Invasive Devices Research Articles

Risk factors in acquiring multidrug-resistant Klebsiella pneumoniae infections in a hospital setting in Saudi Arabia

Over the last decades, the prevalence of multidrug-resistant (MDR) Klebsiella pneumoniae in clinical settings has increased progressively. This study determined the prevalence and risk factors associated with MDR K. pneumoniae infection among hospitalized patients in a referral hospital located in southern Saudi Arabia. A prospective cross-sectional study was conducted in King Abdullah Hospital from April 2021 to March 2022. K. pneumoniae (n = 211) bacteria were recovered from clinical samples of adult patients and examined for antibiotic susceptibility. Univariate and multivariate logistic regressions were applied to determine the factors associated with MDR K. pneumoniae infection. MDR K. pneumoniae strains was found in 66.8% (142/211) of the patients. Among MDR K. pneumoniae, the highest resistance rate was determined for ampicillin (100%), cefuroxime (97.9%), ceftriaxone (94.3%), and aztreonam (92.2%). The lowest resistance rate was determined for colistin (16.3%), and tigecycline (6.4%). Further, the patients’ gender, age group, intensive care unit (ICU) admission, invasive medical devices, and chronic illness were found to be significantly associated with MDR K. pneumoniae infection. The independent risk factors associated with MDR K. pneumoniae infection were the male gender (adjusted odds ratio [AOR] 2.107, 95% confidence interval CI 1.125‒3.945, p = 0.02), patients ≥ 65 years of age (AOR 1.905; CI 1.003‒3.616, p = 0.049), ICU admission (AOR 1.963; CI 1.033‒3.732, p = 0.04), diabetes (AOR 1.95; CI 1.02‒3.727, p = 0.043) and chronic obstructive pulmonary disease (AOR 7.172; CI 1.557‒33.032, p = 0.011). The study offered a vision of MDR K. pneumoniae infection in our setting and provided essential indications for further studies that may lead to the prevention and reduction of MDR bacteria.

Agreement between cardiac output estimation with a wireless, wearable pulse decomposition analysis device and continuous thermodilution in post cardiac surgery intensive care unit patients.

Pulse Decomposition Analysis (PDA) uses integration of the systolic area of a distally transmitted aortic pulse as well as arterial stiffness estimates to compute cardiac output. We sought to assess agreement of cardiac output (CO) estimation between continuous pulmonary artery catheter (PAC) guided thermodilution (CO-CCO) and a wireless, wearable noninvasive device, (Vitalstream, Caretaker Medical, Charlottesville, VA), that utilizes the Pulse Decomposition Analysis (CO-PDA) method in postoperative cardiac surgery patients in the intensive care unit. CO-CCO measurements were compared with post processed CO-PDA measurements in prospectively enrolled adult cardiac surgical intensive care unit patients. Uncalibrated CO-PDA values were compared for accuracy with CO-CCO via a Bland-Altman analysis considering repeated measurements and a concordance analysis with a 10% exclusion zone. 259.7h of monitoring data from 41 patients matching 15,583 data points were analyzed. Mean CO-CCO was 5.55L/min, while mean values for the CO-PDA were 5.73L/min (mean of differences +- SD 0.79 ± 1.11L/min; limits of agreement - 1.43 to 3.01L/min), with a percentage error of 37.5%. CO-CCO correlation with CO-PDA was moderate (0.54) and concordance was 0.83. Compared with the CO-CCO Swan-Ganz, cardiac output measurements obtained using the CO-PDA were not interchangeable when using a 30% threshold. These preliminary results were within the 45% limits for minimally invasive devices, and pending further robust trials, the CO-PDA offers a noninvasive, wireless solution to complement and extend hemodynamic monitoring within and outside the ICU.

Interspinous-Interbody Fusion via a Strictly Lateral Surgical Approach: A Biomechanical Stabilization Comparison to Constructs Requiring Both Lateral and Posterior Approaches.

