Non-invasive biomarkers for detecting progression toward hypovolemic cardiovascular instability in a lower body negative pressure model.

Occult hemorrhages after trauma can be present insidiously, and if not detected early enough can result in patient death. This study evaluated a hemorrhage model on 18 human subjects, comparing the performance of traditional vital signs to multiple off-the-shelf non-invasive biomarkers. A validated lower body negative pressure (LBNP) model was used to induce progression towards hypovolemic cardiovascular instability. Traditional vital signs included mean arterial pressure (MAP), electrocardiography (ECG), plethysmography (Pleth), and the test systems utilized electrical impedance via commercial electrical impedance tomography (EIT) and multifrequency electrical impedance spectroscopy (EIS) devices. Absolute and relative metrics were used to evaluate the performance in addition to machine learning-based modeling. Relative EIT-based metrics measured on the thorax outperformed vital sign metrics (MAP, ECG, and Pleth) achieving an area-under-the-curve (AUC) of 0.99 (CI 0.95-1.00, 100% sensitivity, 87.5% specificity) at the smallest LBNP change (0-15 mmHg). The best vital sign metric (MAP) at this LBNP change yielded an AUC of 0.6 (CI 0.38-0.79, 100% sensitivity, 25% specificity). Out-of-sample predictive performance from machine learning models were strong, especially when combining signals from multiple technologies simultaneously. EIT, alone or in machine learning-based combination, appears promising as a technology for early detection of progression toward hemodynamic instability.

Rapid patient-specific FEM meshes from 3D smart-phone based scans.

Objective.The objective of this study was to describe and evaluate a smart-phone based method to rapidly generate subject-specific finite element method (FEM) meshes. More accurate FEM meshes should lead to more accurate thoracic electrical impedance tomography (EIT) images.Approach.The method was evaluated on an iPhone®that utilized an app called Heges, to obtain 3D scans (colored, surface triangulations), a custom belt, and custom open-source software developed to produce the subject-specific meshes. The approach was quantitatively validated via mannequin and volunteer tests using an infrared tracker as the gold standard, and qualitatively assessed in a series of tidal-breathing EIT images recorded from 9 subjects.Main results.The subject-specific meshes can be generated in as little as 6.3 min, which requires on average 3.4 min of user interaction. The mannequin tests yielded high levels of precision and accuracy at 3.2 ± 0.4 mm and 4.0 ± 0.3 mm root mean square error (RMSE), respectively. Errors on volunteers were only slightly larger (5.2 ± 2.1 mm RMSE precision and 7.7 ± 2.9 mm RMSE accuracy), illustrating the practical RMSE of the method.Significance.Easy-to-generate, subject-specific meshes could be utilized in the thoracic EIT community, potentially reducing geometric-based artifacts and improving the clinical utility of EIT.

Estimating tongue deformation during laryngoscopy using a hybrid FEM-multibody model and intraoperative tracking - a cadaver study.

Throat tumour margin control remains difficult due to the tight, enclosed space of the oral and throat regions and the tissue deformation resulting from placement of retractors and scopes during surgery. Intraoperative imaging can help with better localization but is hindered by non-image-compatible surgical instruments, cost, and unavailability. We propose a novel method of using instrument tracking and FEM-multibody modelling to simulate soft tissue deformation in the intraoperative setting, without requiring intraoperative imaging, to improve surgical guidance accuracy. We report our first empirical study, based on four trials of a cadaveric head specimen with full neck anatomy, yields a mean TLE of 10.8 ± 5.5 mm, demonstrating methodological feasibility.

Development of an Electrical Impedance Tomography Coupled Surgical Stapler for Tissue Characterization.

