Experimental Pain and Auditory Sensitivity in Overactive Bladder Syndrome: A Symptoms of the Lower Urinary Tract Dysfunction Research Network (LURN) Study.

PURPOSE: The objective of this study was to investigate the presence of nonbladder sensory abnormalities in participants with overactive bladder syndrome (OAB). MATERIALS AND METHODS: Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) study participants with OAB symptoms and controls were recruited from 6 U.S. tertiary referral centers. Quantitative sensory testing (QST) was performed to determine pressure pain sensitivity at the thumbnail bed and auditory sensitivity. Fixed and mixed effect multivariable linear regressions and Weibull models were used to compare QST responses between groups. Pearson correlations were used to assess the relationship between QST measures. Associations between QST and self-reported symptoms were explored with linear regression. RESULTS: A total of 297 participants were analyzed (191 OAB, 106 controls; 76% white, 51% male). OAB cases were older than controls (57.4 vs 52.2 years, p=0.015). No significant differences in experimental thumbnail (nonbladder) pain or auditory sensitivity were detected between OAB cases and controls. Correlations between pressure and auditory derived metrics were weak to moderate overall for both groups, with some significantly stronger correlations for cases. Exploratory analyses indicated increased pressure pain and auditory sensitivity were modestly associated with greater self-reported bladder pain and pain interference with physical function. CONCLUSIONS: As a group, no significant differences between OAB cases and controls were observed in experimental nonbladder pain or auditory sensitivity during QST. Associations between QST outcomes and clinical pain raise the possibility of centrally mediated sensory amplification in some individuals with OAB.

Influence of non-invasive blood pressure measurement intervals on the occurrence of intra-operative hypotension.

The American Society of Anesthesiologists Standards for Basic Monitoring recommends blood pressure (BP) measurement every 5 min. Research has shown distractions or technical factors can cause prolonged measurement intervals exceeding 5 min. We investigated the relationship between prolonged non-invasive BP (NIBP) measurement interval and the incidence of hypotension, detected post-interval. Our secondary outcome was to determine independent predictors of these prolonged NIBP measurement intervals. Retrospective data were analyzed from 139,509 general anesthesia cases from our institution's Anesthesia Information Management System (AIMS). Absolute hypotension (AH) was defined a priori as a systolic BP < 80 mmHg and relative hypotension (RH) was defined as a 40% decrease in systolic BP from the preoperative baseline. Odds ratios (OR) with 95% confidence intervals and Pearson's Chi square Test reported the association of prolonged NIBP measurement intervals on hypotension detected post-NIBP measurement interval. Logistic regression models were developed to determine independent predictors of NIBP measurement intervals. The analysis revealed that NIBP measurement intervals greater than 6 and 10 min are associated with an approximately four times higher incidence of a patient transitioning into hypotension (AH/RH > 6 min OR 4.0 / 3.6; AH/RH > 10 min OR 4.3 / 3.9; p < 0.001). A key finding was that the "> 10-minute AH model" indicated that age 41-80, increased co-morbidity profile, obesity and turning (repositioning) of the operative room table were significant predictors of prolonged NIBP measurement intervals (p < 0.001). While we do not suggest NIBP measurement intervals cause hypotension, intervals greater than 6 and 10 min are associated with a fourfold increase in the propensity of an undetected transition into both RH or AH. These data support current monitoring guidelines.

The use of portable ultrasound devices in low- and middle-income countries: a systematic review of the literature.

