Method-comparison study between a watch-like sensor and a cuff-based device for 24-h ambulatory blood pressure monitoring.

The use of 24-h ambulatory blood pressure monitoring (ABPM) has been continuously increasing over the last decades. However, cuff-based devices may cause discomfort, particularly at night, leading to potentially non-representative blood pressure (BP) values. We investigated the feasibility of a cuff-less BP monitoring solution in 67 subjects undergoing conventional 24-h ABPM. A watch-like optical sensor was attached at the upper arm or wrist at the contralateral side of the cuff. Systolic (SBP) and diastolic BP (DBP) values were estimated from the measured optical signals by pulse wave analysis. Average 24-h, daytime and nighttime BP values were compared between the conventional monitor and the cuff-less sensor. The differences between both methods-expressed as mean ± standard deviation (95% limits of agreement)-were of - 1.8 ± 6.2 mmHg (- 13.9, 10.3) on SBP and - 2.3 ± 5.4 mmHg (- 13.0, 8.3) on DBP for 24-h averages, of - 1.5 ± 6.6 mmHg (- 14.4, 11.4) on SBP and - 1.8 ± 5.9 mmHg (- 13.4, 9.9) on DBP for daytime averages, and of 0.4 ± 7.5 mmHg (- 14.4, 15.1) on SBP and - 1.3 ± 6.8 mmHg (- 14.7, 12.0) on DBP for nighttime averages. These results encouragingly suggest that cuff-less 24-h ABPM may soon become a clinical possibility.

Split electrodes for electrical-conductivity-based tissue discrimination.

This work presents a method to minimize the inadvertent cutting of tissues in surgeries involving bone drilling. We present electrical impedance measurements as an assistive technology to image-guided surgery to achieve online guidance. Proposed concept is to identify and localize the landmarks via impedance measurements and then use this information to superimpose the estimated drilling trajectory on the offline maps obtained by pre-operative imaging. To this end., we propose an asymmetric electrode geometry., split electrodes., capable of distinguishing impedance variations as a function of rotation angle. The feasibility of the proposed approach is verified with numerical analysis. A probe with stainless steel electrodes has been fabricated and tested with a technical phantom. Although the results are impacted by a non-ideality in the phantom., we could show that the variation of impedance as a function of rotation angle can be used to localize the regions with different impedivities. Clinical Relevance- Presented approach may be used to minimize the inadvertent cutting of tissues in surgeries involving bone drilling.

Influence of Measurement Location on Reflectance Pulse Oximetry in Sleep Apnea Patients: Wrist vs. Upper Arm.

Peripheral oxygen saturation (SpO2) plays a key role in diagnosing sleep apnea. It is mainly measured via transmission pulse oximetry at the fingertip, an approach less suited for long-term monitoring over several nights.In this study we tested a more patient-friendly solution via a reflectance pulse oximetry device. Having previously observed issues with pulse oximetry at the wrist, we investigated in this study the influence of the location of our device (upper arm vs. wrist) to measure SpO2. Accuracy was compared against state-of-the-art fingertip SpO2 measurements during a full overnight polysomnography in nine patients with suspected sleep apnea.The upper arm location clearly showed a lower root mean square error ARMS = 1.8% than the wrist ARMS = 2.5% and a lower rate of automatic data rejection (19% vs 25%). Irrespective of the measurement location the accuracies obtained comply with the ISO standard and the FDA guidance for pulse oximeters. In contrast to the wrist, the upper arm location seemed to be more resilient to deteriorating influences such as venous blood.Reflectance pulse oximetry at the wrist remains challenging but the upper arm could provide remedy for more robust SpO2 estimates to reliably screen for sleep apnea and other diseases.Clinical Relevance- The performance of reflectance pulse oximetry measured at the upper arm during sleep is superior to measurements at the wrist which are perturbed by undesired large fluctuations suspected to be caused by venous blood. If confirmed, this could also apply to the optical measurement of other vital signs such as blood pressure.

Pulse Oximetry at the Wrist During Sleep: Performance, Challenges and Perspectives.