OBJECTIVE: This study explores the feasibility of coupling Electrical Impedance Tomography (EIT) to a standard-of-care laparoscopic surgical stapler, stapler+EIT, with the long-term goal of enabling intraoperative tissue differentiation for tumor margin detection. METHODS: Two custom printed-circuit-board-based electrode arrays with 60 and 8 electrodes, respectively, matching the stapler geometry, served as the jaws of an electrode-integrated surrogate stapler+EIT device. The device was evaluated through a series of simulations and bench-top imaging experiments of agar-gel phantoms and bovine tissue samples to evaluate the technique and determine optimal imaging parameters. RESULTS: Electrodes localized to only one jaw (the 60-electrode side) of the stapler outperformed a dual-jaw distribution of electrodes. Using this one-sided electrode array, reconstructions achieved an Area-Under-the-Curve (AUC) ≥ 0.94 for inclusions with conductivity contrasts of ≥30% for any size considered on measured agar-gel tests, and an AUC of 0.80 for bovine tissue samples. CONCLUSION: A stapler+EIT algorithm has been tuned and evaluated on challenging phantom tests and demonstrated to produce accurate reconstructions. SIGNIFICANCE: This work is an important step in the development of a surgical stapler+EIT technique for margin assessment.

Towards intraoperative surgical margin assessment: Validation of an electrical impedance-based probe with ex vivo bovine tissue.

Radical prostatectomy (RP) is a common surgical therapy to treat prostate cancer. The procedure has a high positive surgical margin (PSM) rate ranging from 4-48%. Patients with PSMs have a higher rate of cancer recurrence and often undergo noxious adjuvant therapy. Intraoperative surgical margin assessment (SMA) with an electrical impedance-based probe can potentially identify PSMs in real-time. This would enable surgeons to make data-based decisions in the operating room to improve patient outcomes. This paper focuses on characterizing an impedance sensing SMA probe with specialized electrodes to improve speed and bandwidth while maintaining accuracy. 3D electrical impedance tomography (EIT) reconstructions were generated from ex vivo bovine tissue to characterize probe imaging and to determine an optimal applied pressure range (15 Pa to 38 Pa). Classification accuracy of adipose and muscle tissue was evaluated by comparing the experimental data set to simulated data based on a ground truth binary map of the tissue. Experimental AUCs ≥0.83 were maintained up to 50 kHz. The developed impedance sensing probe successfully classified between muscle and adipose tissue in an ex vivo bovine model. Future work includes improving performance of the SMA probe with custom hardware and collecting data from ex vivo and in vivo prostatic tissues.Clinical Relevance-This technology is expected to reduce the rate of PSMs in RP and decrease the use of post-surgical adjuvant therapies. It is also anticipated that intraoperative impedance measurements will increase efficacy of nerve sparing procedures and reduce complications such as incontinence and erectile dysfunction.

Brain responses to food viewing in women during pregnancy and post partum and their relationship with metabolic health: study protocol for the FOODY Brain Study, a prospective observational study.

INTRODUCTION: Food cravings are common in pregnancy and along with emotional eating and eating in the absence of hunger, they are associated with excessive weight gain and adverse effects on metabolic health including gestational diabetes mellitus (GDM). Women with GDM also show poorer mental health, which further can contribute to dysregulated eating behaviour. Food cravings can lead to greater activity in brain centres known to be involved in food 'wanting' and reward valuation as well as emotional eating. They are also related to gestational weight gain. Thus, there is a great need to link implicit brain responses to food with explicit measures of food intake behaviour, especially in the perinatal period. The aim of this study is to investigate the spatiotemporal brain dynamics to visual presentations of food in women during pregnancy and in the post partum, and link these brain responses to the eating behaviour and metabolic health outcomes in women with and without GDM. METHODS AND ANALYSIS: This prospective observational study will include 20 women with and 20 without GDM, that have valid data for the primary outcomes. Data will be assessed at 24-36 weeks gestational age and at 6 months post partum. The primary outcomes are brain responses to food pictures of varying carbohydrate and fat content during pregnancy and in the post partum using electroencephalography. Secondary outcomes including depressive symptoms, current mood and eating behaviours will be assessed with questionnaires, objective eating behaviours will be measured using Auracle and stress will be measured with heart rate and heart rate variability (Actiheart). Other secondary outcome measures include body composition and glycaemic control parameters. ETHICS AND DISSEMINATION: The Human Research Ethics Committee of the Canton de Vaud approved the study protocol (2021-01976). Study results will be presented at public and scientific conferences and in peer-reviewed journals.

Bioimpedance Sensing Surgical Drill - In Vivo Porcine Model.

