US Device Research Articles

The relationship between sarcopenia, sarcopenia related quality of life and ultrasound findings of the rectus femoris muscle in older outpatients.

Skeletal muscle ultrasonography stands out as a promising method for detecting sarcopenia. We aimed to evaluate the relationship between sarcopenia, sarcopenia related quality of life and US findings of the Rectus Femoris muscle. A total of 300 older individuals were included in this cross-sectional study. Sarcopenia was diagnosed according to the European Working Group on Sarcopenia in Older People 2 criteria. Rectus F muscle thickness, cross-sectional area, fascicle length, pennation angle, stiffness and echogenicity were measured by an experienced radiologist using a B-mode US device. Quality of life was determined with the Sarcopenia- Quality of life questionnaire. Correlation analysis, receiver operating analysis, sensitivity and specificity analysis were performed. The median age of participants was 72. 191 (63.9%) and 109 (36.1%) of the participants were male and female, respectively. The prevalence of sarcopenia was 15.6%. Fascicle length, cross-sectional area and thickness showed the highest sensitivity (81%) and specificity (87%) for men. Fascicle length and pennation angle showed the highest sensitivity (87%) and specificity (66%) for women. Rectus Femoris ultrasound parameters differed across SarQoL quartiles, and higher Sarcopenia- Quality of life scores were associated with better ultrasound parameters. All ultrasound parameters had positive correlations with Sarcopenia- Quality of life. Different Rectus Femoris ultrasound parameters are useful for detecting sarcopenia according to gender. A combination of these parameters can increase diagnosis accuracy. Ultrasound parameters are associated with sarcopenia related quality of life.

Three-dimensional ultrasound to investigate synovitis in first carpometacarpal osteoarthritis: A feasibility study.

Synovitis is one of the defining characteristics of osteoarthritis (OA) in the carpometacarpal (CMC1) joint of the thumb. Quantitative characterization of synovial volume is important for furthering our understanding of CMC1 OA disease progression, treatment response, and monitoring strategies. In previous studies, three-dimensional ultrasound (3-D US) has demonstrated the feasibility of being a point-of-care system for monitoring knee OA. However, 3-D US has not been tested on the smaller joints of the hand, which presents unique physiological and imaging challenges. To develop and validate a novel application of 3-D US to monitor soft-tissue characteristics of OA in a CMC1 OA patient population compared to the current gold standard, magnetic resonance imaging (MRI). A motorized submerged transducer moving assembly was designed for this device specifically for imaging the joints of the hands and wrist. The device used a linear 3-D scanning approach, where a 14L5 2-D transducer was translated over the region of interest. Two imaging phantoms were used to test the linear and volumetric measurement accuracy of the 3-D US device. To evaluate the accuracy of the reconstructed 3-D US geometry, a multilayer monofilament string-grid phantom (10mm square grid) was scanned. To validate the volumetric measurement capabilities of the system, a simulated synovial tissue phantom with an embedded synovial effusion was fabricated and imaged. Ten CMC1 OA patients were imaged by our 3-D US and a 3.0 T MRI system to compare synovial volumes. The synovial volumes were manually segmented by two raters on the 2D slices of the 3D US reconstruction and MR images, to assess the accuracy and precision of the device for determining synovial tissue volumes. The Standard Error of Measurement and Minimal Detectable Change was used to assess the precision and sensitivity of the volume measurements. Paired sample t-tests were used to assess statistical significance. Additionally, rater reliability was assessed using Intra-Class Correlation (ICC) coefficients. The largest percent difference observed between the known physical volume of synovial extrusion in the phantom and the volume measured by our 3D US was 1.1% (p-value=0.03). The mean volume difference between the 3-D US and the gold standard MRI was 1.78% (p-value=0.48). The 3-D US synovial tissue volume measurements had a Standard Error Measurement (SEm ) of 11.21mm3 and a Minimal Detectible Change (MDC) of 31.06mm3 , while the MRI synovial tissue volume measurements had an SEM of 16.82mm3 and an MDC of 46.63mm3 . Excellent inter- and intra-rater reliability (ICCs=0.94-0.99) observed across all imaging modalities and raters. Our results indicate the feasibility of applying 3-D US technology to provide accurate and precise CMC1 synovial tissue volume measurements, similar to MRI volume measurements. Lower MDC and SEm values for 3-D US volume measurements indicate that it is a precise measurement tool to assess synovial volume and that it is sensitive to variation between volume segmentations. The application of this imaging technique to monitor OA pathogenesis and treatment response over time at the patient's bedside should be thoroughly investigated in future studies.