The state-of-the-art non-invasive measurement of peripheral oxygen saturation (SpO2) during sleep is mainly based on pulse oximetry at the fingertip. Although this approach is noninvasive, it can still be obtrusive and cumbersome to apply, in particular for ambulatory monitoring over several nights.We developed a wrist-worn reflectance pulse oximetry device which can be embedded in a watch, making it less obtrusive and easy to apply. This device was tested in an ongoing clinical study on 57 subjects (33 patients and 24 healthy volunteers) undergoing a full overnight polysomnography recording. The accuracy was evaluated against state-of-the-art fingertip SpO2 measurements.In the 54 subjects available for analysis we obtained an SpO2 accuracy (ARMS) of 3.4 % when automatically rejecting 17.7 % of signals due to low quality. When further excluding measurements suffering from insufficient contact of the watch with the skin an ARMS of 2.7 % was obtained while rejecting a total of 23.2 % measurements. These accuracies comply with the ISO standard and the FDA guidance for pulse oximeters.The present results are promising and pave the way for unobtrusive and continuous monitoring of SpO2 to screen for sleep disordered breathing. Nonetheless, contact pressure and venous blood have shown to adversely affect the SpO2 estimation and remain a challenge for wrist-based reflectance pulse oximetry.

ECG-Quality Assessment of Dry-Electrode Cooperative Sensors.

Classical approaches for measuring high-quality ECG require the use of gel electrodes and individually shielded cables, which limit patient comfort, especially in long-term use. We recently introduced a novel sensing architecture-so-called cooperative sensors-that allow the use of active dry electrodes connected by two unshielded wires. The aim of this work is to qualitatively evaluate an ECG recorded with a dry-electrode cooperative-sensor system. To that end, preliminary observations were made on three healthy subjects. The ECGs were concurrently recorded with cooperative sensors and a gold-standard 12-lead ECG device during a stress test on a stationary bicycle. First experimental measurements demonstrated the reliability of the approach for a wearable 12-lead ECG monitoring system tested in real settings.

Electrical Impedance to Assess Facial Nerve Proximity During Robotic Cochlear Implantation.

Reported studies pertaining to needle guidance suggest that tissue impedance available from neuromonitoring systems can be used to discriminate nerve tissue proximity. In this pilot study, the existence of a relationship between intraoperative electrical impedance and tissue density, estimated from computer tomography (CT) images, is evaluated in the mastoid bone of in vivo sheep. In five subjects, nine trajectories were drilled using an image-guided surgical robot. Per trajectory, five measurement points near the facial nerve were accessed and electrical impedance was measured (≤1 KHz) using a multipolar electrode probe. Micro-CT was used postoperatively to measure the distances from the drilled trajectories to the facial nerve. Tissue density was determined from coregistered preoperative CT images and, following sensitivity field modeling of the measuring tip, tissue resistivity was calculated. The relationship between impedance and density was determined for 29 trajectories passing or intersecting the facial nerve. A monotonic decrease in impedance magnitude was observed in all trajectories with a drill axis intersecting the facial nerve. Mean tissue densities intersecting with the facial nerve (971-1161 HU) were different (p <0.01) from those along safe trajectories passing the nerve (1194-1449 HU). However, mean resistivity values of trajectories intersecting the facial nerve (14-24 Ωm) were similar to those of safe passing trajectories (17-23 Ωm). The determined relationship between tissue density and electrical impedance during neuromonitoring of the facial nerve suggests that impedance spectroscopy may be used to increase the accuracy of tissue discrimination, and ultimately improve nerve safety distance assessment in the future.

PPG-Based Blood Pressure Monitoring by Pulse Wave Analysis: Calibration Parameters are Stable for Three Months.

The current non-invasive gold standard for the measurement of blood pressure (BP) is the oscillometric cuff at the upper arm, despite its known limitations. In particular, its poor adequacy with continuous monitoring and its measurement incommodity call for the development of simpler and more convenient solutions. Among these, solutions based on pulse wave analysis (PWA) and photoplethysmography (PPG) are of particular interest, due to their low-cost, strong patient compliance, and applicability in and out of clinical settings. In that context, we have recently disclosed a PPG-based PWA algorithm (oBPM™) dedicated to the continuous monitoring of BP in patients undergoing induction of general anesthesia. As is standard with PPG-based BP monitoring techniques, an initial calibration procedure with a reference device is required to allow the estimation of absolute values of BP (in mmHg). However, due to their sensitivity to peripheral effects such as vasomotion, the applicability of PPG-based techniques is often limited by the constant need of re-calibration procedures, sometimes in matters of minutes. In the present study, we evaluated the long-term stability of the calibration for our algorithm by performing PPG measurements at irregular time intervals over a period of 3 months in 13 healthy volunteers. For each measurement, diastolic BP (DBP) was assessed by an oscillometric device and estimated by the oBPM™ algorithm. We found the calibration to remain stable over the entire 3-month period, with estimation errors remaining stable over time and complying with the ISO 81060-2:2018 standard. In addition, we verified - in 11 of our 13 subjects - the sensitivity of the oBPM™ algorithm to changes in DBP. This was done in a protocol involving static leg extension exercises. Excellent trending ability (average per-subject concordance rate of 97.7 ± 5.2 %, and correlation coefficient of 0.98 ± 0.02, p <; 0.001) was found between cuff-derived DBP changes and our estimates. These findings provide a strong added value to the practical usability of the proposed PPG-based PWA approach to BP monitoring, particularly for the clinical management of hypertensive patients in and out of clinics, for whom a simple and comfortable continuous alternative to the oscillometric cuff would be strongly preferred.