Objective Lumbar fusion performed through lateral approaches is becoming more common. The interbody devices are generally supported by supplemental posterior fixation implanted through a posterior approach, potentially requiring a second incision and intraoperative repositioning of the patient. A minimally invasive lateral interspinous fixation device may eliminate the need for intraoperative repositioning and avoid disruption of the supraspinous ligament. The objective of this in vitrobiomechanical study was to investigate segmental multidirectional stability and maintenance of foraminal distraction of a lateral interspinous fixation device compared to commonly used pedicle screw and facet screw posterior fixation constructs when combined with lumbar interbody cages. Methods Six human cadaver lumbar spine specimens were subjected to nondestructive quasistatic loading in the following states: (1) intact; (2) interspinous fixation device alone and (3) with lateral interbody cage; (4) lateral lumbar interbody cage with bilateral pedicle screws; (5) lateral lumbar interbody cage with unilateral pedicle screws; and (6) lateral lumbar interbody cage with facet screws. Multidirectional pure bending in 1.5 Nm increments to 7.5 Nm, and 7.5 Nm flexion-extension bending with a 700 N compressive follower load were performed separately with optoelectronic segmental motion measurement. Relative angular motions of L2-L3, L3-L4, and L4-L5 functional spinal units were evaluated, and the mean instantaneous axis of rotation in the sagittal plane was calculated for the index level.Foraminal height was assessed during combined flexion-extension and compression loading for each test construct. Results All implant configurations significantly restricted flexion-extension motion compared with intact (p < 0.05). No significant differences were found in flexion-extension when comparing the different posterior implants combined with lateral lumbar interbody cages. All posterior fixation devices provided comparable neuroforaminal distraction and maintained distraction during flexion and extension. Conclusions When combinedwith lateral lumbar interbody cages, the minimally invasive lateral interspinous fixation device effectively stabilized the spine and maintained neuroforaminal distraction comparable to pedicle screw constructs or facet screws. These results suggest the lateral interspinous fixation device may provide a favorable alternative to other posterior systems that require patient repositioning during surgery and involve a greater disruption of native tissues.

Biophysiologic Monitoring for the Neurosurgical Patient.

Biophysiologic monitoring exists as a method of collecting objective information about the neurosurgical patient throughout their treatment and recovery process. Such data is crucial for an improved understanding of the disease processes while providing the surgeon additional clarity as they decipher the next best steps in decision-making and medical recommendations. In the current review article, the authors discuss the commonly used wearable and placeable monitoring devices and the biophysiological data that can be collected to monitor, as well as, assess the neurosurgical patient. Special focus is placed on invasive and non-invasive neurologic monitoring devices, but important and commonly used monitors for the rest of the body are also discussed as they relate to the neurosurgical patient. Last, the authors review new, as well as, upcoming devices and measurements to better analyze the neurosurgical patient's bodily function and physiologic status as needed. The synthesis of methods contained herein may provide meaningful guidance for neurosurgeons in effectively monitoring and treating their patients while also helping to guide their future efforts in patient biophysiologic monitoring developments within neurosurgery.

Risk Factors for Colonization With Extended-Spectrum Cephalosporin-Resistant and Carbapenem-Resistant Enterobacterales Among Hospitalized Patients in Kenya: An Antibiotic Resistance in Communities and Hospitals (ARCH) Study.

The spread of extended-spectrum cephalosporin-resistant Enterobacterales (ESCrE) and carbapenem-resistant Enterobacterales (CRE) represents a significant global public health threat. We identified putative risk factors for ESCrE and CRE colonization among patients in 1 urban and 3 rural hospitals in Kenya. During a January 2019 and March 2020 cross-sectional study, stool samples were collected from randomized inpatients and tested for ESCrE and CRE. The Vitek2 instrument was used for isolate confirmation and antibiotic susceptibility testing, and least absolute shrinkage and selection operator (LASSO) regression models were used to identify colonization risk factors while varying antibiotic use measures. Most (76%) of the 840 enrolled participants received ≥1 antibiotic in the 14 days preceding their enrollment, primarily ceftriaxone (46%), metronidazole (28%), or benzylpenicillin-gentamycin (23%). For LASSO models that included ceftriaxone administration, ESCrE colonization odds were higher among patients hospitalized for ≥3 days (odds ratio, 2.32 [95% confidence interval, 1.6-3.37]; P < .001), intubated patients (1.73 [1.03-2.91]; P = .009), and persons living with human immunodeficiency virus (1.70 [1.03-2.8]; P = .029). CRE colonization odds were higher among patients receiving ceftriaxone (odds ratio, 2.23 [95% confidence interval, 1.14-4.38]; P = .025) and for every additional day of antibiotic use (1.08 [1.03-1.13]; P = .002). While CRE colonization was strongly associated with ceftriaxone use and duration of antibiotic use, the odds of ESCrE colonization increased with exposure to the hospital setting and invasive medical devices, which may reflect nosocomial transmission. These data suggest several areas where hospitals can intervene to prevent colonization among hospitalized patients, both through robust infection prevention and control practices and antibiotic stewardship programs.

