A Clinical Trial of the Effect of a Blood Leakage Detection Device for Patients during Hemodialysis.

In hemodialysis, vascular access is usually achieved through an arteriovenous fistula, and a dislodged needle can cause varying degrees of injury to patients. In severe cases, the loss of blood can prove to be fatal. This study proposed a blood leakage detection device for patients during hemodialysis (HD). First, the device was tested on a phantom arm, and later in a clinical test on patients receiving HD. The thoughts of the patients and the nursing staff involved were surveyed before and after the introduction of the device. Analysis of the results indicated that the device achieved 100% and 98.9% accuracy rates on the phantom arm test and clinical test, respectively. The results suggested that patients believed the device could reduce their mental anxiety, and the nursing staff considered the device reliable and that it would enhance the quality of care. The proposed detection device can be extended to similar applications for preventing catheter dislodgement, and to improve patient safety and reduce the stress of clinical nursing staff.

Development of an AVF Stenosis Assessment Tool for Hemodialysis Patients Using Robotic Ultrasound System.

With the aging population and lifestyle changes, the number of hemodialysis (HD) patients increases year by year. The arteriovenous fistula (AVF) is the gold standard vascular access used to access the blood for HD treatment. Since the status of stenosis affects HD efficiency, current clinical practices usually use a Doppler ultrasound imaging system to assess the parameters of the stenosis, such as the degree of stenosis (DOS). Unfortunately, this is a very time-consuming task. Furthermore, it is difficult to stably maintain the ultrasound probe for a prolonged period to give doctors clearer or reproducible images. In this study, a robotic ultrasound system (RUS) with ultrasound sequential imaging analysis was designed to evaluate the DOS of the AVF. The sequential imaging analysis was capable of image smoothing and vessel boundary detection. It enabled clinicians to mark the thickness of the plaque for further processing. Finally, the system was used to reconstruct 3D models of fistulas and calculated the DOS for clinical assessment. We also designed a pressure sensing module attached to the ultrasound probe to prevent the probe from coming loose, vibrating, and exerting abnormal pressure on the skin. In the phantom test, the results showed that the error of the DOS that was calculated by RUS was less than 3%. The results of clinical trials obtained from ten patients show that the error between the RUS and clinicians' measurement was about 10% and had a highly linear correlation (R Square > 0.95). In addition, the reproducibility error was about 3% and could effectively save about 46% of the time during clinical examinations.

Substitution-rate based screening model to assess stenosis progression in experimental stenotic arteriovenous grafts.

An arteriovenous graft (AVG) has a higher patency rate in stenosis progression at the venous anastomosis site, which causes coexisting inflow and outflow stenoses. This leads to increases in blood pressure, flow velocity, and flow resistance, resulting in hemodialysis (HD) vascular access dysfunction from early clots and thrombosis to the progression of coexisting stenoses. To prevent vascular access complications such as inflow or outflow stenoses, this study proposes a novel examination method in an experimental AVG system using a substitution-rate based screening model. In our practical measurements, we found that inflow and outflow channeled through a narrowed access indicated both pressure and resistance differences as the degree of stenosis (DOS) gradually increased. A substitution-rate matrix was conducted to replace bilateral pressure variations, while a transition probability matrix was calculated. Differences in transition probabilities were then used to distinguish between normal conditions and flow instabilities using the distance estimation method. The joint probability decayed from < 0.81 to 0.00 could be specified to identify the progression in stenosis levels from a DOS% = 50.0-95.0%. Average joint probabilities were found to be inversely related with the DOS using a non-linear regression (R>2 0.90). Hence, the joint probability could be specified as a critical threshold, < 0.81, to identify the severity stenosis level, DOS% ⩾ 70%, in the assessment of coexisting inflow and outflow stenoses. Experimental results suggest that the proposed model is superior to hemodynamic analysis and traditional intelligent method, and can be used for dysfunction screening during HD treatment.

Bilateral photoplethysmography for arterial steal detection in arteriovenous fistula using a fractional-order decision-making quantizer.

As inflow and outflow stenoses worsen, both flow resistance and pressure increase in the stenotic vascular access. During dialysis, when blood flow decreases, it may retrograde from the peripheral artery through the palmar arch to the arterial anastomosis site. Arterial steal syndrome (ASS) causes distal hypoperfusion, resulting in hand ischemia or extremity pain and edema. Hence, this study proposes the bilateral photoplethysmography (PPG) for ASS detection in arteriovenous fistulas. The decision-making quantizer utilizes the fractional-order feature extraction method and a non-cooperative game (NCG) framework to evaluate the ASS risk level. Bilateral asynchronous PPG signals have significant differences in the rise time and amplitude in relation to the degree of stenosis. The fractional-order self-synchronization error formulation is a feature extraction method used to quantify bilateral differences in blood flow changes between the dexter and sinister PPG signals. The NCG model as a method of decision-making is then employed to evaluate the ASS risk level. Using an acoustic Doppler measurement, the resistive (Res) index is also used to evaluate the vascular access stenosis at the arterial anastomosis site. In contrast with alternative methods including the high-sensitivity C-reactive protein level or Res index, our experimental results indicate that the proposed decision-making quantizer is more efficient in preventing ASS during hemodialysis treatment.

