Development of a Modular Tissue Phantom for Evaluating Vascular Access Devices.
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ABSTRACT:
SUBMITTER: Boice EN
PROVIDER: S-EPMC9311941 | biostudies-literature | 2022 Jul
REPOSITORIES: biostudies-literature
Publications
Development of a Modular Tissue Phantom for Evaluating Vascular Access Devices.
Boice Emily N EN Berard David D Gonzalez Jose M JM Hernandez Torres Sofia I SI Knowlton Zechariah J ZJ Avital Guy G Snider Eric J EJ
Bioengineering (Basel, Switzerland) 20220715 7
Central vascular access (CVA) may be critical for trauma care and stabilizing the casualty. However, it requires skilled personnel, often unavailable during remote medical situations and combat casualty care scenarios. Automated CVA medical devices have the potential to make life-saving therapeutics available in these resource-limited scenarios, but they must be properly designed. Unfortunately, currently available tissue phantoms are inadequate for this use, resulting in delayed product develop ...[more]
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Project description:BackgroundRandomized controlled trials evaluate the effectiveness of interventions for central venous access devices, however, high complication rates remain. Scoping reviews map the available evidence and demonstrate evidence deficiencies to focus ongoing research priorities.MethodA scoping review (January 2006-December 2015) of randomized controlled trials evaluating the effectiveness of interventions to improve central venous access device outcomes; including peripherally inserted central catheters, non-tunneled, tunneled and totally implanted venous access catheters. MeSH terms were used to undertake a systematic search with data extracted by two independent researchers, using a standardized data extraction form.ResultsIn total, 178 trials were included (78 non-tunneled [44%]; 40 peripherally inserted central catheters [22%]; 20 totally implanted [11%]; 12 tunneled [6%]; 6 non-specified [3%]; and 22 combined device trials [12%]). There were 119 trials (68%) involving adult participants only, with 18 (9%) pediatric and 20 (11%) neonatal trials. Insertion-related themes existed in 38% of trials (67 RCTs), 35 RCTs (20%) related to post-insertion patency, with fewer trials on infection prevention (15 RCTs, 8%), education (14RCTs, 8%), and dressing and securement (12 RCTs, 7%). There were 46 different study outcomes reported, with the most common being infection outcomes (161 outcomes; 37%), with divergent definitions used for catheter-related bloodstream and other infections.ConclusionMore high quality randomized trials across central venous access device management are necessary, especially in dressing and securement and patency. These can be encouraged by having more studies with multidisciplinary team involvement and consumer engagement. Additionally, there were extensive gaps within population sub-groups, particularly in tunneled devices, and in pediatrics and neonates. Finally, outcome definitions need to be unified for results to be meaningful and comparable across studies.
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Project description:Access to the central vasculature is critical for hemodynamic monitoring and for delivery of life-saving therapeutics during emergency medicine and battlefield trauma situations but requires skill often unavailable in austere environments. Automated central vascular access devices (ACVADs) using ultrasound and robotics are being developed. Here, we present an ex vivo lower-body porcine model as a testing platform for evaluation of vascular devices and compare its features to commercially available platforms. While the commercially available trainers were simpler to set-up and use, the scope of their utility was limited as they were unable to provide realistic anatomic, physiologic, and sonographic properties that were provided by the ex vivo model. However, the ex vivo model was more cumbersome to set-up and use. Overall, both have a place in the development and evaluation pipeline for ACVADs before testing on live animals, thus accelerating product development and translation.
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Project description:PurposeTo evaluate the technical success and complication rates of vascular closure devices (VCDs) in the axillary artery.Materials and methodsMEDLINE and Embase were searched independently by two reviewers to identify observational studies from inception through October 2021. The following outcomes were meta-analyzed: technical success, hematoma, dissection, pseudoaneurysm, infection, and local neurological complications. Complications were also graded as mild, moderate, and severe. A logistic regression evaluating the influence of sheath size for the outcome of technical success rate was performed using individual patient-level data.ResultsOf 1496 unique records, 20 observational studies were included, totaling 915 unique arterial access sites. Pooled estimates were as follows: technical success 84.8% (95% confidence interval [CI]: 78%-89.7%, I2=60.4%), hematoma 7.9% (95% CI: 5.8%-10.6%, I2=0%), dissection 3.1% (95% CI: 1.3%-7.3%, I2=0%), pseudoaneurysm 2.7% (95% CI: 1.3%-5.7%, I2=0%), infection <1% (95% CI: 0%-5.7%, I2=20.5%), and local neurological complications 2.7% (95% CI: 1.7%-4.4%, I2=0%). There was a significant negative association between sheath size and technical success rate (odds ratio [OR]: 0.87 per 1 French (Fr) increase in sheath size, 95% CI: 0.80-0.94, p=0.0005). Larger sheath sizes were associated with a greater number of access-site complications (adjusted odds ratio [aOR]: 1.21 per 1 Fr increase sheath size, 95% CI: 1.04-1.40, p=0.013).ConclusionsOff-label use of VCDs in the axillary artery provides an 85% successful closure rate and variable complication rate, depending on the primary procedure and sheath size. Larger sheaths were associated with a lower technical success and greater rate of access-related complications.Clinical impactSafe arterial access is the foundation for arterial intervention. While the common femoral artery is a well established access site, alternative arterial access sites capable of larger sheath sizes are needed in the modern endovascular era. This article provides the largest synthesis to date on the use of vascular closure devices for percutaneous axillary artery access in endovascular intervention. It should serve clinicians with added confidence around this approach in terms of providing a reference for technical success and complications. Clinically, this data is relevant for patient consent purposes as well as for practice quality improvement in setting safety standards for this access site.