Comparative cohort analysis of pressure ulcer/injury in intensive care unit patients before and during the COVID-19 pandemic

COVID-19 has emerged as a global pandemic leading to an increase in hospitalization and intensive care unit (ICU) admissions worldwide. Due to severe acute respiratory distress syndrome (ARDS), many patients require prone positioning, which is associated with increased pressure ulcer/injury (PU/PI) incidence. COVID-19 pathophysiology may favor the occurrence of PU/PI due to hypoxemia, inflammatory status, and vasculopathy. This study aimed to compare the incidence of PU/PI in ICU patients before and during the COVID-19 pandemic. A retrospective cohort study was conducted at a university hospital in Brazil. Data from the medical charts of every adult patient admitted to ICU from March to July 2019 and the same period in 2020 were collected. The group from 2019 included 408 patients admitted due to multiple causes, and the group from 2020 included 229 patients admitted due to COVID-19 infection. The incidence of PU/PI was significantly higher in patients admitted in 2020 compared to 2019 (62,5 vs. 33,8%, respectively). Also, PU/PI location and severity have been different between groups, with the patients with COVID-19 (2020 group) more exposed to stage 3, 4, and non-stageable lesions, as well as more PU/PI on face skin and other less common locations. In conclusion, the COVID-19 pandemic has highlighted a higher PU/PI incidence. ICU patients were older during the pandemic, had higher body mass index and comorbidities, and needed more invasive medical devices and pronation. The occurrence of PU/PI was also associated with prolonged hospitalization and mortality.

A self-healing hydrogel and injectable cryogel of gelatin methacryloyl-polyurethane double network for 3D printing.

Three-dimensional (3D) printing of soft biomaterials facilitates the progress of personalized medicine. The development for different forms of 3D-printable biomaterials can promotes the potential manufacturing for artificial organs and provides biomaterials with the required properties. In this study, gelatin methacryloyl (GelMA) and dialdehyde-functionalized polyurethane (DFPU) were combined to create a double crosslinking system and develop 3D-printable GelMA-PU biodegradable hydrogel and cryogel. The GelMA-PU system demonstrates a combination of self-healing ability and 3D printability and provides two distinct forms of 3D-printable biomaterials with smart functions, high printing resolution, and biocompatibility. The hydrogel was printed into individual modules through an 80µm or larger nozzle and further assembled into complex structures through adhesive and self-healing abilities, which could be stabilized by secondary photocrosslinking. The 3D-printed hydrogel was adhesive, light transmittable, and could embed a light emitting diode (LED). Furthermore, the hydrogel laden with human mesenchymal stem cells (hMSCs) was successfully printed and showed cell proliferation. Meanwhile, 3D-printed cryogel was achieved by printing on a subzero temperature platform through a 210µm nozzle. After secondary photocrosslinking and drying, the cryogel was deliverable through a 16-gage (1194µm) syringe needle and can promote the proliferation of hMSCs. The GelMA-PU system extends the ink pool for 3D printing of biomaterials and has potential applications in tissue engineering scaffolds, minimally invasive surgery devices, and electronic wound dressings. STATEMENT OF SIGNIFICANCE: The 3D-printable biomaterials developed in this work are GelMA-based ink with smart funcitons and have potentials for various customized medical applications. The synthesized GelMA-polyurethane double network hydrogel can be 3D-printed into individual modules (e.g., 11×11×5mm3) through an 80μm or larger size nozzle, which are then assembled into a taller structure over five times of the initial height by self-healing and secondary photocrosslinking. The hydrogel is adhesive, light transmittable, and biocompatible that can either carry human mesenchymal stem cells (hMSCs) as bioink or embed a red light LED (620nm) with potential applications in electronic skin dressing. Meanwhile, the 3D-printed highly compressible cryogel (e.g., 6×6×1mm3) is deliverable by a 16-gage (1194μm) syringe needle and supports the proliferation of hMSCs also.

Monitoring Macro- and Microcirculation in the Critically Ill: A Narrative Review.