OBJECTIVES: To review the scientific literature pertaining to the use of hand-carried and hand-held ultrasound devices in low- and middle-income countries (LMIC), with a focus on clinical applications, geographical areas of use, the impact on patient management and technical features of the devices used. METHODS: The electronic databases PubMed and Google Scholar were searched. No language or date restrictions were applied. Case reports and original research describing the use of hand-carried ultrasound devices in LMIC were included if agreed upon as relevant by two-reviewer consensus based on our predefined research questions. RESULTS: A total of 644 articles were found and screened, and 36 manuscripts were included for final review. Twenty-seven studies were original research articles, and nine were case reports. Several reports describe the successful diagnosis and management of difficult, often life-threatening conditions, using hand-carried and hand-held ultrasound. These portable ultrasound devices have also been studied for cardiac screening exams, as well as a rapid triage tool in rural areas and after natural disaster. Most applications focus on obstetrical and abdominal complaints. Portable ultrasound may have an impact on clinical management in up to 70% of all cases. However, no randomised controlled trials have evaluated the impact of ultrasound-guided diagnosis and treatment in resource-constrained settings. The exclusion of articles published in journals not listed in the large databases may have biased our results. Our findings are limited by the lack of higher quality evidence (e.g. controlled trials). CONCLUSIONS: Hand-carried and hand-held ultrasound is successfully being used to triage, diagnose and treat patients with a variety of complaints in LMIC. However, the quality of the current evidence is low. There is an urgent need to perform larger clinical trials assessing the impact of hand-carried ultrasound in LMIC.

Quantitative lung ultrasound comet measurement: method and initial clinical results.

BACKGROUND/AIMS: Recently, ultrasound signals termed 'lung water comets' associated with pulmonary edema have been correlated with adverse clinical events in dialysis patients. These comets fluctuate substantially during the ultrasound exam highlighting the need for objective quantitative measurement methods. METHODS: We developed an image-processing algorithm for the detection and quantification of lung comets. Quantification measures included comet number (comet count) and the fraction of the ultrasound beams with comet findings (comet fraction). We used this algorithm in a pilot study in 20 stable dialysis outpatients to identify associations between ultrasound comets and clinical parameters including blood pressure (BP), percent blood volume reduction on dialysis (%BV), ejection fraction (EF), and ultrafiltration on dialysis (UF). RESULTS: Positive findings included associations with lung comet measurements with pre-dialysis Diastolic BP (r = 0.534, p = 0.015), subject age (r = -0.446, p = 0.049), and a combination of EF and end dialysis %BV reduction (r = -0.585, p = 0.028). Comet fraction and comet count were closely correlated due to the inherent relationship between these two metrics (r = 0.973, p < 0.001). Negative findings included ultrasound comets that did not change from beginning to end of dialysis (p = 0.756), and were not significantly correlated with single dialysis treatment UF (p = 0.522), subject body weight (p = 0.208), or BMI (p = 0.358). CONCLUSIONS: Ultrasound signal processing methods may help quantify lung ultrasound comets. Additional findings include algorithmic lung comet measurement that did not change significantly during single dialysis sessions in these stable outpatients, but were associated with cardiovascular and fluid status parameters.

Quantification of ultrasound correlation-based flow velocity mapping and edge velocity gradient measurement.

This study investigated the use of ultrasound speckle decorrelation- and correlation-based lateral speckle-tracking methods for transverse and longitudinal blood velocity profile measurement, respectively. By studying the blood velocity gradient at the vessel wall, vascular wall shear stress, which is important in vascular physiology as well as the pathophysiologic mechanisms of vascular diseases, can be obtained. Decorrelation-based blood velocity profile measurement transverse to the flow direction is a novel approach, which provides advantages for vascular wall shear stress measurement over longitudinal blood velocity measurement methods. Blood flow velocity profiles are obtained from measurements of frame-to-frame decorrelation. In this research, both decorrelation and lateral speckle-tracking flow estimation methods were compared with Poiseuille theory over physiologic flows ranging from 50 to 1000 mm/s. The decorrelation flow velocity measurement method demonstrated more accurate prediction of the flow velocity gradient at the wall edge than the correlation-based lateral speckle-tracking method. The novelty of this study is that speckle decorrelation-based flow velocity measurements determine the blood velocity across a vessel. In addition, speckle decorrelation-based flow velocity measurements have higher axial spatial resolution than Doppler ultrasound measurements to enable more accurate measurement of blood velocity near a vessel wall and determine the physiologically important wall shear.