Differences in ultrasound elevational beam width (slice thickness) between popular handheld devices

BackgroundHandheld ultrasound devices are increasingly used by medical professionals for bedside ultrasound-guided interventions. Especially for vascular access procedures, the width of the imaging plane, known as the slice thickness or elevational beam width is a prominent source for misinterpretation. A wide slice thickness can lead to the interpretation that 2 objects (i.e. needle and vessel) are on the same plane while in fact they are not and thereby negatively influencing the performance of in-plane ultrasound-guided interventions. Therefore, the beam profiles of three popular handheld US devices are tested and compared to a conventional US device. MethodsThe GE VScan, Philips Lumify and Butterfly IQ ​+ ​are tested using a slice phantom to determine the slice thickness. For comparison, a Philips Affiniti machine was investigated. Both linear and curved array settings were analyzed. In a slice phantom, a diffuse scattering plane at an angle of exactly 45° is scanned. For each imaging depth, the vertical height of the imaged rectangle corresponds to the slice thickness at that depth. Main resultsFor the linear array transducers, the focus depth ranges from 1.5 to 3.5 cm. At the focus depth, all transducers have a reasonable slice thickness of approximately 1 mm. More superficially, the slice thickness varies between 1 and 4 mm. The curved array probes have larger focus depths, ranging from 2.7 to 7.3 cm. The slice thickness at focus depth varies between 1.4 and 3.8 mm, but at 2 cm depth is even more than 5 mm. ConclusionsThe slice thickness of handheld ultrasound transducers varies between the different devices, and can be suboptimal for superficial in-plane ultrasound-guided interventions. The larger slice thickness of the curved array settings may complicate in-plane guidance. Handheld ultrasound users should be aware of the beam characteristics of their devices to optimize guidance for interventions.

Using High-Resolution Ultrasound to Assess Post-Facial Paralysis Synkinesis-Machine Settings and Technical Aspects for Facial Surgeons.

Background: Synkinesis of the facial musculature is a detrimental sequalae in post-paralytic facial palsy (PPFP) patients. Detailed knowledge on the technical requirements and device properties in a high-resolution ultrasound (HRUS) examination is mandatory for a reliable facial muscle assessment in PPFP patients. We therefore aimed to outline the key steps in a HRUS examination and extract an optimized workflow schema. Methods: From December 2020 to April 2021, 20 patients with unilateral synkinesis underwent HRUS. All HRUS examinations were performed by the first author using US devices with linear multifrequency transducers of 4–18 MHz, including a LOGIQ E9 and a LOGIQ S7 XDclear (GE Healthcare; Milwaukee, WI, USA), as well as Philips Affinity 50G (Philips Health Systems; Eindhoven, the Netherlands). Results: Higher-frequency and multifrequency linear probes ≥15 MHz provided superior imaging qualities. The selection of the preset program Small Parts, Breast or Thyroid was linked with a more detailed contrast of the imaging morphology of facial tissue layers. Frequency (Frq) = 15 MHz, Gain (Gn) = 25–35 db, Depth (D) = 1–1.5 cm, and Focus (F) = 0.5 cm enhanced the image quality and assessability. Conclusions: An optimized HRUS examination protocol for quantitative and qualitative facial muscle assessments was proposed.