Circulatory shock is a common and important diagnosis in the critical care environment. Hemodynamic monitoring is quintessential in the management of shock. The currently used hemodynamic monitoring devices not only measure cardiac output but also provide data related to the prediction of fluid responsiveness, extravascular lung water, and also pulmonary vascular permeability. Additionally, these devices are minimally invasive and associated with fewer complications. The area of hemodynamic monitoring is progressively evolving with a trend toward the use of minimally invasive devices in this area. The critical care physician should be well-versed with current hemodynamic monitoring limitations and stay updated with the upcoming advances in this field so that optimal therapy can be delivered to patients in circulatory shock.

Structure and properties of fibrin/polyvinyl alcohol interpenetrating polymer network hydrogel as a modifying coating for small-diameter vascular grafts

Background: Interpenetrating polymer network (IPN) hybrid hydrogels enable regulating their properties by varying the composition and concentration of their components. Fibrin is an available natural polymer with ideal biological properties but low strength and tendency to retraction. Polyvinyl alcohol hydrogels are stable, comparable in strength to biological tissues but bioinert. Fibrin/polyvinyl alcohol (F/PVA) IPN can overcome the shortcomings of each component and create an improved material for tissue engineering.Objective: To assess the possibility of and conditions for obtaining a homogeneous IPN by subsequent fibrin polymerization and polyvinyl alcohol cryostructuring while preserving as much as possible mechanical and biological properties beneficial for tissue engineering.Methods: F/PVA IPN was obtained by subsequent fibrin polymerization (30 mg/mL) and polyvinyl alcohol cryostructuring (15, 30, and 60 mg/mL). We studied the structure using a scanning electron microscope, histology, infrared spectroscopy, and X-ray diffraction analysis. We tested mechanical properties and shrinkage of the samples. Biological features were assessed in vitro in terms of viability, cell count, proliferative and metabolic activity of EA.hy926 endothelial cell culture.Results: Our study found the maximum amount of fibrin on the surface of F30PVA15 IPN and its minimum amount on the surface of F30PVA60. These results were supported by the high biological appeal of F30PVA15 compared with F30PVA30 and F30PVA60. F30PVA60 hydrogels demonstrated shrinkage resistance compared to the template; F30PVA30 and F30PVA15 samples decreased by 1.4 and 2.5 times, respectively. Although the mechanical strength of all monocomponent hydrogels and IPN samples did not compare to that of the internal thoracic vein, F30PVA30 and F30PVA60 demonstrated better results than F30PVA15 and fibrin alone.Conclusion: Our method allows obtaining shrink-resistant IPN hydrogels with improved mechanical and tolerable biological properties at polyvinyl alcohol concentrations of &gt; 15 mg/mL and &lt; 60 mg/mL. However, the insufficient strength of this material limits its use in vascular engineering to a modifying coating. Received 25 January 2023. Revised 17 March 2023. Accepted 29 March 2023. Funding: This research was funded by the complex program of basic research under the Siberian Branch of the Russian Academy of Sciences within the basic research topic of Research Institute for Complex Issues of Cardiovascular Diseases No. 0419-2022-0001 “Molecular, cellular and biomechanical mechanisms of the pathogenesis of cardiovascular diseases in the development of new treatment methods based on personalized pharmacotherapy, minimally invasive medical devices, biomaterials and tissue-engineered implants”. Conflict of interest: The authors declare no conflict of interest. Contribution of the authorsConception and study design: V.G. Matveeva, M.A. RezvovaData collection and analysis: V.G. Matveeva, M.A. Rezvova, T.V. Glushkova, E.O. Krivkina, A.V. SergeevaStatistical analysis: V.G. Matveeva, M.A. Rezvova, T.V. Glushkova, A.V. SergeevaDrafting the article: V.G. MatveevaCritical revision of the article: V.G. Matveeva, M.A. Rezvova, L.V. Antonova, L.S. BarbarashFinal approval of the version to be published: V.G. Matveeva, M.A. Rezvova, T.V. Glushkova, A.V. Sergeeva, E.O. Krivkina, L.V. Antonova, L.S. Barbarash

Anxiety levels of ICU patients at tertiary referral hospital using Visual Analog Scale for Anxiety (VAS-A)