Performance Assessment of a Dedicated Reflectance Pulse Oximeter in a Neonatal Intensive Care Unit.

The measurement of peripheral oxygen saturation (SpO2) in neonatal intensive care units (NICUs) poses a significant challenge. Motion artifacts due to the patient's limb motion induce many false alarms, which in turn cause an additional workload for the medical staff and anxiety for the parents. We developed a reflectance pulse oximeter dedicated to be placed at the patient's forehead, which is less prone to such artifacts. We trained our algorithms for SpO2 estimation on 8 adult healthy volunteers participating in a controlled desaturation study. We then validated our SpO2 monitoring system on 25 newborn patients monitored in an NICU. We further evaluated the versatility and resilience to low signal-tonoise ratios (SNR) of our solution by testing it on signals acquired in a low-perfusion region (upper right part of the chest) of our adult volunteers. We obtained an SpO2 estimation accuracy ($A _{\mathbf {rms}}$) of 1.9 % and 3.1 % at the forehead and the chest in our adult volunteers, respectively. These performances were obtained after automatic rejection of 0.1 % and 30.0 %, respectively, of low-SNR signals by our dedicated quality index. In the dataset recorded on newborn patients in the NICU, we obtained an accuracy of 3.9 % after automatic rejection of 11.7 % of low-SNR signals by our quality index. These analyses were carried out following the procedures suggested by the ISO 80601-2-61:2011 standard, which specifies a target $A _{\mathbf {rms}} \le $ 4 % for SpO2 monitoring applications. These promising results suggest that reflectance pulse oximeters can achieve clinically acceptable accuracy, while being placed at locations less sensitive to limb motion artifacts - such as the forehead - thereby reducing the amount of SpO2-related false alarms in NICUs.

Body-monitoring with photonic textiles: a reflective heartbeat sensor based on polymer optical fibres.

Knowledge of an individual's skin condition is important for pressure ulcer prevention. Detecting early changes in skin through perfusion, oxygen saturation values, and pressure on tissue and subsequent therapeutic intervention could increase patients' quality of life drastically. However, most existing sensing options create additional risk of ulcer development due to further pressure on and chafing of the skin. Here, as a first component, we present a flexible, photonic textile-based sensor for the continuous monitoring of the heartbeat and blood flow. Polymer optical fibres (POFs) are melt-spun continuously and characterized optically and mechanically before being embroidered. The resulting sensor shows flexibility when embroidered into a moisture-wicking fabric, and withstands disinfection with hospital-type laundry cycles. Additionally, the new sensor textile shows a lower static coefficient of friction (COF) than conventionally used bedsheets in both dry and sweaty conditions versus a skin model. Finally, we demonstrate the functionality of our sensor by measuring the heartbeat at the forehead in reflection mode and comparing it with commercial finger photoplethysmography for several subjects. Our results will allow the development of flexible, individualized, and fully textile-integrated wearable sensors for sensitive skin conditions and general long-term monitoring of patients with risk for pressure ulcer.

A Neuromonitoring Approach to Facial Nerve Preservation During Image-guided Robotic Cochlear Implantation.