Peculiarities of Design, Marking and Coding of US and NATO Chemical Munitions and Warfare Devices (Lecture)

The lecture is intended for training NBCD Corps’ specialists from both the Russian Federation and foreign states, dealing with the issues of chemical safety. The lecture highlights two topics: 1) peculiarities of design of US chemical munitions and warfare devices; 2) marking and coding of US and NATO chemical munitions and devices. The material presented in the lecture will allow for broadening the horizons and acquiring knowledge related to the peculiarities of design, marking and coding of US and NATO chemical munitions and warfare devices. In addition, the lecture provides a review of changes in the marking and coding of US and NATO chemical munitions and warfare devices. It also deals with the historical development of the system of chemical munitions marking and coding.

Adiposity Assessment with a Novel Portable Ultrasound Device

ObjectivesUltrasound (US) systems are increasingly being used to quantify total body and regional adiposity (Epub 2015. PMID: 26,740,255) along with providing estimates of muscle fat infiltration (echogenicity; Epub 2020. PMID: 33,111,338). The aim of the current study was to evaluate the feasibility of a small, relatively low-cost ultrasound device (ButterflyIQ; Butterfly Network, Guilford, CT) that interfaces with an iPad to assess total body fat quantified with dual-energy X-ray absorptiometry (DXA).MethodsParticipants were a convenience sample of 59 healthy adults who were diverse in age, ethnicity, and adiposity. Total and regional fat masses were measured using DXA (Hologic, Marlborough, MA). Fat thicknesses were taken using the Butterfly at two points on the right thigh. Echogenicity of the rectus femoris was also determined using ImageJ (NIH, Bethesda, MD). Regression analysis was used to evaluate the associations between US-derived fat thickness and DXA-measured total body and leg fat mass. Correlations were also examined between US echogenicity and phase angle at 50 kHz (InBody S10; Seoul, South Korea), an established method for estimating muscle quality.ResultsOf the 59 participants, 2 females and 1 male were excluded due to low US image quality. Mid-thigh US adipose tissue layer thickness showed the strongest correlations (R2s) with total and right leg fat mass: females, 0.80 and 0.87; males, 0.56 and 0.53 (all p < 0.001). Corresponding correlations at the third-thigh site were smaller in magnitude (0.68 and 0.79; 0.41 and 0.37). A significant (p < 0.05) inverse relationship (R2, 0.10) was present between US echogenicity and phase angle at 50 kHz.ConclusionsThe evaluated small and portable US device has the important potential to phenotype adiposity and muscle quality in clinical and field settings that lack availability of larger, more costly, and complex measurement systems.Funding SourcesThis work was partially supported by National Institutes of Health NORC Center Grants P30DK072476, Pennington/Louisiana; and P30DK040561, Harvard; and R01DK109008, Shape UP! Adults.

Learnability of ultrasound tongue imaging devices in speech-language pathology

Ultrasound tongue imaging has shown potential for speech-language pathologists (SLPs) to evaluate and treat persistent articulatory disorders. However, SLPs typically begin with low to no familiarity with ultrasound. Thus, this study investigated an important aspect of ultrasound device usability: learnability for SLPs. The project was funded by an NSERC Engage grant in partnership with Clarius Mobile Health. Twelve SLPs learned to use two ultrasound devices: a wireless device, provided by our partner Clarius, and a traditional device, to record clips of their or the experimenter’s tongue. They then completed a questionnaire (French translation of the System Usability Scale (Brooke, 1996)). Two expert judges evaluated the clips recorded by the SLPs for the choice of settings and the positioning of the probe. Results of the SUS show a better usability for the wireless device than the traditional device. SLPs appreciated the user-friendly tablet interface, possibly because they are already used to interacting with tablets. Clips analyses show a better choice of settings by the SLPs with the wireless device. The positioning of the probe, however, was better with the traditional device, possibly due to its smaller probe. In conclusion, US seems to have a good potential of usability in speech-language pathology, provided that SLPs receive training for US image interpretation. A traditional US device may require a longer learning period than a wireless model with tablet interface.

