Effect of Respiration on the Characteristic Ratios of Oscillometric Pulse Amplitude Envelope in Blood Pressure Measurement

Systolic and diastolic blood pressures (BPs) are important physiological parameters for disease diagnosis. Systolic and diastolic characteristic ratios derived from oscillometric pulse waveform have been widely used to estimate automated non-invasive BPs in oscillometric BP measurement devices. The oscillometric pulse waveform is easily influenced by respiration, which may cause variability to the characteristic ratios and subsequently BP measurement. This study quantitatively investigated how respiration patterns (i.e., normal breathing and deep breathing) affect the systolic and diastolic characteristic ratios. The study was performed with clinical data collected from 39 healthy subjects, and each subject conducted BP measurements during normal and deep breathings. Analytical results showed that the systolic characteristic ratio increased significantly from 0.52 ± 0.13 under normal breathing to 0.58 ± 0.14under deep breathing (p < 0.05), and the diastolic characteristic ratio was not significantly affected from 0.75 ± 0.12 under normal breathing to 0.76 ± 0.13 under deep breathing (p = 0.48). In conclusion, deep breathing significantly affected the systolic characteristic ratio, suggesting that automated oscillometric BP device which is validated under resting condition should be strictly used for measurements under resting condition

Significantly Reduced Blood Pressure Measurement Variability for Both Normotensive and Hypertensive Subjects: Effect of Polynomial Curve Fitting of Oscillometric Pulses

This study aimed to compare within-subject blood pressure (BP) variabilities from different measurement techniques. Cuff pressures from three repeated BP measurements were obtained from 30 normotensive and 30 hypertensive subjects. Automatic BPs were determined from the pulses with normalised peak amplitude larger than a threshold (0.5 for SBP, 0.7 for DBP, and 1.0 for MAP). They were also determined from cuff pressures associated with the above thresholds on a fitted curve polynomial curve of the oscillometric pulse peaks. Finally, the standard deviation (SD) of three repeats and its coefficient of variability (CV) were compared between the two automatic techniques. For the normotensive group, polynomial curve fitting significantly reduced SD of repeats from 3.6 to 2.5 mmHg for SBP and from 3.7 to 2.1 mmHg for MAP and reduced CV from 3.0% to 2.2% for SBP and from 4.3% to 2.4% for MAP (all P<0.01). For the hypertensive group, SD of repeats decreased from 6.5 to 5.5 mmHg for SBP and from 6.7 to 4.2 mmHg for MAP, and CV decreased from 4.2% to 3.6% for SBP and from 5.8% to 3.8% for MAP (all P<0.05). In conclusion, polynomial curve fitting of oscillometric pulses had the ability to reduce automatic BP measurement variability