Computational modeling and prototyping of a pediatric airway management instrument.

BACKGROUND: Anterior retraction of the tongue is used to enhance upper airway patency during pediatric fiberoptic intubation. This can be achieved by the use of Magill forceps as a tongue retractor, but lingual grip can become unsteady and traumatic. Our objective was to modify this instrument using computer-aided engineering for the purpose of stable tongue retraction. METHODS: We analyzed the geometry and mechanical properties of standard Magill forceps with a combination of analytical and empirical methods. This design was captured using computer-aided design techniques to obtain a 3-dimensional model allowing further geometric refinements and mathematical testing for rapid prototyping. RESULTS: On the basis of our experimental findings we adjusted the design constraints to optimize the device for tongue retraction. Stereolithography prototyping was used to create a partially functional plastic model to further assess the functional and ergonomic effectiveness of the design changes. To reduce pressure on the tongue by regular Magill forceps, we incorporated (1) a larger diameter tip for better lingual tissue pressure profile, (2) a ratchet to stabilize such pressure, and (3) a soft molded tip with roughened surface to improve grip. CONCLUSION: Computer-aided engineering can be used to redesign and prototype a popular instrument used in airway management. On a computational model, our modified Magill forceps demonstrated stable retraction forces, while maintaining the original geometry and versatility. Its application in humans and utility during pediatric fiberoptic intubation are yet to be studied.

Arterial elasticity imaging: comparison of finite-element analysis models with high-resolution ultrasound speckle tracking.

BACKGROUND: The nonlinear mechanical properties of internal organs and tissues may be measured with unparalleled precision using ultrasound imaging with phase-sensitive speckle tracking. The many potential applications of this important noninvasive diagnostic approach include measurement of arterial stiffness, which is associated with numerous major disease processes. The accuracy of previous ultrasound measurements of arterial stiffness and vascular elasticity has been limited by the relatively low strain of nonlinear structures under normal physiologic pressure and the measurement assumption that the effect of the surrounding tissue modulus might be ignored in both physiologic and pressure equalized conditions. METHODS: This study performed high-resolution ultrasound imaging of the brachial artery in a healthy adult subject under normal physiologic pressure and the use of external pressure (pressure equalization) to increase strain. These ultrasound results were compared to measurements of arterial strain as determined by finite-element analysis models with and without a surrounding tissue, which was represented by homogenous material with fixed elastic modulus. RESULTS: Use of the pressure equalization technique during imaging resulted in average strain values of 26% and 18% at the top and sides, respectively, compared to 5% and 2%, at the top and sides, respectively, under physiologic pressure. In the artery model that included surrounding tissue, strain was 19% and 16% under pressure equalization versus 9% and 13% at the top and sides, respectively, under physiologic pressure. The model without surrounding tissue had slightly higher levels of strain under physiologic pressure compared to the other model, but the resulting strain values under pressure equalization were > 60% and did not correspond to experimental values. CONCLUSIONS: Since pressure equalization may increase the dynamic range of strain imaging, the effect of the surrounding tissue on strain should be incorporated into models of arterial strain, particularly when the pressure equalization technique is used.

Pressure Pain Tolerance Predicts the Success of Emotional Awareness and Expression Therapy in Patients With Fibromyalgia.