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Project description:ObjectiveTo assess the nurses' knowledge of vascular access devices for patients undergoing hemodialysis programs in the Gaza Strip, Palestine.MethodsA descriptive cross-sectional study was conducted to assess the nurses' knowledge of hemodialysis vascular access using the convenience sampling technique. The assessment tool comprised 60 items related to the nurses' knowledge and 7 items on demographic characteristics at hemodialysis units in 5 governmental hospitals in the Gaza Strip, between March and June 2023. Statistical analysis of the collected data was performed using SPSS version 22.ResultsA total of 65 nurses in hemodialysis units were included. Of the majority of study nurses 71% were male, 21.5% of nurses had fair knowledge, and 78.5% had good knowledge about vascular access devices. The overall average score was more than 70% in all dimensions, which revealed good knowledge about vascular access devices. The study indicated that there was a statistically significant association between nurses' knowledge of vascular access devices and (years of experience in the hemodialysis unit, and received training of nurses).ConclusionsThe knowledge of hemodialysis nurses toward vascular access devices for patients undergoing hemodialysis was good. The years in the hemodialysis unit and having training have shown significant association with knowledge among hemodialysis nurses on vascular access devices care. Thus, interventions should focus on providing training for nurses about vascular access devices care in hemodialysis units to improve the comprehensive knowledge of nurses and to maintain patient's health status.
| S-EPMC11526276 | biostudies-literature
Project description:Neonates often require vascular access devices for medication or fluid therapy, but a third of devices fail before treatment completion or end with a complication. For adults and children, securing these devices with tissue adhesive (TA) increases the dwell and reduces complications. However, there is a lack of evidence for the neonatal population. This scoping review aimed to assess the evidence of TA for vascular access devices in neonates. The Arksey and O'Malley's (2005) framework was used. The inclusion criteria covered studies published from 2007 (when TA was first reported for use in vascular access devices) to June 2024, available in English, Portuguese, and Spanish, across six databases. Two independent reviewers assessed the studies using Covidence software, with a third reviewer resolving conflicts. Quality assessment was performed using the Mixed Methods Appraisal Tool. From 981 identified studies, 12 were included. Most studies (n = 5, 41.7%) enrolled between 100 and 500 neonates with vascular access devices. Publications originated from four regions and were observational studies (n = 6, 50%), quasi-experimental (n = 3, 25%), and case series (n = 2, 16.7%) with one randomized controlled trial (8.3%) focusing on umbilical venous catheters (UVC). The most common TA composition used was a combination of n-butyl- and 2-octyl- cyanoacrylate (n = 4, 33.3%). The amount of TA applied varied across studies, and often TA was part of a bundle (n = 7, 58.3%). Most studies applied TA to central venous access devices (n = 10, 83.3%) and 2 (16.7%) in peripheral devices. Although there was variation in device failure, the studies generally indicated a reduction in complications such as dislodgment (central catheter: 11.3% [peripherally inserted central catheter {PICC}] to 24.6% [UVC] in non-TA group vs 0.7% [PICC] to 7.7% [UVC] in TA group), device-associated bloodstream infections (central: 7.7% [UVC] and incidence of 2.76/1000 catheter days [PICC] in non-TA group vs 3.1% [UVC] and incidence of 0.99/1000 catheter day [PICC] in TA group), and phlebitis (13% in non-TA group vs 3% in TA-group), as well as increased dwell time in peripheral catheters. Most studies included both term and preterm neonates but did not differentiate between them in their analyses. Skin assessment, life of first dressing, and follow-up of catheters and patients were not reported in most studies.ConclusionTA may reduce complications in vascular access devices, but the evidence in neonates is limited and varied. Many studies include TA as part of bundle, making it difficult to isolate its effects. Additionally, the current evidence lacks robustness due to the design limitations of the studies. Future research should focus on randomized controlled trials to evaluate TA's effectiveness and safety in preventing device failures and complications in neonates, considering different subgroups, to ensure the safety of TA in these nuanced populations.What is known• Research in adults and pediatrics provides evidence supporting the use of tissue adhesive (TA) for vascular access devices, showing a positive impact in reducing failures and complications. • The use of TA in neonates needs to be carefully considered due to their unique characteristics.What is new• There is a gap in the literature on the use of TA for securing vascular access devices in neonates, particularly regarding its safety and effectiveness in preventing failures and complications. • Further studies are needed to provide robust evidence verifying the effectiveness and safety of TA in this population.