Surgical drilling to place dental implants in the mandible and maxilla is associated high risk of iatrogenic injuries to inferior alveolar nerve and maxillary sinus. Real-time tissue margin sensing at the drill-tip using electrical impedance spectroscopy (EIS) could reduce this risk by providing feedback to surgeons. Studies with saline analogues, ex-vivo tissues, in-situ tissues and computer models have been previously conducted to evaluate these impedance sensors. Understanding in-vivo electrical properties of tissues in the mandible and maxilla is critical to further develop the sensor and tissue margin sensing algorithms. In this paper, we propose an in-vivo animal model using pigs and discuss methods to test the sensor. Intra-operative imaging and optical tracking systems to assist in surgical navigation are described. The process of registering imaging and tracking information to localize impedance measurement sites within the anatomy are detailed. Results from one in-vivo case of drilling through the mandible are presented and discussed. Clinical Relevance- This model is crucial for characterizing in-vivo electrical properties of mandibular and maxillary tissues encountered during dental implant surgical drilling and for translating bioimpedance sensing drill technology to clinical space.

Detection of subclinical hemorrhage using electrical impedance: a porcine study.

Objective.Analyze the performance of electrical impedance tomography (EIT) in an innovative porcine model of subclinical hemorrhage and investigate associations between EIT and hemodynamic trends.Approach. Twenty-five swine were bled at slow rates to create an extended period of subclinical hemorrhage during which the animal's heart rate (HR) and blood pressure (BP) remained stable from before hemodynamic deterioration, where stable was defined as <15% decrease in BP and <20% increase in HR-i.e.hemorrhages were hidden from standard vital signs of HR and BP. Continuous vital signs, photo-plethysmography, and continuous non-invasive EIT data were recorded and analyzed with the objective of developing an improved means of detecting subclinical hemorrhage-ideally as early as possible.Main results. Best area-under-the-curve (AUC) values from comparing bleed to no-bleed epochs were 0.96 at a 80 ml bleed (∼15.4 min) using an EIT-data-based metric and 0.79 at a 120 ml bleed (∼23.1 min) from invasively measured BP-i.e.the EIT-data-based metric achieved higher AUCs at earlier points compared to standard clinical metrics without requiring image reconstructions.Significance.In this clinically relevant porcine model of subclinical hemorrhage, EIT appears to be superior to standard clinical metrics in early detection of hemorrhage.

A particle filter approach to dynamic kidney pose estimation in robotic surgical exposure.

PURPOSE: Traditional soft tissue registration methods require direct intraoperative visualization of a significant portion of the target anatomy in order to produce acceptable surface alignment. Image guidance is therefore generally not available during the robotic exposure of structures like the kidneys which are not immediately visualized upon entry into the abdomen. This paper proposes guiding surgical exposure with an iterative state estimator that assimilates small visual cues into an a priori anatomical model as exposure progresses, thereby evolving pose estimates for the occluded structures of interest. METHODS: Intraoperative surface observations of a right kidney are simulated using endoscope tracking and preoperative tomography from a representative robotic partial nephrectomy case. Clinically relevant random perturbations of the true kidney pose are corrected using this sequence of observations in a particle filter framework to estimate an optimal similarity transform for fitting a patient-specific kidney model at each step. The temporal response of registration error is compared against that of serial rigid coherent point drift (CPD) in both static and simulated dynamic surgical fields, and for varying levels of observation persistence. RESULTS: In the static case, both particle filtering and persistent CPD achieved sub-5 mm accuracy, with CPD processing observations 75% faster. Particle filtering outperformed CPD in the dynamic case under equivalent computation times due to the former requiring only minimal persistence. CONCLUSION: This proof-of-concept simulation study suggests that Bayesian state estimation may provide a viable pathway to image guidance for surgical exposure in the abdomen, especially in the presence of dynamic intraoperative tissue displacement and deformation.

Quantifying Tumor and Vasculature Deformations during Laryngoscopy.

Retractors and scopes used in head and neck surgery to provide adequate surgical exposure also deform critical structures in the region. Surgeons typically use preoperative imaging to plan and guide their tumor resections, however the large tissue deformation resulting from placement of retractors and scopes reduces the utility of preoperative imaging as a reliable roadmap. We quantify the extent of tumor and vasculature deformation in patients with tumors of the larynx and pharynx undergoing diagnostic laryngoscopy. A mean tumor displacement of 1.02 cm was observed between the patients' pre- and intra-operative states. Mean vasculature displacement at key bifurcation points was 0.99 cm. Registration to the hyoid bone can reduce tumor displacement to 0.67 cm and improve carotid stem angle deviations but increase overall vasculature displacement. The large deformation results suggest limitations in reliance on preoperative imaging and that using specific landmarks intraoperatively or having more intraoperative information could help to compensate for these deviations and ultimately improve surgical success.