OBJECTIVES: Quantitative sensory testing may help predict treatment responses in individuals with chronic pain. Our objective was to determine whether evoked pain sensitivity at baseline predicted preferential treatment responses to either emotional awareness and expression therapy (EAET) or cognitive behavioral therapy (CBT) in individuals with fibromyalgia (FM). METHODS: This was a secondary analysis of a previous randomized clinical trial, in which individuals with FM were randomized to EAET, CBT, or Education as a control intervention. Only females who completed baseline and post-treatment assessments were analyzed (n=196). The primary outcome was change in overall clinical pain severity from pretreatment to posttreatment, and the primary predictor of interest was pressure pain tolerance at baseline. RESULTS: Among patients with low pain tolerance at baseline (n=154), both EAET and CBT led to small but significant improvements in clinical pain severity (CBT mean=0.66, 95% confidence interval [0.24-1.07]; EAET mean=0.76 [0.34-1.17]). Conversely, in patients with normal pain tolerance (n=42), there was no significant improvement in clinical pain after CBT (0.13 [-0.88 to 1.14]), a small improvement after FM Education (0.81 [0.14-1.48]), but a much larger and statistically significant improvement after EAET (2.14 [1.23-3.04]). DISCUSSION: Normal levels of pressure pain tolerance at baseline predicted greater improvement in clinical pain severity after EAET than CBT. Quantitative sensory testing may provide insights about individual responses to psychologically based therapies for individuals with chronic pain.

Specificity improvement for network distributed physiologic alarms based on a simple deterministic reactive intelligent agent in the critical care environment.

Automated physiologic alarms are available in most commercial physiologic monitors. However, due to the variability of data coming from the physiologic sensors describing the state of patients, false positive alarms frequently occur. Each alarm requires review and documentation, which consumes clinicians' time, may reduce patient safety through 'alert fatigue' and makes automated physician paging infeasible. To address these issues a computerized architecture based on simple reactive intelligent agent technology has been developed and implemented in a live critical care unit to facilitate the investigation of deterministic algorithms for the improvement of the sensitivity and specificity of physiologic alarms. The initial proposed algorithm uses a combination of median filters and production rules to make decisions about what alarms to generate. The alarms are used to classify the state of patients and alerts can be easily viewed and distributed using standard network, SQL database and Internet technologies. To evaluate the proposed algorithm, a 28 day study was conducted in the University of Michigan Medical Center's 14 bed Cardiothoracic Intensive Care Unit. Alarms generated by patient monitors, the intelligent agent and alerts documented on patient flow sheets were compared. Significant improvements in the specificity of the physiologic alarms based on systolic and mean blood pressure was found on average to be 99% and 88% respectively. Even through significant improvements were noted based on this algorithm much work still needs to be done to ensure the sensitivity of alarms and methods to handle spurious sensor data due to patient or sensor movement and other influences.

Bimodal classification algorithm for atrial fibrillation detection from m-health ECG recordings.

INTRODUCTION: Atrial Fibrillation (AF) is the most common cardiac arrhythmia, presenting a significant independent risk factor for stroke and thromboembolism. With the emergence of m-Health devices, the importance of automatic detection of AF in an off-clinic setting is growing. This study demonstrates the performance of a bimodal classifier for distinguishing AF from sinus rhythm (SR) that could be used for automated detection of AF episodes. METHODS: Surface recordings from a hand-held research device and standard electrocardiograms (ECG) were collected and analyzed from 68 subjects. An additional 48 subjects from the MIT-BIH Arrythmia Database were also analyzed. All ECGs were blindly reviewed by physicians independently of the bimodal algorithm analysis. The algorithm selects an artifact-free 6-s ECG segment out of a 20-s long recording and computes a spectral Frequency Dispersion Metric (FDM) and a temporal R-R interval variability (VRR) index. RESULTS: Scatter plots of the VRR and FDM indices revealed two distinct clusters. The bimodal scattering of the indices revealed a linear classification boundary that could be employed to differentiate the SR from AF waveforms. The selected classification boundary was able to correctly differentiate all the subjects from both datasets into either SR or AF groups, except for 3 SR subjects from the MIT-BIH dataset. CONCLUSION: Our bimodal classification algorithm was demonstrated to successfully acquire, analyze and interpret ECGs for the presence of AF indicating its potential to support m-Health diagnosis, monitoring, and management of therapy in AF patients.

Quantitative assessment of nonpelvic pressure pain sensitivity in urologic chronic pelvic pain syndrome: a MAPP Research Network study.