The Role of US Policymaking in the Emergence of a Digital Health Assemblage

ABSTRACT Promising to improve the quality of care while decreasing healthcare costs, digital health technologies (DHT) are welcomed as a solution to the challenges increasingly faced by healthcare systems in the global north. In recent years, tech developers, consultants, policymakers, and researchers in the US have heralded Big Tech entrepreneurs as driving the emergence of these technologies. However, apart from Silicon Valley visions of DHT, there are a range of regulations, devices, institutions, and practices constituting the DHT assemblage in the US. These include US policies following the global financial crisis of 2008 – such as the US' monetary policy, and the Health Information Technology for Economic and Clinical Health Act (HITECH Act) – and the enactment of the Patient Protection and Affordable Care Act (ACA). Accordingly, a more granular approach is required to understand the rise of DHT beyond these stereotypical ‘Silicon Valley’ accounts of the emergence of disruptive digital technologies. Careful attention on various, seemingly unrelated, policymaking events reveals how the unintended alignment of these US policy visions, regulations, devices, institutions, and practices have played an instrumental role in the successful emergence of DHT, while also impacting ongoing global developments of these technologies.

Learnability of ultrasound tongue imaging devices in speech-language pathology

Ultrasound tongue imaging has shown potential for speech-language pathologists (SLPs) to evaluate and treat persistent articulatory disorders. However, SLPs typically begin with low to no familiarity with ultrasound. Thus, this study investigated an important aspect of ultrasound device usability: learnability for SLPs. The project was funded by an NSERC Engage grant in partnership with Clarius Mobile Health. 12 SLPs learned to use two ultrasound devices: a wireless device, provided by our partner Clarius, and a traditional device, to record clips of their or the experimenter’s tongue. They then completed a questionnaire [French translation of the System Usability Scale (Brooke, 1996)]. Two expert judges evaluated the clips recorded by the SLPs for the choice of settings and the positioning of the probe. Results of the SUS show a better usability for the wireless device than the traditional device. SLPs appreciated the user-friendly tablet interface, possibly because they are already used to interacting with tablets. Clips analyses show a better choice of settings by the SLPs with the wireless device. The positioning of the probe, however, was better with the traditional device, possibly due to its smaller probe. In conclusion, US seems to have a good potential of usability in speech-language pathology, provided that SLPs receive training for US image interpretation. A traditional US device may require a longer learning period than a wireless model with tablet interface.

Preparedness of Australasian emergency departments for point-of-care ultrasound in the COVID-19 pandemic.

IntroductionPoint‐of‐care ultrasound (POCUS) has been brought to the limelight again, with a surge in lung ultrasound in suspected COVID‐19 patients. This is due to POCUS superiority over chest X‐ray, equivalent efficacy to computerised tomography chest for COVID‐19 diagnosis and potential minimisation of cross‐infection. However, inadequate disinfection practices could make ultrasound machines a vector for disease transmission. This study, conducted during the early phase of the COVID‐19 pandemic, surveyed the preparedness of Australasian Clinicians for responsible POCUS practice within the Emergency Department (ED).MethodsAn anonymous online survey conducted from 20th April to 3rd June 2020 among emergency clinicians providing POCUS within Australasian EDs investigated preparedness to provide effective POCUS while minimising cross‐infection.ResultsThe survey received 171 responses and 116 being eligible for analysis. Most respondents (n = 96, 98%) had a separate ‘hot zone’ with a dedicated US device (n = 75, 77%), but lacked COVID‐19‐specific standard‐operating procedures (n = 51, 52%) or a designated safety and compliance officer (n = 36, 37%). Most clinicians (n = 86, 88%) were willing to perform ultrasound in highly infectious patients, despite poor formal training (n = 66, 67%) or COVID‐19‐specific lung protocols (n = 59, 60%). Most (n = 92, 93%) had access to appropriate low‐level disinfectant wipes but varied significantly in disinfection practice due to a lack of timely, formal or unified guidelines.ConclusionAustralasian EDs significantly lacked investment in education, training and protocols to conduct safe POCUS in the COVID‐19 pandemic. A framework with evidence‐based, logistically feasible protocols supporting safe emergency POCUS is required to deal with similar future infectious outbreaks.

How Pseudoscience Generated US Material and Device Regulations.