Acoustic sensing as a novel approach for cardiovascular monitoring at the wrist

Cardiovascular diseases are the number one cause of deaths globally. An increased cardiovascular risk can be detected by a regular monitoring of the vital signs including the heart rate, the heart rate variability (HRV) and the blood pressure. For a user to undergo continuous vital sign monitoring, wearable systems prove to be very useful as the device can be integrated into the user's lifestyle without affecting the daily activities. However, the main challenge associated with the monitoring of these cardiovascular parameters is the requirement of different sensing mechanisms at different measurement sites. There is not a single wearable device that can provide sufficient physiological information to track the vital signs from a single site on the body. This thesis proposes a novel concept of using acoustic sensing over the radial artery to extract cardiac parameters for vital sign monitoring. A wearable system consisting of a microphone is designed to allow the detection of the heart sounds together with the pulse wave, an attribute not possible with existing wrist-based sensing methods. Methods: The acoustic signals recorded from the radial artery are a continuous reflection of the instantaneous cardiac activity. These signals are studied and characterised using different algorithms to extract cardiovascular parameters. The validity of the proposed principle is firstly demonstrated using a novel algorithm to extract the heart rate from these signals. The algorithm utilises the power spectral analysis of the acoustic pulse signal to detect the S1 sounds and additionally, the K-means method to remove motion artifacts for an accurate heartbeat detection. The HRV in the short-term acoustic recordings is found by extracting the S1 events using the relative information between the short- and long-term energies of the signal. The S1 events are localised using three different characteristic points and the best representation is found by comparing the instantaneous heart rate profiles. The possibility of measuring the blood pressure using the wearable device is shown by recording the acoustic signal under the influence of external pressure applied on the arterial branch. The temporal and spectral characteristics of the acoustic signal are utilised to extract the feature signals and obtain a relationship with the systolic blood pressure (SBP) and diastolic blood pressure (DBP) respectively. Results: This thesis proposes three different algorithms to find the heart rate, the HRV and the SBP/ DBP readings from the acoustic signals recorded at the wrist. The results obtained by each algorithm are as follows: 1. The heart rate algorithm is validated on a dataset consisting of 12 subjects with a data length of 6 hours. The results demonstrate an accuracy of 98.78%, mean absolute error of 0.28 bpm, limits of agreement between -1.68 and 1.69 bpm, and a correlation coefficient of 0.998 with reference to a state-of-the-art PPG-based commercial device. A high statistical agreement between the heart rate obtained from the acoustic signal and the photoplethysmography (PPG) signal is observed. 2. The HRV algorithm is validated on the short-term acoustic signals of 5-minutes duration recorded from each of the 12 subjects. A comparison is established with the simultaneously recorded electrocardiography (ECG) and PPG signals respectively. The instantaneous heart rate for all the subjects combined together achieves an accuracy of 98.50% and 98.96% with respect to the ECG and PPG signals respectively. The results for the time-domain and frequency-domain HRV parameters also demonstrate high statistical agreement with the ECG and PPG signals respectively. 3. The algorithm proposed for the SBP/ DBP determination is validated on 104 acoustic signals recorded from 40 adult subjects. The experimental outputs when compared with the reference arm- and wrist-based monitors produce a mean error of less than 2 mmHg and a standard deviation of error around 6 mmHg. Based on these results, this thesis shows the potential of this new sensing modality to be used as an alternative, or to complement existing methods, for the continuous monitoring of heart rate and HRV, and spot measurement of the blood pressure at the wrist.Open Acces

Non-invasive venous oximetry through venous blood volume modulation

For decades, the monitoring of mixed venous oxygen saturation has been done invasively using fibre-optic catheters. This procedure is not without risk as complications may arise from catheterization. This thesis describes an alternative and novel means of monitoring venous oxygen saturation. The technique outlined involves inducing regular modulations of the venous blood volume and the associated measurement of those modulations using an optical sensor. Just as pulse oximetry utilizes the natural arterial pulse to perform spectral analysis of the peripheral blood in order to estimate the arterial blood oxygen saturation, the new venous oximetry technique uses the artificially generated pulse to perform the task of measuring peripheral venous oxygen saturation. This thesis explores and investigates the feasibility of this new venous oximetry technique. A heuristic model was first developed to predict the effects of introducing an artificially generated pulsatile signal in the venous system. The effect on the underlying natural arterial pulsation was also examined. Experiments were then conducted to justify and interpret the model developed. Other experiments were also conducted to optimize the design of the artificial pulse-based venous oximeter, to explore the effects of prolonged modulation of the venous system and to establish evidence that the measurements made were indeed related to venous oxygen saturation. It is concluded that the new venous oximetry technique is indeed feasible and with further research and development would one day replace the current invasive method

Methods and Instrumentation for Non-Invasive Assessment of the Cardiovascular Condition