Experimental pain sensitivity was assessed in individuals with urologic chronic pelvic pain syndrome (UCPPS) as part of the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network. A series of computer-controlled pressure stimuli were delivered to the thumbnail bed, an asymptomatic site distant from the area of UCPPS pain that is considered to be indicative of overall body pain threshold. Stimuli were rated according to a standardized magnitude estimation protocol. Pain sensitivity in participants with UCPPS was compared with healthy controls and a mixed pain group composed of individuals with other chronic overlapping pain conditions, including fibromyalgia, chronic fatigue, and irritable bowel syndromes. Data from 6 participating MAPP testing sites were pooled for analysis. Participants with UCPPS (n = 153) exhibited an intermediate pain sensitivity phenotype: they were less sensitive relative to the mixed pain group (n = 35) but significantly more sensitive than healthy controls (n = 100). Increased pain sensitivity in patients with UCPPS was associated with both higher levels of clinical pain severity and more painful body areas outside the pelvic region. Exploratory analyses in participants with UCPPS revealed that pain sensitivity increased during periods of urologic symptom flare and that less pressure pain sensitivity at baseline was associated with a greater likelihood of subsequent genitourinary pain improvement 1 year later. The finding that individuals with UCPPS demonstrate nonpelvic pain hypersensitivity that is related to clinical symptoms suggests that central nervous system mechanisms of pain amplification contribute to UCPPS.

Applications of sensory and physiological measurement in oral-facial dental pain.

Dentists regularly employ a variety of self-report and sensory techniques to aid in the diagnosis and treatment of tooth-related disease. Many of these techniques leverage principles borrowed from psychophysics, the quantitative measurement of the relationship between stimuli and evoked sensations, which falls under the larger umbrella of quantitative sensory testing (QST). However, most clinicians fail to meet the bar for what could be considered quantitative sensory testing, and instead focus on qualitative and dichotomous "yes/no" aspects of sensory experience. With our current subjective measurements for pain assessments, diagnosis and treatment of dental pain in young children and individuals (any age) with severe cognitive impairment rely extensively on third-party observations. Consequently, the limitation of inadequate pain diagnosis can lead to poor pain management. In this review, it discusses mechanisms that underlie acute and chronic dental pain. It details the measurement of somatosensory responses and pulpal blood flow as objective measures of tooth health and pain. It proposes that bridging these varied methodologies will significantly improve diagnosis and treatment of orofacial pain and pathology. It concludes that improving the precision of sensory measurements could yield important improvements in diagnostic challenges in pulpal pathology for noncommunicative and cognitively impaired individuals.

Accurate pain reporting training diminishes the placebo response: Results from a randomised, double-blind, crossover trial.

Analgesic trials frequently fail to demonstrate efficacy of drugs known to be efficacious. Poor pain reporting accuracy is a possible source for this low essay-sensitivity. We report the effects of Accurate-Pain-Reporting-Training (APRT) on the placebo response in a trial of Pregabalin for painful-diabetic-neuropathy. The study was a two-stage randomized, double-blind trial: In Stage-1 (Training) subjects were randomized to APRT or No-Training. The APRT participants received feedback on the accuracy of their pain reports in response to mechanical stimuli, measured by R-square score. In Stage-2 (Evaluation) all subjects entered a placebo-controlled, cross-over trial. Primary (24-h average pain intensity) and secondary (current, 24-h worst, and 24-h walking pain intensity) outcome measures were reported. Fifty-one participants completed the study. APRT patients (n = 28) demonstrated significant (p = 0.036) increases in R-square scores. The APRT group demonstrated significantly (p = 0.018) lower placebo response (0.29 ± 1.21 vs. 1.48 ± 2.21, mean difference ± SD = -1.19±1.73). No relationships were found between the R-square scores and changes in pain intensity in the treatment arm. In summary, our training successfully increased pain reporting accuracy and resulted in a diminished placebo response. Theoretical and practical implications are discussed.

Design and Testing of a Single-Element Ultrasound Viscoelastography System for Point-of-Care Edema Quantification.