Novel Electrode Placement in Electrical Bioimpedance-Based Stroke Detection: Effects on Current Penetration and Injury Characterization in a Finite Element Model.

OBJECTIVE: Reducing time-to-treatment and providing acute management in stroke are essential for patient recovery. Electrical bioimpedance (EBI) is an inexpensive and non-invasive tissue measurement approach that has the potential to provide novel continuous intracranial monitoring-something not possible in current standard-of-care. While extensive previous work has evaluated the feasibility of EBI in diagnosing stroke, high-impedance anatomical features in the head have limited clinical translation. METHODS: The present study introduces novel electrode placements near highly-conductive cerebral spinal fluid (CSF) pathways to enhance electrical current penetration through the skull and increase detection accuracy of neurologic damage. Simulations were conducted on a realistic finite element model (FEM). Novel electrode placements at the tear ducts, soft palate and base of neck were evaluated. Classification accuracy was assessed in the presence of signal noise, patient variability, and electrode positioning. RESULTS: Algorithms were developed to successfully determine stroke etiology, location, and size relative to impedance measurements from a baseline scan. Novel electrode placements significantly increased stroke classification accuracy at various levels of signal noise (e.g., p < 0.001 at 40 dB). Novel electrodes also amplified current penetration, with up to 30% increase in current density and 57% increased sensitivity in central intracranial regions (p < 0.001). CONCLUSION: These findings support the use of novel electrode placements in EBI to overcome prior limitations, indicating a potential approach to increasing the technology's clinical utility in stroke identification. SIGNIFICANCE: A non-invasive EBI monitor for stroke could provide essential timely intervention and care of stroke patients.

CT for estimating adequacy of lymph node dissection in patients with squamous cell carcinoma of the head and neck.

BACKGROUND: Indices obtained from lymph node dissection specimens, specifically lymph node yield (LNY) and lymph node ratio (LNR), have prognostic significance in the setting of head and neck squamous cell carcinoma (HNSCCa). However, there are currently no validated tools to estimate adequacy of planned lymph node dissection using preoperative data. The present study sought to evaluate CT-derived estimates of lymphatic tissue volumes as a preoperative tool to guide cervical node dissection. METHODS: Fifteen cervical lymph node dissections were performed in 14 subjects with HNSCCa. Preoperative CT-derived estimates of lymphatic tissue volumes were compared with gross pathology tissue volume estimates and pathologically-determined LNY. RESULTS: Resected tissue volume (calculated using the triaxial ellipsoid method) correlates with CT-derived preoperative lymphatic volume estimates (r = 0.74, p = 0.003) while LNY does not(r = - 0.12, p = 0.67). When excluding pathologically enlarged lymph nodes ("refined" data), a negative correlation was observed between refined CT-derived volume estimates and refined LNY (r = - 0.65, p = 0.009). CONCLUSION: In the setting of cervical lymph node dissection, CT-derived lymphatic volume estimates correlate with resected tissue volume, but refined CT-derived volume estimates correlate negatively with refined LNY. TRIAL REGISTRATION: Retrospectively registered. LEVEL OF EVIDENCE: 4.

BandPass: A Bluetooth-Enabled Remote Monitoring Device for Sarcopenia.