Tese de doutoramento em Física (Pré-Bolonha), Especialidade de Física Tecnológica, apresentada à Faculdade de Ciências e Tecnologia da Universidade de CoimbraAs doenças cardiovasculares (DCVs) são a principal causa de morte a nível mundial e largamente responsáveis pelos custos crescentes nos sistemas de saúde. Nos últimos anos, a comunidade médica tem vindo a demonstrar um grande interesse na avaliação da rigidez arterial local, pressão arterial central e na análise da onda de pressão, devido aos seus valores preditivos no desenvolvimento deste tipo de patologias. Apesar da sua relevância, estes parâmetros hemodinâmicos permanecem particularmente difíceis de medir na prática clínica, já que a maioria dos dispositivos disponíveis exigem elevados conhecimentos técnicos (introduzindo a dependência de um operador), tecnologias dispendiosas ou apresentam abordagens de análise ineficientes. Este trabalho de investigação encontra assim a sua motivação no potencial impacto que instrumentação não-invasiva, exata e de fácil utilização pode ter na monitorização da condição hemodinâmica e no diagnóstico precoce e acompanhamento de DCVs. Neste contexto, uma nova geração de protótipos baseados na combinação de diferentes tipos de sensores eletromecânicos, bem como um conjunto de algoritmos de processamento de sinal adequados à extração de múltiplos parâmetros hemodinâmicos foram desenvolvidos. Dependendo do marcador de risco cardiovascular a ser avaliado, dois grandes grupos de dispositivos foram projetados. O primeiro grupo, focado na avaliação da rigidez arterial local, explorou uma configuração dupla inovadora com dois sensores acústicos ou piezoelétricos (PZs) para a medição da velocidade da onda de pulso (VOP) e outros índices temporais relevantes, num curto segmento da artéria carótida. O outro grupo, centrado na avaliação contínua da pressão arterial sanguínea (PAS) e onda de pressão arterial (OPA), também na artéria carótida, usou uma unidade vibrador-acelerómetro montada num mesmo suporte que permitiu ao acelerómetro detetar as vibrações produzidas, atenuadas e moduladas em amplitude quando em contacto mecânico com a parede do vaso. Os protótipos desenvolvidos foram extensivamente caracterizados em sistemas de bancada de teste, desenvolvidos para este efeito e capazes de reproduzir a variabilidade de uma ampla gama de situações clinicamente relevantes, bem como em condições in vivo. Relativamente à avaliação da rigidez arterial local, a primeira e segunda gerações de protótipos desenvolvidos apresentaram boa exatidão nos ensaios de resolução temporal realizados em tubos elásticos de bancadas de teste. O algoritmo de correlação cruzada exibiu a capacidade de medir VOPs altas (≈ 19 ms-1 e 14 ms-1) com erros relativos e coeficientes de variação inferiores a 10 % para os diferentes protótipos. Os sinais adquiridos provaram ser robustos e repetíveis, não sofrendo efeitos de crosstalk. Os resultados obtidos no estudo de validação pré-clínica em vinte indivíduos saudáveis com a segunda geração de protótipos foram ainda bastante satisfatórios. As VOPs carotídeas médias obtidas apresentaram uma correlação linear e forte entre si, estando os resultados próximos dos valores obtidos noutros estudos de referência. Além disso, a capacidade de reproduzir perfis de onda pressão distintos usando as sondas PZs foi também mostrada, quer utilizando o processo de desconvolução quer um circuito eletrónico integrador dedicado. No que diz respeito à avaliação da PAS e OPA, o processo de desmodulação produziu excelentes resultados na recuperação da morfologia da onda de pressão em condições de bancada de teste e in vivo. Para os dois protótipos desenvolvidos, várias formas de onda foram extraídas, com exatidão, das portadoras moduladas de aceleração, corrente ou potência elétricas, usando os algoritmos de deteção do envelope e do produto. Na bancada de teste foi possível reproduzir a forma de onda de pressão para posições de aplanação do tubo elástico sucessivamente mais elevadas com um erro quadrático médio de 2.4 ± 0.51 %, quando considerado o melhor método de extração. A eficácia de um novo método de calibração focado na utilização de curvas empíricas que convertem aceleração em pressão foi também demonstrado. Através da conservação da amplitude da portadora de aceleração, foi possível determinar os valores de pressão máximo, mínimo, médio e de pulso com erros relativos inferiores a 10 % em condições de bancada. Além disso, as diferenças de pressão entre o último protótipo desenvolvido e o sistema de referência foram, em média, ≤ 5 ± 8 mmHg, satisfazendo os critérios de exatidão de sistemas de medição de PAS clinicamente validados. Embora estudos de validação clínica sejam ainda necessários, os resultados globais obtidos