Management of fluid overload in patients with end-stage renal disease represents a unique challenge to clinical practice because of the lack of accurate and objective measurement methods. Currently, peripheral edema is subjectively assessed by palpation of the patient's extremities, ostensibly a qualitative indication of tissue viscoelastic properties. New robust quantitative estimates of tissue fluid content would allow clinicians to better guide treatment, minimizing reactive treatment decision making. Ultrasound viscoelastography (UVE) can be used to estimate strain in viscoelastic tissue, deriving material properties that can help guide treatment. We are developing and testing a simple, low-cost UVE system using a single-element imaging transducer that is simpler and less computationally demanding than array-based systems. This benchtop validation study tested the feasibility of using the UVE system by measuring the mechanical properties of a tissue-mimicking material under large strains. We generated depth-dependent creep curves and viscoelastic parameter maps of time constants and elastic moduli for the Kelvin model of viscoelasticity. During testing, the UVE system performed well, with mean UVE-measured strain matching standard mechanical testing with maximum absolute errors ≤4%. Motion tracking revealed high correlation and signal-to-noise ratios, indicating that the system is reliable.

Design of Bioimpedance Spectroscopy Instrument With Compensation Techniques for Soft Tissue Characterization.

Bioimpedance spectroscopy (BIS) has shown significant potential in many areas of medicine to provide new physiologic markers. Several acute and chronic diseases are accompanied by changes in intra- and extracellular fluid within various areas of the human body. The estimation of fluid in various body compartments is therefore a simple and convenient method to monitor certain disease states. In this work, the design and evaluation of a BIS instrument are presented and three key areas of the development process investigated facilitating the BIS measurement of tissue hydration state. First, the benefit of incorporating DC-stabilizing circuitry to the standard modified Howland current pump (MHCP) is investigated to minimize the effect of DC offsets limiting the dynamic range of the system. Second, the influence of the distance between the bioimpedance probe and a high impedance material is investigated using finite element analysis (FEA). Third, an analytic compensation technique is presented to minimize the influence of parasitic capacitance. Finally, the overall experimental setup is evaluated through ex vivo BIS measurements of porcine spleen tissue and compared to published results. The DC-stabilizing circuit demonstrated its ability to maintain DC offsets at less than 650 µV through 100 kHz while maintaining an output impedance of 1 MΩ from 100 Hz to 100 kHz. The proximity of a bioimpedance probe to a high impedance material such as acrylic was shown to increase measured impedance readings by a factor of 4x as the ratio of the distance between the sensing electrodes to the distance between the bioimpedance probe and acrylic reached 1:3. The average parasitic capacitance for the circuit presented was found to be 712 ± 128 pF, and the analytic compensation method was shown to be able to minimize this effect on the BIS measurements. Measurements of porcine spleen tissue showed close correlation with experimental results reported in published articles. This research presents the successful design and evaluation of a BIS instrument. Specifically, robust measurements were obtained by implementing a DC-stabilized current source, investigating probe-material proximity issues and compensating for parasitic capacitance. These strategies were shown to provide tissue measurements comparable with published literature.

Development and validation of a pressure-type automated quantitative sensory testing system for point-of-care pain assessment.

Quantitative sensory testing (QST) can provide useful information about the underlying mechanisms involved in chronic pain. However, currently available devices typically employed suffer from operator-dependent effects, or are too cumbersome for routine clinical care. This paper presents the design and initial validation of a novel automated pressure-pain type QST platform, termed the multi-modal automated sensory testing (MAST) system. The MAST configuration presented consists of wireless, hand-held thumbnail pressure stimulators (with circular 10 mm² rubber tips) and graphical touch screen interface devices to manage the QST process and obtain patient feedback. Validation testing of the custom-designed force sensor showed a 1 % error for low forces increasing to 2 % error for larger loads up to 100 N (full-scale). Validation of the controller using three ramp rates (64, 248, and 496 kPa/s) and six pressures (32, 62, 124, 273, 620, and 1116 kPa) showed an overall mean error of 1.7 % for applied stimuli. Clinical evaluation revealed decreased pressure pain thresholds in chronic pain patients (98.07 ± SE 16.34 kPa) compared to pain free, healthy control subjects (259.88 ± SE 33.54 kPa, p = 0.001). The MAST system is portable and produces accurate, repeatable stimulation profiles indicating potential for point-of-care applications.