Novel Wearable Device for Blood Leakage Detection during Hemodialysis Using an Array Sensing Patch.

Hemodialysis (HD) is a clinical treatment that requires the puncturing of the body surface. However, needle dislodgement can cause a high risk of blood leakage and can be fatal to patients. Previous studies proposed several devices for blood leakage detection using optical or electrical techniques. Nonetheless, these methods used single-point detection and the design was not suitable for multi-bed monitoring. This study proposed a novel wearable device for blood leakage monitoring during HD using an array sensing patch. The array sensing patch combined with a mapping circuit and a wireless module could measure and transmit risk levels. The different risk levels could improve the working process of healthcare workers, and enhance their work efficiency and reduce inconvenience due to false alarms. Experimental results showed that each point of the sensing array could detect up to 0.1 mL of blood leakage and the array sensing patch supports a risk level monitoring system up to 8 h to alert healthcare personnel of pertinent danger to the patients.

An equivalent astable multivibrator model to assess flow instability and dysfunction risk in in-vitro stenotic arteriovenous grafts.

Narrowed vessel accesses produce blood flow changes, and induce flow instability and vessel wall vibration, resulting in blood pressure, flow velocity, and flow resistance increases. The vessel wall vibrates and propagates the low axial blood flow, as representing the resistance (R) to blood flow. The compliance is a blood pressure-blood volume relation, representing the systole and diastole capacity of the blood vessel. These dynamic behaviors increase blood flow resistances and reduce blood vessel compliances. Vibration phenomena result on the elastic vessel walls and induce simple harmonic motion due to transverse vibration pressure (TVP). The rise time, amplitude, and pulse duration of transverse waves are determined by the flow resistances (R) and vessel compliances (C). Thus, a stenotic arteriovenous access has high resistance and low compliance, which can be expressed an astable multivibrator as an equivalent model consisting of a lumped resistor (R) and a lumped capacitor (C). TVP's oscillation frequency, rise time, and amplitude are determined by the flow resistances and vessel compliances. Hence, an astable multivibrator is used to model TVP parameters to estimate negative time constants, τ=(R× C), which are used to evaluate the flow instability and the dysfunction risk in in-vitro arteriovenous grafts (AVGs). Experimental results show the average negative time constants have the positive correlation as the degree of stenosis (DOS) increases (R2 = 0.8944), and their variations with the flow resistance and vessel compliance are also validated. Positive pole values, s=(-1/τ), are used to show that the force responses of the vessel walls grow in a finite time, 0.5415 ± 7.60 × 10-3 sec, and the equivalent model would be also unstable as DOS increases (R2 = 0.8802). By comparison with hemodynamic analysis, the finding of proposed model can be further carried out for screening AVG dysfunction risk during hemodialysis treatment.

Assistive technology using integrated flexible sensor and virtual alarm unit for blood leakage detection during dialysis therapy.

Blood leakages and blood loss are both serious complications during dialysis therapies. According to dialysis survey reports, these events are life-threatening issues for nephrology nurses, medical staff, and patients. When venous needle dislodgement occurs, it takes only <2.5 min of reaction time for blood loss in an adult patient, resulting in mortality. As an early-warning design, a wireless assistive technology using an integrated flexible sensor and virtual alarm unit was developed to detect blood leakage during dialysis therapies. The flexible sensor was designed using a screen print technique with printing electronic circuits on a plastic substrate. A self-organising algorithm was used to design a virtual alarm unit, consisting of a virtual direct current grid and a virtual alarm driver. In other words, this warning device was employed to identify the blood leakage levels via wireless fidelity wireless network in cloud computing. The feasibility was verified, and commercialisation designs can also be implemented in an embedded system.

Detection of venous needle dislodgement during haemodialysis using fractional order shape index ratio and fuzzy colour relation analysis.

Venous needle dislodgement (VND) is a life-threatening complication during haemodialysis (HD) treatment. When VND occurs, it only takes a few minutes for blood loss in an adult patient. According to the ANNA (American Nephrology Nurses' Association) VND survey reports, VND is a concerning issue for the nephrology nurses/staff and patients. To ensure HD care and an effective treatment environment, this Letter proposes a combination of fractional order shape index ratio (SIR) and fuzzy colour relation analysis (CRA) to detect VND. If the venous needle drops out, clinical examinations show that both heart pulses and pressure wave variations have a low correlation at the venous anatomic site. Therefore, fractional order SIR is used to quantify the differences in transverse vibration pressures (TVPs) between the normal condition and meter reading. Linear regression shows that the fractional order SIR has a high correlation with the TVP variation. Fuzzy CRA is designed in a simple and visual message manner to identify the risk levels. A worst-case study demonstrated that the proposed model can be used for VND detection in clinical applications.

Bilateral photoplethysmography analysis for arteriovenous fistula dysfunction screening with fractional-order feature and cooperative game-based embedded detector.