The images in the American Medical Association's Historic Health Fraud and Alternative Medicine Collection include quack devices from the early 20th century, which gave rise to regulatory and professional oversight.

POS1394 ACCURACY AND PERFORMANCE OF A HANDHELD ULTRASOUND DEVICE TO ASSESS ARTICULAR AND PERIARTICULAR PATHOLOGIES IN PATIENTS WITH INFLAMMATORY ARTHRITIS

Background:Handheld ultrasound (HHUS) devices have increasingly found their way into clinical practice due to several advantages (e.g. portability, significantly lower purchase cost). However, there is no evidence to date on the accuracy and performance of HHUS in patients with inflammatory arthritis (IA).Objectives:To assess accuracy and performance of a new HHUS machine in comparison to a conventional cart-based sonographic machine in patients with IA.Methods:Consecutive IA patients of our outpatient clinic with at least one tender and swollen joint in the 66/68 joint count were enrolled. US was performed on clinically affected joints with corresponding tendons/entheses using a cart-based sonographic device (“Samsung HS40”) and a HHUS device (“Butterfly iQ”) in standard scan positions. One blinded reader scored all images for the presence of following pathologic findings: erosions, bony enlargement, synovial hyperthrophy, joint effusion, bursitis, tenosynovitis and enthesitis. In addition, synovitis was graded (B Mode and power Doppler (PD)) by the 4-level EULAR-OMERACT scale [1]. To avoid bias by the blinded reader, who otherwise would have been tempted to identify pathological findings for each examined joint, we also included 67 joints of two healthy volunteers into the evaluation. We calculated the overall concordance and the concordance by type of joint and type of pathological finding between the two devices (percentage of observation pairs in which the same rating was given by both devices). The Cohen’s kappa coefficient (κ) with 95% bootstrap confidence intervals was used to assess the agreement between the two US devices. We also measured the time required for the US examination of one joint with both devices.Results:32 patients (20 rheumatoid arthritis, 10 psoriatic arthritis, 1 gouty arthritis, 1 systemic lupus erythematosus) were included in this study. Mean age of patients was 58.2±13.7 years, 63% were females. In total 186 joints were examined. The overall raw concordance in B-mode between the two devices was 97 %, with an overall κappa for agreement of 0.90, 95% CI (0.89, 0.94). No significant differences were found in relation to type of joint or pathological finding examined. The PD-mode of the HHUS device did not detect any PD-signal, whereas the cart-based device detected a PD-signal in 61 joints (33%). The portable device did not offer any time saving compared to the cart-based device (mean time in seconds per examined region: 47 seconds for the HHUS device versus 46.3 seconds for the cart-based device).Conclusion:The HHUS device “Butterfly iQ” has been shown to be accurate in the assessment of structural joint damage and inflammation in patients with IA, but only in B-mode. Significant improvements are still needed to reliable demonstrate blood flow detection by PD mode.

Validation of a three dimensional musculoskeletal ultrasound system for use in hands and wrists