neste trabalho para os dois principais tipos de protótipos dão bons indicadores quanto à sua utilização como alternativas válidas aos sistemas atualmente disponíveis, tanto em ambientes clínico quanto de investigação.Cardiovascular diseases (CVDs) are the leading cause of death worldwide and largely responsible for the ever increasing costs in healthcare systems. In the last few years, the medical community has demonstrated a great interest in local arterial stiffness, central blood pressure assessment and pressure waveform analysis, due to their predictive values in the development of this type of pathologies. Despite their significance, these hemodynamic parameters remain particularly challenging to measure in standard clinical practice since most available devices require high technical expertise (introducing operator dependence), burdensome technologies and/or present ineffective analysis approaches. This research work finds its motivation in the potential impact that non-invasive, accurate and easy-to-use instrumentation could have on the monitoring of hemodynamic condition and on the diagnosis and control of early stages of CVDs. In this context, a new generation of prototypes based on the combination of different types of electromechanical sensors, along with a set of signal processing algorithms suited to the extraction of multiple hemodynamic parameters were developed. Two major groups of devices were designed depending on the cardiovascular risk marker to be assessed. The first group, focused on local arterial stiffness evaluation, explored an innovative double headed probe configuration of acoustic or piezoelectric (PZ) sensors for the measurement of pulse wave velocity (PWV) and other relevant time-based indices, in a short segment of the carotid artery. The other main group, centered on the continuous assessment of arterial blood pressure (ABP) and arterial pressure waveform (APW), also at the carotid artery, used a vibrator-accelerometer unit mounted in a common support that enabled the accelerometer to sense the produced vibrations, attenuated and modulated in amplitude when in mechanical contact with the vessel wall. The developed prototypes were extensively characterized in test bench systems, purposely built and capable of reproducing the variability of a wide range of clinically relevant situations, as well as in in vivo conditions. Regarding local arterial stiffness evaluation, the first and second generations of developed prototypes presented good accuracy in time resolution experiments on elastic tubes at the test bench. Cross-correlation algorithm exhibited the capability of measuring high PWVs (≈ 19 ms-1 and 14 ms-1) with relative errors and coefficients of variation lower than 10 % for the different prototypes. The acquired signals proved to be robust and repeatable, not suffering from crosstalk effect. The results obtained in a pre-clinical validation trial of twenty healthy subjects with the second generation of prototypes were very satisfactory, demonstrating that the mean carotid PWVs obtained were linearly and strongly correlated and were in agreement with other reference studies. Additionally, the ability to reproduce distinct wave pressure profiles using the PZs probes was also shown, either using the demodulation algorithm-based process or a special circuit for electronic integration. Concerning APW and ABP assessment, the demodulation process yielded excellent results in recovering the morphology of pressure wave in test bench and in in vivo conditions. For the two developed prototypes, several waveforms were accurately extracted from the acceleration, current or power modulated carriers using the envelope and product detector algorithms. It was possible to reproduce the pressure waveform for successive higher applanation positions of the elastic tube at the test bench with a root mean square error of 2.4 ± 0.51 %, when considering the best extracting method. The effectiveness of a novel calibration method focused on the use of empirical curves which convert acceleration into pressure was also demonstrated. Through the conservation of the acceleration carrier amplitude, it was possible to determine the maximum, minimum, mean and pulse pressure values with relative errors lower than 10 % in bench conditions. Also, the mean pressure differences between the latest prototype and the reference system were, on average, ≤ 5 ± 8 mmHg, satisfying the accuracy criteria of clinically validated ABP devices. Although clinical validation studies are still required, the global results obtained in this work for the two major types of prototypes provide great prospects regarding their use as valid alternatives to currently available systems, both in clinical and research settings

