new sealing mode-the thermoSEAL® mode (TSM)-operated with the VIO3 generator in an ex vivo and in vivo animal study and compared the results with the commercially available BiClamp mode (BCM), operated with the VIO300D generator. Two different instruments were used in combination with both modes, BiCision® and BiClamp® 201T (Erbe Elektromedizin GmbH). METHODS: In the ex vivo experiment, the sealing of renal arteries was evaluated using both instruments and modes. For the in vivo study, different types of arteries and veins were sealed using both modes and instruments in a side-by-side comparison for acute complications in a total of four animals. RESULTS: Mean burst pressure was in all cases significantly above 360 mmHg (p < 0.001). Sealing time during the ex vivo setting was significantly shorter for TSM compared to BCM: BiCision® (3.7 ± 0.4 vs. 7.1 ± 0.3 s; p < 0.0001); BiClamp® 201T (3.9 ± 0.3 vs. 5.1 ± 1.1 s; p < 0.0015). Lateral thermal damage was more pronounced for BCM: BiCision® (TSM 1.4 ± 0.3 mm vs. BCM 1.9 ± 0.2 mm; p < 0.0001); BiClamp® 201T (TSM 1.9 ± 0.6 mm vs. BCM 3.1 ± 0.6 mm; p < 0.0001). The sealing time during the in vivo study was significantly shorter for TSM in combination with BiCision® for arteries [TSM 3.0 ± 0.7 s vs. BCM 6.5 ± 1.3 s, (p < 0.0001) and veins 3.2 ± 1.1 vs. 5.8 ± 1.8 s, (p < 0.0001)]. No significant differences were seen for the two modes used with BiClamp® 201T [artery: TSM 3.3 ± 0.7 s vs. BCM 3.4 ± 0.9 s, (p = 0.891)]. High sealing rates for arteries (100%) and veins (>90%) were noted for both instruments and modes. CONCLUSIONS: While both modes used with two different instruments reveal high safety characterized by a high burst pressure, low thermal damage (ex vivo) zones, and high sealing rates (in vivo), the thermoSEAL® mode convinces by its fast sealing speed probably helping to reduce operation time.

Pathophysiological central nervous system changes in a porcine model of acetaminophen-induced acute liver failure.

BACKGROUND: Critical care management of patients suffering from acute liver failure (ALF) continues to be challenging. Animal models studying the pathophysiological central nervous system alterations during the course of ALF provide an opportunity to improve diagnostic and therapeutic strategies. The aim of this study was to analyse the course of cerebral oxygenation in addition to conventional neuromonitoring during the course of acetaminophen-induced ALF. METHODS: ALF was induced by intrajejunal acetaminophen administration in 20 German landrace pigs. All animals underwent invasive hemodynamic and neuromonitoring and were maintained under standardized intensive care support. Neuromonitoring consisted of continuous intraparenchymatous recording of intracranial pressure and brain partial oxygen pressure. Hemodynamic and ventilation parameters were continuously recorded; laboratory parameters were analysed every eight hours. Mean values were compared using the Wilcoxon test. RESULTS: Acute liver failure occurred in all intoxicated animals after 23±2h, resulting in death due to ALF after further 15±2h. Continuous neuromonitoring was performed in all animals during the whole experiment without observing signs of intracranial haemorrhage. Two hours after manifestation of ALF an increase in brain tissue oxygen (PtiO2) was observed. Brain oxygenation stayed stable until nine hours before death. Intracranial pressure (ICP) remained basically at a plateau level until manifestation of ALF. In the following ten hours a linear and slow increase was observed until five hours before death, followed by a fast and continuous rise in ICP to a final level of 35±1mmHg. Cerebral perfusion pressure (CPP) began to decrease 25h prior to exitus, further decreasing to 18±2mmHg at the end of the experiment. A strong negative linear correlation was found between PtiO2 and ICP (R=0.97). Arterial partial pressure of oxygen (PaO2) below 100mmHg was associated with lower PtiO2 levels. Changes in arterial partial pressure of carbon dioxide (PaC02) did not influence PtiO2 values. Hemoglobin values below 7g/dl were associated with lower PtiO2 values. CONCLUSIONS: The results of our experiments demonstrate that ICP and PtiO2 measurements indicate impending damage well before serious complications occur and their use should be considered in order to protect endangered brain function in the presence of acetaminophen-induced ALF.

Algorithm-based arterial blood sampling recognition increasing safety in point-of-care diagnostics.

AIM: To detect blood withdrawal for patients with arterial blood pressure monitoring to increase patient safety and provide better sample dating. METHODS: Blood pressure information obtained from a patient monitor was fed as a real-time data stream to an experimental medical framework. This framework was connected to an analytical application which observes changes in systolic, diastolic and mean pressure to determine anomalies in the continuous data stream. Detection was based on an increased mean blood pressure caused by the closing of the withdrawal three-way tap and an absence of systolic and diastolic measurements during this manipulation. For evaluation of the proposed algorithm, measured data from animal studies in healthy pigs were used. RESULTS: Using this novel approach for processing real-time measurement data of arterial pressure monitoring, the exact time of blood withdrawal could be successfully detected retrospectively and in real-time. The algorithm was able to detect 422 of 434 (97%) blood withdrawals for blood gas analysis in the retrospective analysis of 7 study trials. Additionally, 64 sampling events for other procedures like laboratory and activated clotting time analyses were detected. The proposed algorithm achieved a sensitivity of 0.97, a precision of 0.96 and an F1 score of 0.97. CONCLUSION: Arterial blood pressure monitoring data can be used to perform an accurate identification of individual blood samplings in order to reduce sample mix-ups and thereby increase patient safety.