Purpose: The effect of chronic synovitis on the progression of osteoarthritis pathology is a relatively new but supported concept in the fields of rheumatology and hand surgery that has been linked to pain and disability in patients. Currently, the gold standard for diagnosing synovitis in the wrists and hands is a clinical examination and the use of 2 dimensional (2D) musculoskeletal ultrasound imaging (US). Major limitations associated with this method are the lack of quantitative measurement tools available and the fact that physicians have to be able to mentally reconstruct the patient’s 3-dimensional anatomy from the 2-dimensional images provided. These limitations can be overcome by using a 3-dimensional ultrasound (3DUS) system to quantitatively measure the size of synovial hypertrophy, effusions, ganglions and osteophytes as well as having a 3D reconstruction of the patient’s hand. The aim of this work is to develop a 3D ultrasound system for imaging the hand and wrist. This paper reports on the development, geometric, and volumetric validation for wrist/hand 3D ultrasound imaging. Methods: A mechatronic wrist/hand imaging system was designed and created to operate with a conventional 2D US imaging system. The scanning system features a motor which contains a single integrated electromagnetic encoder that records the rotational position of the motor. This motor drives a lead screw which in turn moves the transducer, which is submerged in a water bath, along the linear axis to acquire a series of 2D images. The encoder information provides the software with the position of each 2D ultrasound frame. These conventional diagnostic 2D US images are then reconstructed into a 3D US images from a licensed ultrasound machine. The geometric validation of the system was done using a multi-layered monofilament grid phantom with spacings of 10 mm and the Euclidean distances between the wires were measured. The volumetric validation was conducted using a simulated synovial tissue phantom and the images were analyzed using 3D-Slicer to manually segment individual slices in the 3D image. These slices were then interpolated to construct a 3D segmentation of the phantom. This process was repeated over four days to test the intra-rater reliability of the system. The 3D volumes were compared to those found using magnetic resonance imaging (MRI) and the known volume of the agar phantom. Results: The largest error and variance recorded from the geometric validation measurements was 0.0856± 0.0087mm and was acquired from the reconstruction plane. The remaining linear measurement errors were all < 1%. The error between the mean phantom volume measurements and the known synovium phantom volume was 5.99% and 2.43% for the 3D US device and MRI respectively. Linear regression for volumetric measures revealed an R2 value of 0.4736 with a p-value of 0.20, revealing no significant correlation between the measurements made over the course of 4 days for the 3D US device. The percent difference in the volume measurements from the 3D US device and MRI was 0.814%. Conclusions: A mechatronic 3D ultrasound imaging system was developed for the wrist and hand. Successful geometric and volumetric validation demonstrates feasibility for implementation in a clinical setting. Current work evaluates system ability to accurately and quantitatively classify synovitis in first carpometacarpal joint and distal radial injury patients to investigate the relationship between chronic inflammation and the progression of osteoarthritis in patients.

Anatomic basis for a new ultrasound-guided, mini-invasive technique for release of the deep transverse metatarsal ligament.

IntroductionMorton's neuroma is an entrapment neuropathy of the third common plantar digital nerve, caused by the deep transverse metatarsal ligament (DTML). Minimally invasive or percutaneous surgery is a very common procedure, but surgical effectivity of this technique remains controversial. The goal of our study was to prove the effectiveness and safety of a new ultrasound‐guided technique for DTML‐release in a cadaver model.Materials, Methods, and ResultsThe DTML was visualized in 10 fresh frozen donated body to science‐feet (eight male and two females, five left and five right) using an US device (GE Logic R7; 13 MHz linear probe, Madrid, Spain). Consecutively, minimally invasive ultrasound‐guided surgery was performed. Exclusion criteria of the donated bodies to science were previous history of forefoot surgery and space occupying mass lesions. The complete release of the ligament was achieved in all specimens without damage of any important anatomical structures as proven by anatomical dissection.ConclusionsThe results of this study indicate that our novel approach of an ultrasound‐guided release of the DTML is safer and more effective compared to blind techniques. The DTML could reliably be visualized and securely cut through a dorsal, minimally invasive surgical incision of only 2 mm.

New US device versus imaging US to assess tumor-in-brain

BackgroundApplying ultrasonic imaging system during surgery requires the poring of saline, performing the measurement, and acquiring data from its display—which requires time and is highly “performer dependent,” i.e., the measure is of a subjective nature. A new ultrasonic device was recently developed that overcomes most of these drawbacks and was successfully applied during tumor-in-brain neurosurgeries. The purpose of this study was to compare the two types of US devices and demonstrate their properties.MethodsThe study was performed in the following stages: (i) an ex vivo experiment, where slices of the muscle and brain of a young porcine were laid one on top the other. Thicknesses and border depths were measured and compared, using the two types of US instruments. (ii) During human clinical neurosurgeries, tumor depth was compared by measuring it with both devices. (iii) Following the success of stages (i) and (ii), using solely the new US device, the tumor thickness was monitored while its resection.Correlation, Pearson’s coefficient, average, mean, and standard deviation were applied for statistical tests.ResultsA high correlation was obtained for the distances of tissue borders and for their respective thicknesses. Applying these ultrasonic devices during neurosurgeries, tumor depths were monitored with high similarity (87%), which was also obtained by Pearson’s correlation coefficient (0.44). The new US device, thanks to its small footprint, its remote measurement, and the capability of monitoring intraoperatively and in real-time, provides the approach to tumor’s border before its complete resection.ConclusionsThe new US device provides better accuracy than an ultrasonic imaging system; its data is objective; it enables to control the residual tumor thickness during its resection, and it is especially useful in restricted areas. These features were found of great help during a tumor-in-brain surgery and especially in the final stages of tumor’s resection.