Non-invasive vascular assessment using photoplethysmography

Photoplethysmography (PPG) has become widely accepted as a valuable clinical tool for performing non-invasive biomedical monitoring. The dominant clinical application of PPG has been pulse oximetry, which uses spectral analysis of the peripheral blood supply to establish haemoglobin saturation. PPG has also found success in screening for venous dysfunction, though to a limited degree. Arterial Disease (AD) is a condition where blood flow in the arteries of the body is reduced,a condition known as ischaernia. Ischaernia can result in pain in the affected areas, such as chest pain for an ischearnic heart, but does not always produce symptoms. The most common form of AD is arteriosclerosis, which affects around 5% of the population over 50 years old. Arteriosclerosis, more commonly known as 'hardening of the arteries' is a condition that results in a gradual thickening, hardening and loss of elasticity in the walls of the arteries, reducing overall blood flow. This thesis investigates the possibility of employing PPG to perform vascular assessment, specifically arterial assessment, in two ways. PPG based perfusion monitoring may allow identification of ischaernia in the periphery. To further investigate this premise, prospective experimental trials are performed, firstly to assess the viability of PPG based perfusion monitoring and culminating in the development of a more objective method for determining ABPI using PPG based vascular assessment. A complex interaction between the heart and the connective vasculature, detected at the measuring site, generates the PPG signal. The haemodynamic properties of the vasculature will affect the shape of the PPG waveform, characterising the PPG signal with the properties of the intermediary vasculature. This thesis investigates the feasibility of deriving quantitative vascular parameters from the PPG signal. A quantitative approach allows direct identification of pathology, simplifying vascular assessment. Both forward and inverse models are developed in order to investigate this topic. Application of the models in prospective experimental trials with both normal subjects and subjects suffering PVD have shown encouraging results. It is concluded that the PPG signal contains information on the connective vasculature of the subject. PPG may be used to perform vascular assessment using either perfusion based techniques, where the magnitude of the PPG signal is of interest, or by directly assessing the connective vasculature using PPG, where the shape of the PPG signal is of interest. it is argued that PPG perfusion based techniques for performing the ABPI diagnosis protocol can offer greater sensitivity to the onset of PAD, compared to more conventional methods. It is speculated that the PPG based ABPI diagnosis protocol could provide enhanced PAD diagnosis, detecting the onset of the disease and allowing a treatmenpt lan to be formed soonert han was possible previously. The determination of quantitative vascular parameters using PPG shape could allow direct vascular diagnosis, reducing subjectivity due to interpretation. The prospective trials investigating PPG shape analysis concentrated on PVD diagnosis, but it is speculated that quantitative PPG shaped based vascular assessment could be a powerful tool in the diagnosis of many vascular based pathological conditions