As the United States population ages, managing pathologies that largely affect older adults, including sarcopenia (i.e., loss of muscle mass and strength) represents a significant and growing clinical challenge. In addition to increased rates of sarcopenia with age, its incidence and impact increase after acute illness, increasing the risk of functional decline, institutionalization, or death. Resistance-based exercises promote muscle regeneration and strength and are an advised therapy for such patients. Yet, such therapeutic exercises are normally conducted either under direct clinical oversight or unsupervised by patients at home, where compliance rates are low. The presented device, BandPass, aims to create an integrated force data detection and acquisition system for monitoring and transmitting at-home exercise force data to patients and clinicians. A potentiometer-based sensor was integrated to a resistance exercise band through the use of custom designed electronics, which incorporated Bluetooth Low Energy (BLE) for wireless transmission to a mobile 'app'. A protocol for calibrating the device was developed using a range of loads and validated in static benchtop and dynamic testing. Data from a pilot study with 7 older adults was also collected and analyzed to test the device. BandPass is 94% accurate with a coefficient of variation (CoV) of 4.9% and sensitivity of 150g. The pilot study recorded 147 exercises, allowing for analysis on patients' exercise performances. BandPass was successfully able to measure force continuously over time during exercises, measure longitudinal compliance with exercises, and quantify force continuously over time. A mobile health (mHealth) force-sensing system allows for the remote monitoring of prescribed in-home resistance exercise band programs for at-risk older adults, bridging the gap between clinicians and patients.

Usability Assessment of a Bluetooth-Enabled Resistance Exercise Band Among Young Adults.

BACKGROUND: Resistance-based exercises effectively enhance muscle strength, which is especially important in older populations as it reduces the risk of disability. Our group developed a Bluetooth-enabled handle for resistance exercise bands that wirelessly transmits relative force data through low-energy Bluetooth to a local smartphone or similar device. We present a usability assessment that evaluates an exercise system featuring a novel Bluetooth-enabled resistance exercise band, ultimately intended to expand the accessibility of resistance training through technology-enhanced home-based exercise programs for older adults. Although our target population is older adults, we assess the user experience among younger adults as a convenient and meaningful starting point in the testing and development of our device. METHODS: There were 32 young adults participating in three exercise sessions with the exercise band, after which each completed an adapted version of the Usefulness, Satisfaction, and Ease (USE) questionnaire to characterize the exercise system's strengths and weaknesses in usability. RESULTS: Questionnaire data reflected a positive and consistent user experience, with all 20 items receiving mean scores greater than 5.0 on a seven-point Likert scale. There were no specific areas of significant weakness in the device's user experience. CONCLUSIONS: The positive reception among young adults is a promising indication that the device can be successfully incorporated into exercise interventions and that the system can be further developed and tested for the target population of older adults.

Proposed mechanism for reduced jugular vein flow in microgravity.

Internal jugular flow is reduced in space compared with supine values, which can be associated with internal jugular vein (IJV) thrombosis. The mechanism is unknown but important to understand to prevent potentially serious vein thromboses on long duration flights. We used a novel, microgravity-focused numerical model of the cranial vascular circulation to develop hypotheses for the reduced flow. This model includes the effects of removing hydrostatic gradients and tissue compressive forces - unique effects of weightlessness. The IJV in the model incorporates sensitivity to transmural pressure across the vein, which can dramatically affect resistance and flow in the vein. The model predicts reduced IJV flow in space. Although tissue weight in the neck is reduced in weightlessness, increasing transmural pressure, this is more than offset by the reduction in venous pressure produced by the loss of hydrostatic gradients and tissue pressures throughout the body. This results in a negative transmural pressure and increased IJV resistance. Unlike the IJV, the walls of the vertebral plexus are rigid; transmural pressure does not affect its resistance and so its flow increases in microgravity. This overall result is supported by spaceflight measurements, showing reduced IJV area inflight compared with supine values preflight. Significantly, this hypothesis suggests that interventions that further decrease internal IJV pressure (such as lower body negative pressure), which are not assisted by other drainage mechanisms (e.g. gravity), might lead to stagnant flow or IJV collapse with reduced flow, which could increase rather than decrease the risk of venous thrombosis.

Cardiac eigen imaging: a novel method to isolate cardiac activity in thoracic electrical impedance tomography.