Patients undergoing treatment in the Intensive Care Unit (ICU) are at risk of experiencing anxiety. If left untreated, anxiety can worsen the patient's condition to the point of prolonging the length of stay in the ICU. To determine the level of anxiety of patients treated in ICU RSUD Dr. Soetomo Surabaya. This research is a descriptive study with a cross-sectional design. The research was conducted at the Rumah Sakit Umum Daerah (RSUD) Dr. Soetomo Surabaya with a data collection period of September - October 2022. The total sample obtained was 45 research subjects. The anxiety level of the study subjects was assessed using the Visual Analog Scale for Anxiety (VAS-A). Author can select Normal style from styles of this template. The results of this study were that all research subjects or as many as 100% of research subjects experienced anxiety. Overall, the research subjects experienced severe anxiety as much as 48.9%, moderate anxiety as much as 37.8%, while mild anxiety as much as 13.3%. The level of anxiety is higher in non-geriatric age (55.9%), female sex (50%), surgical patients (55.6%), research subjects with ventilator (57.1%), and research subjects with the use of invasive devices (53.6%). Most of the research subjects experienced severe anxiety. Analytical tests between anxiety trigger factors and anxiety levels were not carried out.

Reliable Visualization of the Treatment Effect of Transperineal Focal Laser Ablation in Prostate Cancer Patients by Magnetic Resonance Imaging and Contrast-enhanced Ultrasound Imaging

BackgroundTransperineal focal laser ablation (TPLA) treatment for prostate cancer (PCa) is an experimental focal ablative therapy modality with low morbidity. However, a dosimetry model for TPLA is lacking. ObjectiveTo determine (1) the three-dimensional (3D) histologically defined ablation zone of single- and multifiber TPLA treatment for PCa correlated with magnetic resonance imaging (MRI) and contrast-enhanced ultrasound (CEUS) and (2) a reliable imaging modality of ablation zone volumetry. Design, setting, and participantsThis was a prospective, multicenter, and interventional phase I/II pilot study with an ablate-and-resect design. TPLA was performed in 12 patients with localized prostate cancer divided over four treatment regimens to evaluate potential variation in outcomes. InterventionTPLA was performed approximately 4 wk prior to robot-assisted radical prostatectomy (RARP) in a daycare setting using local anesthesia. Outcome measurements and statistical analysisFour weeks after TPLA, ablation zone volumetry was determined on prostate MRI and CEUS by delineation and segmentation into 3D models and correlated with whole-mount RARP histology using the Pearson correlation index. Results and limitationsTwelve office-based TPLA procedures were performed successfully under continuous transrectal ultrasound guidance using local perineal anesthesia. No serious adverse events occurred. A qualitative analysis showed a clear demarcation of the ablation zone on T2-weighted MRI, dynamic contrast-enhanced MRI, and CEUS. On pathological evaluation, no remnant cancer was observed within the ablation zone. Ablation zone volumetry on CEUS and T2-weighted MRI compared with histology had a Pearson correlation index of r = 0.94 (95% confidence interval [CI] 0.74–0.99, p < 0.001) and r = 0.93 (95% CI 0.73–0.98, p < 0.001), respectively. ConclusionsCEUS and prostate MRI could reliably visualize TPLA ablative effects after minimally invasive PCa treatment with a high concordance with histopathological findings and showed no remnant cancer. Patient summaryThe treatment effects of a novel minimally invasive ablation therapy device can reliably be visualized with radiological examinations. These results will improve planning and performance of future procedures.

Sonolucent cranioplasty: Is therapeutic FUS the next frontier?

Focused ultrasound (FUS) has emerged as a promising area of research in neuro-oncology. Preclinical and clinical investigation has demonstrated the utility of FUS in therapeutic applications including blood brain barrier disruption for therapeutic delivery, and high intensity FUS for tumor ablation. However, FUS as it exists today is relatively invasive as implantable devices are necessary to achieve adequate intracranial penetration. Sonolucent implants, composed of materials permeable to acoustic waves, have been used for cranioplasty and intracranial imaging with ultrasound. Given the overlap in ultrasound parameters with those used for intracranial imaging, and the demonstrated efficacy of sonolucent cranial implants, we believe that therapeutic FUS through sonolucent implants represents a promising avenue of future research. The potential applications of FUS and sonolucent cranial implants may confer the demonstrated therapeutic benefits of existing FUS applications, without the drawbacks and complications of invasive implantable devices. Here we briefly summarize existing evidence regarding sonolucent implants and describe applications for therapeutic FUS.