Medical Devices Information Systems in Primary Care

People who suffer from chronic diseases are becoming more involved in remote monitoring processes each year. The market acceptance of remote care programmes, connecting patients through medical devices as part of the treatment regime, is spreading worldwide. Healthcare providers use medical devices to monitor, in various ways, the chronically ill population, namely people with diabetes and hypertension. However, most hospital and service provider information systems do not conform to the same important data standards, making interoperability and information sharing difficult. In this sense, the Multimorbidity Health Information System (METHIS) project is a multidisciplinary, goal-oriented, design-science-based intervention aiming to improve physician-patient communication and patient engagement. It focuses on multimorbidity and ageing, encompassing patients with more than one chronic disease and over 65 years old. The proposed solution is a Clinical Medical Devices Information (CMDI) system and data model which contains standardised information about chronic patients, medical devices and other data sets to be included in the METHIS System. With this framework, the system can perform consistently and reliably while meeting all relevant regulatory requirements or standards. Based on this dissertation and the METHIS project’s complementary work, implementing the CMDI in various Family Health Unit (FHU) in Portugal will make it possible to combat the diversity and loss of telemonitoring information.A cada ano, os doentes crónicos estão mais envolvidos em processos de telemonitorização. A aceitação pelo mercado de programas de cuidados à distância, ligando doentes através de dispositivos médicos como parte do regime de tratamento, está a espalhar-se por todo o mundo. Os prestadores de cuidados de saúde utilizam dispositivos médicos para monitorizar, de várias formas, a população cronicamente doente, nomeadamente as pessoas com diabetes e hipertensão arterial. No entanto, a maioria dos sistemas de informação dos hospitais e prestadores de serviços não estão em conformidade com as mesmas normas, o que dificulta a interoperabilidade e a partilha de informação. Neste sentido, o projeto METHIS é uma intervenção multidisciplinar, baseada em Design Science, que visa melhorar a comunicação entre médico e doente e o envolvimento do mesmo. Tem como foco a multimorbidade e o envelhecimento, englobando doentes com várias doenças crónicas e com idade superior a 65 anos. A solução proposta é um sistema e o correspondente modelo de dados CMDI que contém informação padronizada sobre doentes crónicos, dispositivos médicos e outros conjuntos de dados a serem incluídos no Sistema METHIS. Com este modelo de dados, o sistema possui a informação para poder funcionar de forma consistente e fiável, cumprindo todos os requisitos ou normas regulamentares relevantes. Com base nesta dissertação e no trabalho complementar do projeto METHIS, a implementação da base de dados CMDI em vários Unidades de Saúde em Portugal tornará possível combater a diversidade e a perda de informação na telemonitorização

The design and evaluation of discrete wearable medical devices for vital signs monitoring

The observation, recording and appraisal of an individual’s vital signs, namely temperature, heart rate, blood pressure, respiratory rate and blood oxygen saturation (SpO2), are key components in the assessment of their health and wellbeing. Measurements provide valuable diagnostic data, facilitating clinical diagnosis, management and monitoring. Respiratory rate sensing is perhaps the most under-utilised of all the vital signs, being routinely assessed by observation or estimated algorithmically from respiratory-induced beat-to-beat variation in heart rate. Moreover there is an unmet need for wearable devices that can measure all or most of the vital signs. This project therefore aims to a) develop a device that can measure respiratory rate and b) develop a wearable device that can measure all or most of the vital signs. An accelerometer-based clavicular respiratory motion sensor was developed and compared with a similar thoracic motion sensor and reference using exhalatory flow. Pilot study results established that the clavicle sensor accurately tracked the reference in monitoring respiratory rate and outperformed the thoracic device. An Ear-worn Patient Monitoring System (EPMS) was also developed, providing a discrete telemonitoring device capable of rapidly measuring tympanic temperature, heart rate, SpO2 and activity level. The results of a comparative pilot study against reference instruments revealed that heart rate matched the reference for accuracy, while temperature under read (< 1°C) and SpO2 was inconsistent with poor correlation. In conclusion, both of the prototype devices require further development. The respiratory sensor would benefit from product engineering and larger scale testing to fully exploit the technology, but could find use in both hospital and community-based The design and evaluation of discrete wearable medical devices for vital signs monitoring DG Pitts ii Cranfield University monitoring. The EPMS has potential for clinical and community use, having demonstrated its capability of rapidly capturing and wirelessly transmitting vital signs readings. Further development is nevertheless required to improve the thermometer probe and resolve outstanding issues with SpO2 readings