HYPOTHESIS: A multielectrode probe in combination with an optimized stimulation protocol could provide sufficient sensitivity and specificity to act as an effective safety mechanism for preservation of the facial nerve in case of an unsafe drill distance during image-guided cochlear implantation. BACKGROUND: A minimally invasive cochlear implantation is enabled by image-guided and robotic-assisted drilling of an access tunnel to the middle ear cavity. The approach requires the drill to pass at distances below 1  mm from the facial nerve and thus safety mechanisms for protecting this critical structure are required. Neuromonitoring is currently used to determine facial nerve proximity in mastoidectomy but lacks sensitivity and specificity necessaries to effectively distinguish the close distance ranges experienced in the minimally invasive approach, possibly because of current shunting of uninsulated stimulating drilling tools in the drill tunnel and because of nonoptimized stimulation parameters. To this end, we propose an advanced neuromonitoring approach using varying levels of stimulation parameters together with an integrated bipolar and monopolar stimulating probe. MATERIALS AND METHODS: An in vivo study (sheep model) was conducted in which measurements at specifically planned and navigated lateral distances from the facial nerve were performed to determine if specific sets of stimulation parameters in combination with the proposed neuromonitoring system could reliably detect an imminent collision with the facial nerve. For the accurate positioning of the neuromonitoring probe, a dedicated robotic system for image-guided cochlear implantation was used and drilling accuracy was corrected on postoperative microcomputed tomographic images. RESULTS: From 29 trajectories analyzed in five different subjects, a correlation between stimulus threshold and drill-to-facial nerve distance was found in trajectories colliding with the facial nerve (distance <0.1  mm). The shortest pulse duration that provided the highest linear correlation between stimulation intensity and drill-to-facial nerve distance was 250  µs. Only at low stimulus intensity values (≤0.3  mA) and with the bipolar configurations of the probe did the neuromonitoring system enable sufficient lateral specificity (>95%) at distances to the facial nerve below 0.5  mm. However, reduction in stimulus threshold to 0.3  mA or lower resulted in a decrease of facial nerve distance detection range below 0.1  mm (>95% sensitivity). Subsequent histopathology follow-up of three representative cases where the neuromonitoring system could reliably detect a collision with the facial nerve (distance <0.1  mm) revealed either mild or inexistent damage to the nerve fascicles. CONCLUSION: Our findings suggest that although no general correlation between facial nerve distance and stimulation threshold existed, possibly because of variances in patient-specific anatomy, correlations at very close distances to the facial nerve and high levels of specificity would enable a binary response warning system to be developed using the proposed probe at low stimulation currents.

Clinical validation of LTMS-S: A wearable system for vital signs monitoring.

LTMS-S is a new wearable system for the monitoring of several physiological signals--including a two-lead electrocardiogram (ECG)--and parameters, such as the heart rate, the breathing rate, the peripheral oxygen saturation (SpO2), the core body temperature (CBT), and the physical activity. All signals are measured using only three sensors embedded within a vest. The sensors are standalone with their own rechargeable battery, memory, wireless communication and with an autonomy exceeding 24 hours. This paper presents the results of the clinical validation of the LTMS-S system.

Noninvasive and Nonocclusive Blood Pressure Estimation Via a Chest Sensor.

The clinical demand for a device to monitor blood pressure (BP) in ambulatory scenarios with minimal use of inflation cuffs is increasing. Based on the so-called pulse wave velocity (PWV) principle, this paper introduces and evaluates a novel concept of BP monitor that can be fully integrated within a chest sensor. After a preliminary calibration, the sensor provides nonocclusive beat-by-beat estimations of mean arterial pressure (MAP) by measuring the pulse transit time (PTT) of arterial pressure pulses travelling from the ascending aorta toward the subcutaneous vasculature of the chest. In a cohort of 15 healthy male subjects, a total of 462 simultaneous readings consisting of reference MAP and chest PTT were acquired. Each subject was recorded at three different days: D, D+3, and D+14. Overall, the implemented protocol induced MAP values to range from 80 ± 6 mmHg in baseline, to 107 ± 9 mmHg during isometric handgrip maneuvers. Agreement between reference and chest-sensor MAP values was tested by using intraclass correlation coefficient (ICC = 0.78) and Bland-Altman analysis (mean error = 0.7 mmHg, standard deviation = 5.1 mmHg). The cumulative percentage of MAP values provided by the chest sensor falling within a range of ±5 mmHg compared to reference MAP readings was of 70%, within ±10 mmHg was of 91%, and within ±15 mmHg was of 98%. These results point at the fact that the chest sensor complies with the British Hypertension Society requirements of Grade A BP monitors, when applied to MAP readings. Grade A performance was maintained even two weeks after having performed the initial subject-dependent calibration. In conclusion, this paper introduces a sensor and a calibration strategy to perform MAP measurements at the chest. The encouraging performance of the presented technique paves the way toward an ambulatory compliant, continuous, and nonocclusive BP monitoring system.

Toward morphological thoracic EIT: major signal sources correspond to respective organ locations in CT.

Lung and cardiovascular monitoring applications of electrical impedance tomography (EIT) require localization of relevant functional structures or organs of interest within the reconstructed images. We describe an algorithm for automatic detection of heart and lung regions in a time series of EIT images. Using EIT reconstruction based on anatomical models, candidate regions are identified in the frequency domain and image-based classification techniques applied. The algorithm was validated on a set of simultaneously recorded EIT and CT data in pigs. In all cases, identified regions in EIT images corresponded to those manually segmented in the matched CT image. Results demonstrate the ability of EIT technology to reconstruct relevant impedance changes at their anatomical locations, provided that information about the thoracic boundary shape (and electrode positions) are used for reconstruction.