OBJECTIVE: As the global burden of cardiovascular disease increases, proactive cardiovascular healthcare by means of accurate, precise, continuous, and non-invasive monitoring is becoming crucial. However, no current device is able to provide cardiac hemodynamic monitoring with the aforementioned criterion. Electrical impedance tomography (EIT) is an inexpensive, non-invasive imaging modality that can provide real-time images of internal conductivity distributions that describe physiological activity. This work explores and compares a standard approach of regular cardiac gated averaging (RCGA) and a newly developed method, cardiac eigen-imaging (CEI), based on the singular value decomposition (SVD) to isolate cardiac activity in thoracic EIT. APPROACH: EIT and heart-rate (HR) data were collected from 20 heart-failure patients preceding echocardiography. Features from RCGA and CEI images were correlated with stroke volume (SV) from echocardiography and image reconstruction parameters were optimized using leave-one-out (LOO) cross-validation. MAIN RESULTS: CEI per-pixel-based features achieved a Pearson correlation coefficient of 0.80 with SV relative to 0.72 with RCGA. CEI had 33 high-correlating pixels while RCGA had 8. High-correlating pixels tend to concentrate in the right-ventricle (RV) when referenced to a general chest model. SIGNIFICANCE: While both RCGA and CEI images had high-correlating pixels, CEI had higher correlations, a larger number of high-correlating pixels, and unlike RCGA is not dependent on the quality of the HR data collected. The observed performance of the CEI approach represents a promising step forward for EIT-based cardiac monitoring in either clinical or ambulatory settings.

Bioimpedance Sensing Surgical Drill - Computational Modelling and Experimental Validation.

Surgical drilling to fixate dental implants is associated with high risk of injury to the inferior alveolar nerve (IAN) and the maxillary sinus. Current common practice is to use pre-operative radiographs to plan and drill with no real-time feedback of drill tip position with respect to these critical structures. Real-time proximity sensing of the IAN and maxillary sinus by measuring the electrical impedance properties of tissues, directly from the drill tip, while drilling may reduce and eventually eliminate this risk. Sensing impedance to detect tissue boundaries needs sensor geometry optimization for maximum detection distance. We have created a finite element method (FEM) based simulation platform that yields accurately impedances for different conductivities, frequencies and sensor geometries.

A 1 MHz Miniaturized Electrical Impedance Tomography System for Prostate Imaging.

An ASIC for a high frequency electrical impedance tomography (EIT) imaging system for prostate cancer screening is presented. The ASIC enables a small form-factor architecture, which ensures high signal-to-noise ratio (SNR) at MHz frequencies. The 4-channel ASIC was designed and fabricated in a standard CMOS 0.18- µm technology and integrates a novel current driver for current stimulus, instrumentation amplifier to interface with the tissue, VGA to provide variable gain and ADC with SPI interface for digitization. A prototype miniaturized EIT system was built and it was evaluated using a model transrectal imaging probe immersed into a tank filled with saline and a metal inclusion that demonstrated the open-domain problem of imaging prostate cancer lesion. The system maintained an SNR between 66 and 76 dB over the frequency range of 500 Hz to 1 MHz. Also, it produced reconstructed EIT images that depicted the presence of the small metal inclusion that modeled a prostate cancer imaging application.

Phantom Studies of Fused-Data TREIT Using Only Biopsy-Probe Electrodes.

Transrectal electrical impedance tomography (TREIT) is a novel imaging modality being developed for prostate biopsy guidance and cancer characterization. We describe a novel fused-data TREIT (fd-TREIT) system and approach developed to improve imaging robustness and evaluate it on challenging clinically-representative phantoms. The new approach incorporates 8 electrodes (in 2 rows) on a biopsy probe (BP) and 12 electrodes on the face of a transrectal ultrasound (TRUS) probe and includes a biopsy gun, instrument tracking, 3D-printed needle guide, and EIT hardware and software. The approach was evaluated via simulation, a series of prostate-shaped gel phantoms, and an ex vivo bovine tissue sample using only absolute reconstructions. The simulations surprisingly found that using only biopsy-probe electrode measurements, i.e. omitting TRUS-probe electrode measurements, significantly improves robustness to noise thus leading to simpler modeling and significant decreases in computational times (~13x speed-up/reconstructions in ~27 minutes). The gel phantom experiments resulted in reconstructions with area under the curve (AUC) values extracted from receiver operator characteristic curves of >0.85 for 4 out of the 5 tests, and when incorporating inclusion boundaries resulted in absolute reconstructions yielding 1.9% and 12.2% average percent errors for 3 consistent tests and all 5 tests, respectively. Ex vivo bovine tests revealed qualitatively that the fd-TREIT approach can largely discriminate a complex adipose and muscle interface in a realistic setting using data from 9 biopsy probe states (biopsy core locations). The algorithms developed here on challenging phantoms suggest strong promise for this technology to aid in imaging during routine 12-core biopsies.