How often are infusion sets for central venous catheters changed in Australian and New Zealand Intensive Care Units? A point prevalence survey

BackgroundInfusion sets (comprising the tubing, measuring burettes, fluid containers, transducers) that are connected to invasive vascular devices are changed on a regular basis in an effort to reduce bacterial colonisation and bloodstream infection. There is a balance between reducing infection and creating unnecessary waste. Current evidence suggests that for central venous catheters (CVCs), changing infusion sets at 7 days does not increase infection risks. ObjectivesThe objective of this study was to describe the current unit guidelines in Australian and New Zealand intensive care units (ICUs) for changing infusion sets for CVCs. Methodsprospective cross-sectional point prevalence study, as a part of the 2021 Australian and New Zealand Intensive Care Society Point Prevalence Program. ParticipantsAustralia and New Zealand (ANZ) adult ICUs and their patients on the day of the study. ResultsData were collected from 51 ICUs across ANZ. One-third of these (16/49) ICUs had a guideline that specified a 7-day replacement period, with the rest having a more frequent replacement period. ConclusionMost ICUs participating in this survey had policies to change their CVC infusion tubing in 3–4 days, and recent high-level evidence supports an update to extend this to 7 days. There remains work to be done to spread this evidence to ANZ ICUs and improve environmental sustainability initiatives.

Two-year outcomes of temperature-controlled radiofrequency device treatment of the nasal valve for patients with nasal airway obstruction.

The objective of this study was to evaluate long-term symptom improvements in patients with nasal airway obstruction (NAO) secondary to nasal valve collapse (NVC) following minimally invasive temperature-controlled radiofrequency (TCRF) treatment. A prospective, single-arm, multicenter study in patients >18 years with NAO due to NVC. Inclusion criteria were response to nasal valve dilation (e.g., modified Cottle maneuver) and baseline Nasal Obstruction Symptom Evaluation (NOSE) Scale score ≥60. Patients were treated in the nasal valve region with a TCRF device and followed through 2 years. A responder was ≥20% reduction NOSE Scale score or ≥1 reduction in severity class. A total of 122 patients were treated and 91 reached 2 years. The mean baseline NOSE Scale score was 80.3 (95% CI, 78.1-82.6). The adjusted mean change in score at 2 years was -45.8 (95% CI, -53.5 to -38.1), p < 0.001; a 57.0% improvement. The 2-year responder rate was 90.1% (95% CI, 82.3%-94.7%). Significant and sustained symptom improvement was achieved in subpopulations based on sex, age, body mass index, baseline NAO severity, nasal surgery history, NVC mechanism, septal deviation, and other anatomic contributors of NAO. No serious adverse events with a relationship to the study device and/or procedure were reported. Minimally invasive TCRF device treatment of the internal nasal valve for NAO is well tolerated and leads to significant and sustained improvement in NAO symptom severity through 2 years, including in patients with both static and dynamic NVC, septal deviation, turbinate enlargement, or prior nasal surgery. 2b.

Electrophysiological and Histological Correlations of Optic Neuritis in the Dark Agouti Rat Model of Experimental Autoimmune Encephalomyelitis

Experimental autoimmune encephalomyelitis (EAE) is an animal model of Inflammatory central nervous system (CNS) disease. Dark agouti (DA) rats immunized with full-length myelin oligodendrocyte glycoprotein (MOG1-125) typically develop a relapsing-remitting EAE form characterized by predominant demyelinating involvement of the spinal cord and optic nerve. Visually evoked potentials (VEP) are a useful objective tool to assess the optic nerve function and monitor electrophysiological changes in optic neuritis (ON). The current study aimed to assess the VEP changes in MOG-EAE DA rats using a minimally invasive recording device and to correlate them with histological findings. Twelve MOG-EAE DA rats and four controls underwent VEP recording at day 0, 7, 14, 21, and 28 post-EAE induction. Tissue samples were obtained on days 14, 21, and 28 from two EAE rats and one control. The median VEP latencies were significantly higher on days 14, 21, and 28 compared to baseline, with maximal latencies observed on day 21. The histological analyses on day 14 demonstrated inflammation with largely preserved myelin and axonal structures. Inflammation and demyelination with largely preserved axons were evident on days 21 and 28, which correlated with prolonged VEP latencies. These findings suggest that VEPs may be a reliable biomarker reflecting the optic nerve involvement in EAE. Moreover, the use of a minimally invasive device enables observation of VEP changes over time in MOG-EAE DA rats. Our findings may have important implications for testing the potential neuroprotective and regenerative effects of new therapies for CNS demyelinating diseases.