Use of ultrasound guidance in central venous catheter placement by emergency physicians in Saudi Arabia.

Objectives:To determine the ultrasound guidance for central venous catheter (USG-CVC) placement rate of emergency physicians (EPs) in Kingdom of Saudi Arabia.Methods:A cross-sectional survey study regarding the respondents’ demographic profiles, formal and informal training in USG-CVC placement, experiences, and attitudes towards the procedure was emailed to all EPs registered with the Saudi Commission for Health Specialties (SCFHS) between October and December 2018.Results:In total, 234/350 SCFHS-registered EPs completed the survey; the response rate was 66.9%. Most respondents (70.5%) were board-certified in emergency medicine (EM). Ninety percent indicated that US device for CVC placement assistance was available. Most EPs (78.2%) had performed USG-CVC placement; the US usage rate correlated significantly with recent graduation from residency (p=0.048). In total, 83.3% received formal training during residency. Of the 234 respondents, 53.8% felt extremely comfortable with CVC placement with USG and 19.7% without USG (p<0.01). Nevertheless, most respondents desired further USG-CVC training.Conclusion:Despite existing evidence and a consensus on its superiority over the landmark technique, USG-CVC placement has not been adopted by a small proportion of EPs into clinical practice. Formal training, education, and institutional provision of permanent onsite US machines may address any barriers.

Enhancing Trigger Point Dry Needling Safety by Ultrasound Skin-to-Rib Measurement: An inter-Rater Reliability Study.

Dry needling (DN) is a minimally invasive treatment technique widely used by physical therapists to treat myofascial trigger points (MTrP). Even if its safety has been commonly declared and the majority of adverse events are considered mild, serious adverse events cannot be excluded and DN treatments of several trunk muscles can potentially result in pneumothorax. Ultrasound imaging (US) skin-to-rib measurement could ensure the safety of this treatment procedure. Therefore, the aim of this study was to determine the inter-rater reliability of depth measurement of different trunk muscles (i.e., rhomboid, lower trapezius, iliocostalis, and pectoralis major) between an expert and two novice physiotherapists. Skin-to-rib distance of 26 asymptomatic and normal weights subjects was consecutively, independently, and randomly measured for each muscle by the three examiners (1 expert and 2 novice physical therapists) with a handheld US wireless probe. Intraclass correlation coefficient (ICC3,k) and standard error of measurement (SEM) were used to assess inter-rater reliability. Inter-rater reliability of skin-to-rib measurements between the three examiners was good to excellent or excellent for every muscle, with an ICC3,k ranging from 0.92 and 0.98 (95% CI 0.86–0.99). The SEM never exceeded 10% of the skin-to-rib distance. In conclusion, skin-to-rib US measurements of the trunk muscles can be reliably performed by novice physical therapists using a handheld US device. These measures could be used as an innovative and reliable technique to improve the safety of some potential dangerous DN treatments.