In vivo vascular wall shear rate and circumferential strain of renal disease patients.

This study measures the vascular wall shear rate at the vessel edge using decorrelation based ultrasound speckle tracking. Results for nine healthy and eight renal disease subjects are presented. Additionally, the vascular wall shear rate and circumferential strain during physiologic pressure, pressure equalization and hyperemia are compared for five healthy and three renal disease subjects. The mean and maximum wall shear rates were measured during the cardiac cycle at the top and bottom wall edges. The healthy subjects had significantly higher mean and maximum vascular wall shear rate than the renal disease subjects. The key findings of this research were that the mean vascular wall shear rates and circumferential strain changes between physiologic pressure and hyperemia that was significantly different between healthy and renal disease subjects.

Performance of Biopsy Needle With Therapeutic Injection System to Prevent Bleeding Complications.

Renal disease is epidemic in the United States with approximately 8 × 106 people having chronic kidney disease. Renal biopsies are widely used to provide essential diagnostic information to physicians. However, the risk of bleeding complications possibly leading to life-threatening situations results in the contra-indication of biopsy in certain patient populations. Safer renal biopsies will allow more accurate diagnosis and better management of this epidemic health problem. We report the preclinical testing of a novel biopsy device called the therapeutic injection system (TIS). The device introduces a third stage to the standard two-stage side-cut percutaneous biopsy process. The third stage is designed to reduce bleeding complications by injecting a hemostatic plug at the time of biopsy. Laboratory evaluation and preliminary in vivo animal testing using an anticoagulated porcine model of the TIS and Bard Monopty® (Bard Medical, Covington, GA) control device were performed. The hemostatic material Gelfoam® (Pfizer, Brussels, Belgium) was selected as the active material comprising the hemostatic plugs. The performance of two composite plugs, one composed of polyvinyl alcohol (PVA) combined in 2:1 and 12:1 ratios with the hemostatic material, and one plug composed of 100[Formula: see text] hemostatic material were tested. Stroke sequence and hemostatic plug deployment were verified by sequential firing of the TIS biopsy needle into clear gelatin and ex vivo bovine kidney specimens. In vivo trials with porcine specimens revealed a significant reduction in blood loss (8.1 [Formula: see text] 3.9 ml, control versus 1.9 [Formula: see text] 1.6 ml, 12:1 PVA/hemostatic, TIS, [Formula: see text] = 0.01, [Formula: see text] = 6). The 100[Formula: see text] hemostatic plug showed a substantial and immediate reduction in blood loss (9.2 ml, control versus 0.0 ml, TIS, [Formula: see text] = 1). The prototype device was shown to work repeatedly and reliably in laboratory trials. Initial results show promise in this approach to control post biopsy bleeding. This solution maintains the simplicity and directness of the percutaneous approach, while not significantly changing the standard percutaneous biopsy procedure.

Advanced integrated real-time clinical displays.

Intelligent medical displays have the potential to improve patient outcomes by integrating multiple physiologic signals, exhibiting high sensitivity and specificity, and reducing information overload for physicians. Research findings have suggested that information overload and distractions caused by patient care activities and alarms generated by multiple monitors in acute care situations, such as the operating room and the intensive care unit, may produce situations that negatively impact the outcomes of patients under anesthesia. This can be attributed to shortcomings of human-in-the-loop monitoring and the poor specificity of existing physiologic alarms. Modern artificial intelligence techniques (ie, intelligent software agents) are demonstrating the potential to meet the challenges of next-generation patient monitoring and alerting.