Improving difficult peripheral intravenous access requires thought, training and technology (DART3): a stepped-wedge, cluster randomised controlled trial protocol

BackgroundPeripheral intravenous catheters (PIVCs) are the most used invasive medical device in healthcare. Yet around half of insertion attempts are unsuccessful leading to delayed medical treatments and patient discomfort of harm. Ultrasound-guided PIVC (USGPIVC) insertion is an evidence-based intervention shown to improve insertion success especially in patients with Difficult IntraVenous Access (BMC Health Serv Res 22:220, 2022), however the implementation in some healthcare settings remains suboptimal. This study aims to co-design interventions that optimise ultrasound guided PIVC insertion in patients with DIVA, implement and evaluate these initiatives and develop scale up activities.MethodsA stepped-wedge cluster randomized controlled trial will be conducted in three hospitals (two adult, one paediatric) in Queensland, Australia. The intervention will be rolled out across 12 distinct clusters (four per hospital). Intervention development will be guided by Michie’s Behavior Change Wheel with the aim to increase local staff capability, opportunity, and motivation for appropriate, sustainable adoption of USGPIVC insertion. Eligible clusters include all wards or departments where > 10 PIVCs/week are typically inserted. All clusters will commence in the control (baseline) phase, then, one cluster per hospital will step up every two months, as feasible, to the implementation phase, where the intervention will be rolled out. Implementation strategies are tailored for each hospital by local investigators and advisory groups, through context assessments, staff surveys, and stakeholder interviews and informed by extensive consumer interviews and consultation. Outcome measures align with the RE-AIM framework including clinical-effectiveness outcomes (e.g., first-time PIVC insertion success for DIVA patients [primary outcome], number of insertion attempts); implementation outcomes (e.g., intervention fidelity, readiness assessment) and cost effectiveness outcomes. The Consolidated Framework for Implementation Research framework will be used to report the intervention as it was implemented; how people participated in and responded to the intervention; contextual influences and how the theory underpinning the intervention was realised and delivered at each site. A sustainability assessment will be undertaken at three- and six-months post intervention.DiscussionStudy findings will help define systematic solutions to implement DIVA identification and escalation tools aiming to address consumer dissatisfaction with current PIVC insertion practices. Such actionable knowledge is critical for implementation of scale-up activities.Trial registrationProspectively registered (Australian and New Zealand Clinical Trials Registry; ACTRN12621001497897).

Resource interdependence and successful exit: A configurational perspective on young technology firms

AbstractResearch SummarySuccessful exits are important outcomes for young technology firms. Research has investigated how individual resources affect exit, but both foundational RBV scholarship and newer microfoundations work suggest the need to examine resource configurations in specific contexts. Using an abductive approach and fsQCA methodology, we explore how resource configurations affect exit in the U.S. minimally invasive medical device industry. We find no single resource is necessary or sufficient for exit. Instead, we find four unique equifinal configurations of resources that are sufficient to support exit in certain contexts. Further, these configurations are largely replicated when we distinguish specific exit modes (IPO vs. acquisition). This study advances growing conversations on the role of resource configurations in entrepreneurship with an emphasis on interdependence, complexity, and equifinality of exit.Managerial SummaryNew firms' early resource portfolios are powerful determinants of their future success. No theory exists, however, to predict if or how the combinations of these resources affect young technology ventures' abilities to achieve a successful exit—an outcome important to founders and early investors. In this study, we utilize fsQCA to explore this issue on a sample of startups in a segment of the U.S. medical device industry. We focus on configurations of technological, commercial, social, human, and financial capital as well as the external environment. Our results point to four unique paths that support successful exit. Each configuration includes multiple ingredients for success. This suggests that realizing successful exit is more complex than previously thought as several unique resource configurations support successful exit.