P1185LUNG COMETS AND EVALUATION OF HYDRATION STATUS IN PERITONEAL DIALYSIS PATIENTS

Abstract Background and Aims Assessment of optimal hydration status in patients with end-stage renal disease (ESRD) on peritoneal dialysis (PD) is a challenge. Multiple diagnostic options to determine hydration status in PD patients are available. Multifrequency bioimpedance spectroscopy (MBIS) is a cheap, simple and non-invasive method of estimating body composition, including estimates of total body water (TBW), extracellular water (ECW), intracellular water (ICW) and the ratio between both spaces (ECW/ICW). Lung ultrasonography (LUS) and lung B-lines (lung comets) can be used for the evaluation of extravascular lung water. Ultrasound evaluation of inferior vena cava (UIVC) provides rapid, non-invasive assessment of a patient's hemodynamic and volume status. N-terminal pro-brain natriuretic peptide (NT-proBNP) is related to fluid status and fluid distribution. The aim of our study was to assess fluid status in PD patients comparing four different methods: MBIS, LUS, UIVC and NT-proBNP. Method We performed a single-centre cohort study in 19 PD patients. The body composition was measured using the portable whole-body MBIS device, Body Composition Monitor-BCM(®) (Fresenius Medical Care, Bad Homburg, Germany), LUS with portable US device (VScan, General Electrics Corporate), UIVC index with SonoSite US device. NT-proBNP was measured in a one-step sandwich chemiluminescent immunoassay (Dimension Vista® System 1500, Siemens Healthcare Diagnostics Inc., Newark, NJ, USA). Results The mean age of patients was 54 ± 10 years, mean dialysis vintage 53 (10-194) months, 63% were men. Thirteen (68.4%) patients had fluid overload (FO) &amp;gt; 1.1 L. Data of patients are presented in table 1. We found a statistically significant correlation between the number of lung comets and ECW/ICW ratio (r = 0.496, P = 0.031) and NT-proBNP (r = 0.759, P &amp;lt; 0.0001). In contrast, there was no significant correlation between the number of lung comets and UIVC (r = 0.221, P &amp;lt; 0.364). Conclusion According to our results, LUS with lung comets, MBIS with ECW/ICW ratio and NT-proBNP are useful and complementary methods for evaluation of fluid status in PD patients.

P0304POINT OF CARE ULTRASOUND IN NEPHROLOGY: THE SOONER THE BETTER!

Abstract Background and Aims Point of care ultrasound (POCUS) is performed at the bedsite of the patient by de treating clinician. In nephrology a particular situation is related to severly ill patients, immobilized with elevated creatinine, which can not be deffered to imaging investigations such as CT scan or MRI. Using a small portable device, important clinical problems can be solved in no time. Method We examined 360 out of 670 patients admitted to the nephrology departament in a period of one year. They were severely ill due to following pathologies: 35 severe sepsis with hypotension, 53 decompensated heart failure, 24 stroke, 248 with renal failure and acido-basic or electrolitic disturbances. Evaluation was made using a portable US device with a 10 MHz linear probe and 3.5 MHz convexe probe with abdomen and thoracic software. Diameter of inferior vena cava (IVC), respiratory collapse of IVC, effusions in pleura, pericardium or peritoneum, liver dimensions, kidneys and spleen were described. Results 31 out of 35 patients with hypotension had collapsed IVC, diameter less than 1cm, PPV 88.5%; 48 from 53 heart failure had enlarged IVC with reduced respiratory collapse, PPV 90.6% and 201 from 248 renal failure patients had kidney changes, 81.04%. As compared with standard diagnostic tools (echocardiography, native CT scan and clinical examination, Sensitivity was over 98% in all cases. Conclusion POCUS is a very usefull test for the rapid bed-site examination of kidney patients, were a rapid decision has to be made using a portable device. Sensitivity of the method proved to be comparable as with standard diagnostic tools.

Electrophysiology devices and the regulatory approval process within the U.S. FDA and abroad.

Almost all electrophysiology (EP) devices need to obtain premarket approval before they can be commercially sold and available for use in the community. The US Food and Drug Administration (FDA) has different paths to market approval depending on the intended use and the associated risks of the device. The European Union and Japan have device approval processes that have many similarities as well as differences to the US regulatory system. This paper describes some of the history and background of the US device approval process with an emphasis on EP devices. It provides an overview of the different regulatory pathways in the USA that are currently being utilized and contrasts them to the procedures often used in the European Union and in Japan. It also touches on the impact of the twenty-first Century Cures Act and how the balance between premarket and postmarket regulatory oversight is continually being examined and refined.