The bilateral photoplethysmography (PPG) analysis for arteriovenous fistula (AVF) dysfunction screening with a fractional-order feature and a cooperative game (CG)-based embedded detector is proposed. The proposed detector uses a feature extraction method and a CG to evaluate the risk level for AVF dysfunction for patients undergoing haemodialysis treatment. A Sprott system is used to design a self-synchronisation error formulation to quantify the differences in the changes of blood volume for the sinister and dexter thumbs' PPG signals. Bilateral PPGs exhibit a significant difference in rise time and amplitude, which is proportional to the degree of stenosis. A less parameterised CG model is then used to evaluate the risk level. The proposed detector is also studied using an embedded system and bilateral optical measurements. The experimental results show that the risk of AVF stenosis during haemodialysis treatment is detected earlier.

Dysfunction Screening in Experimental Arteriovenous Grafts for Hemodialysis Using Fractional-Order Extractor and Color Relation Analysis.

In physical examinations, hemodialysis access stenosis leading to dysfunction occurs at the venous anastomosis site or the outflow vein. Information from the inflow stenosis, such as blood pressure, pressure drop, and flow resistance increases, allows dysfunction screening from the stage of early clots and thrombosis to the progression of outflow stenosis. Therefore, this study proposes dysfunction screening model in experimental arteriovenous grafts (AVGs) using the fractional-order extractor (FOE) and the color relation analysis (CRA). A Sprott system was designed using an FOE to quantify the differences in transverse vibration pressures between the inflow and outflow sites of an AVG. Experimental analysis revealed that the degree of stenosis (DOS) correlated with an increase in fractional-order dynamic errors (FODEs). Exponential regression was used to fit a non-linear curve and can be used to quantify the relationship between the FODEs and DOS (R (2) = 0.8064). The specific ranges were used to evaluate the stenosis degree, such as DOS: <50, 50-80, and >80%. A CRA-based screening method was derived from the hue angle-saturation-value color model, which describes perceptual color relationships for the DOS. It has a flexibility inference manner with color visualization to represent the different stenosis degrees, which has average accuracy >90% superior to the traditional methods. This in vitro experimental study demonstrated that the proposed model can be used for dysfunction screening in stenotic AVGs.

Residual stenosis estimation of arteriovenous grafts using a dual-channel phonoangiography with fractional-order features.

The residual stenosis estimation of an arteriovenous shunt is a valuable for evaluating outcomes of percutaneous transluminal angioplasty (PTA) treatment and surgical revision. This paper proposes a dual-channel phonoangiography (PCG) with fractional-order features to estimate the residual of stenosis estimation of arteriovenous shunt. The auscultation technique provides a noninvasive tool to monitor the degrees of arteriovenous grafts (AVGs). Then, support methods, such as the Burg autoregressive (AR) method and self-synchronization error formulation (SSEF), are used to extract fractional-order features between the loop site (L-site) and venous anastomosis site (V-site). Using 2-D patterns (nonlinear mapping), a generalized regression neural network (GRNN) is designed as a nonlinear estimate model to indicate the outcome of surgical revision or AVG stenosis upon routine monthly examinations. For 42 long-term follow-up patients, the results of examination show the proposed GRNN-based screening model efficiently estimates residual stenosis.

Multiple-site hemodynamic analysis of Doppler ultrasound with an adaptive color relation classifier for arteriovenous access occlusion evaluation.

This study proposes multiple-site hemodynamic analysis of Doppler ultrasound with an adaptive color relation classifier for arteriovenous access occlusion evaluation in routine examinations. The hemodynamic analysis is used to express the properties of blood flow through a vital access or a tube, using dimensionless numbers. An acoustic measurement is carried out to detect the peak-systolic and peak-diastolic velocities of blood flow from the arterial anastomosis sites (A) to the venous anastomosis sites (V). The ratio of the supracritical Reynolds (Re(supra)) number and the resistive (Res) index quantitates the degrees of stenosis (DOS) at multiple measurement sites. Then, an adaptive color relation classifier is designed as a nonlinear estimate model to survey the occlusion level in monthly examinations. For 30 long-term follow-up patients, the experimental results show the proposed screening model efficiently evaluates access occlusion.

Dual-wavelength GaN-based LEDs grown on truncated hexagonal pyramids formed by selective-area regrowth on Si-implanted GaN templates.

GaN-based blue light-emitting diodes (LEDs) with micro truncated hexagonal pyramid (THP) array were grown on selective-area Si-implanted GaN (SIG) templates. The GaN epitaxial layer regrown on the SIG templates exhibited selective growth and subsequent lateral growth to form the THP array. The observed selective-area growth was attributed to the different crystal structures between the Si-implanted and implantation-free regions. Consequently, LEDs grown on the GaN THP array emitted broad electroluminescence spectra with multiple peaks. Spatially resolved cathodoluminescence revealed that the broad spectra originated from different areas within each THP. Transmission electron microscopy showed the GaN-based epitaxial layers, including InGaN/GaN multi-quantum wells regrown at different growth rates (or with different In content in the InGaN wells) between the semi-polar and c-face planes of each THP.