Nurses’ education, knowledge and perceptions of peripheral intravenous catheter management: A web-based, cross-sectional survey

BackgroundPeripheral intravenous catheters (PIVCs) are the most used invasive medical device. Unfortunately, PIVCs fail for a variety of reasons and failure often results in serious adverse events leading to patient discomfort, infection, delays in treatment, increased healthcare costs, and even death. In Australia, qualified nurses assess, manage, and remove a PIVC as part of their clinical role. To date, no study has described the current state of knowledge and confidence (self-efficacy) about PIVCs from the perspectives of qualified nurses working in Australian hospital settings.AimsTo describe the current state of knowledge and confidence (self-efficacy) about PIVC management from the perspectives of qualified nurses working in Australian hospital settings. To explore how these related to the education received by these nurses.MethodsAn online cross-sectional survey.FindingsQualified nurses in Australia thought that education about PIVCs was important and that it should be underpinned by evidence-based guidelines. Knowledge Test score for the sample was 12.4/17 (SD 2.1), this equates to a mean grade of 73.0%. Respondents reported very high levels of confidence about caring for a patient with a PIVC in situ.ConclusionDespite the frequent and increasing use of PIVCs and importantly the documented adverse events associated with poor assessment, management and inappropriate removal, qualified nurses’ knowledge and confidence remain poorly reported. We demonstrated fundamental gaps in qualified nurses’ knowledge in relation to assessment, management, and removal of PIVCs.

Fluorescent-based biodegradable microneedle sensor array for tether-free continuous glucose monitoring with smartphone application.

Continuous glucose monitoring (CGM) allows patients with diabetes to manage critical disease effectively and autonomously and prevent exacerbation. A painless, wireless, compact, and minimally invasive device that can provide CGM is essential for monitoring the health conditions of freely moving patients with diabetes. Here, we propose a glucose-responsive fluorescence-based highly sensitive biodegradable microneedle CGM system. These ultrathin and ultralight microneedle sensor arrays continuously and precisely monitored glucose concentration in the interstitial fluid with minimally invasive, pain-free, wound-free, and skin inflammation-free outcomes at various locations and thicknesses of the skin. Bioresorbability in the body without a need for device removal after use was a key characteristic of the microneedle glucose sensor. We demonstrated the potential long-term use of the bioresorbable device by applying the tether-free CGM system, thus confirming the successful detection of glucose levels based on changes in fluorescence intensity. In addition, this microneedle glucose sensor with a user-friendly designed home diagnosis system using mobile applications and portable accessories offers an advance in CGM and its applicability to other bioresorbable, wearable, and implantable monitoring device technology.

PEDS12: Use of Impella 5.5 in the Pediatric Population – Safety and Outcomes

Background: Transvalvular micro-axial flow pumps for mechanical circulatory support have continued to advance, with the latest devices providing up to 5.5L/min of flow. These devices have been successfully utilized in the adult population, however safety and efficacy data in the pediatric patient is limited. Here, we present our institutional experience with Impella 5.5 placement in pediatric patients. Methods: Five pediatric patients underwent right axillary artery graft placement and attempted placement of the Impella 5.5 device between August 2020 and January 2023 at our institution. Most patients received pre-operative imaging to evaluate axillary artery anatomy, and all undergo post-operative monitoring for hemolysis and device positioning. Results: Five pediatric patients received Impella 5.5 placement: three male and two female patients, ages 13.2, 13.7, 13.8, 16.8, and 16.9 years (Table). Indications for device implantation were heart failure secondary to myocarditis (2), allograft rejection of prior orthotopic heart transplant, idiopathic dilated cardiomyopathy, and heart failure after transposition of the great arteries repair. Impella 5.5 placement was unsuccessful in a 13.8-year-old female patient due to prohibitively acute right subclavian anatomy, and VA-ECMO cannulation was performed instead via the axillary graft. In the four patients with successful Impella 5.5 placements, median duration of support was 13.5 days (range 7-42 days). One patient experienced cardiac arrest secondary to coagulation-associated device failure, requiring temporary left ventricular assist device implantation (Figure). Three patients were bridged to transplant, two of whom received transplant directly from Impella 5.5, while one received transplant after HeartMate III. The final patient had a HeartMate III placed on Impella day 42 and is currently awaiting transplant. Conclusion: The Impella 5.5 is a minimally invasive mechanical circulatory support device which can be used to bridge pediatric patients to cardiac transplantation. Although exact size cutoff and anatomy are still being determined, our experience gives a framework for which smaller patients are still appropriate for device placement. Careful patient selection and post-placement monitoring are required to achieve optimal outcomes as a bridge to recovery, durable device, or transplant.Figure 1. Operative image demonstrating clot at Impella 5.5 outflow tract associated with cardiac arrest and device failure.