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Project description:Physical phantoms have been widely used for performance evaluation of magnetic resonance imaging (MRI). Although there are many kinds of physical phantoms, most MRI phantoms use fixed configurations with specific sizes that may fit one or a few different types of radio frequency (RF) coils. Therefore, it has limitations for various image quality assessments of scanning areas. In this article, we report a novel design for a truly customizable MRI phantom called the LEGO-compatible Modular Mapping (MOMA) phantom, which not only serves as a general quality assurance phantom for a wide range of RF coils, but also a flexible calibration phantom for quantitative imaging. The MOMA phantom has a modular architecture which includes individual assessment functionality of the modules and LEGO-type assembly compatibility. We demonstrated the feasibility of the MOMA phantom for quantitative evaluation of image quality using customized module assembly compatible with head, breast, spine, knee, and body coil features. This unique approach allows comprehensive image quality evaluation with wide versatility. In addition, we provide detailed MOMA phantom development and imaging characteristics of the modules.
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Project description:BackgroundThough 60-80% of hospitalized patients have an intravascular device placed during hospitalization, there is a substantial risk of complication related to the placement, maintenance and removal of these devices. The objectives of this study were to describe vascular access device use, device complications and lumen dysfunction.MethodsAn observational cohort study was conducted over a 4.5 years period, in two quaternary, university-affiliated paediatric intensive care units (ICU). Eligible patients were admitted to either the paediatric or cardiac ICU and had one or more vascular access devices in-situ at the time of enrolment. Vascular access devices were defined as any external connection directly into the circulation including peripheral and central veins, arteries or bone marrow. Consistent with practice in the studied ICUs removal of peripheral catheters was regarded as due to dysfunction or complication.Results220 patients, 683 devices and 924 lumens were observed. The device complication rate was 21% and the lumen complication rate was 25%. The median duration without complication was 18 days for arterial catheters, 14 days for central venous catheters; 13 days for peripherally inserted central catheters and 4 days for peripheral intravenous catheters. On one third of all patient days, the volume of fluid administered to maintain VADs was equal to or greater than 20% of the total hourly total fluid intake.ConclusionApproximately 1 in 5 vascular devices had one or more complications in ICU, most devices continued to be used without removal, and some complications resolved. The implications of the fluids infused to maintain device function warrants further study, as do strategies to resolve or limit the their complications in children.
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Project description:BackgroundInitiating hemodialysis via an arteriovenous (AV) access is considered best practice for most patients. Despite the well-recognized advantages of AV access, 80% of US patients start hemodialysis with a catheter. Limited patient knowledge about vascular access, among other factors, may play a role in this high rate. We used iterative stakeholder input to develop novel, mixed media vascular access education materials and evaluated their preliminary acceptability.MethodsWe conducted preliminary focus groups and interviews with key stakeholders to assess patient vascular access understanding and elicit perspectives on existing education materials. We then used stakeholder input to inform initial development and iterative updates to the content and design of an animated video and complementary brochure. Video development (scripting, storyboarding, animation) was guided by an evidence-based framework and two health behavior change models. We assessed acceptability of the completed materials with patients and medical providers/personnel via interviews.ResultsOverall, 105 stakeholders participated in education materials development and review (80 patients/care partners, 25 medical providers/personnel). Preliminary qualitative work included 52 patients/care partners and 16 providers/personnel; video development included 28 patients/care partners and nine providers/personnel. The video script, storyboards, and animation underwent 14, four, and nine stakeholder-guided iterations, respectively. Responsive changes included aesthetic modifications, technical updates, and content additions (e.g., HD circuit, access self-monitoring, enhanced patient testimonials). The final 18-minute video and complementary brochure define vascular access types, describe care processes, outline potential complications, and address common patient concerns. Interviews with 28 patients/care partners and nine providers/personnel from diverse geographic regions revealed preliminary acceptability of, and enthusiasm for, the materials by patients and providers.ConclusionsIn collaboration with key stakeholders, we developed mixed media vascular access education materials that were well-received by patients and providers. Preliminary findings suggest that the materials are promising to improve vascular access understanding among patients.
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Project description:IntroductionThe comparative effectiveness of ProGlide® compared with MANTA® vascular closure devices (VCDs) in large-bore access site management is not entirely certain, and has only been evaluated in underpowered studies. This meta-analysis aimed to evaluate the outcomes of ProGlide® compared with MANTA® VCDs.MethodsPubMed, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched systematically for relevant articles from the inception of the database until August 27, 2021. The outcomes of interest were all bleeding events, major bleeding, major and minor vascular complications, pseudoaneurysm, stenosis or dissection, and VCD failure. Risk ratios were used as point estimates of endpoints. All statistical analyses were carried out using R version 4.0.3.ResultsFour observational studies and 1 pilot randomized controlled trial (RCT) were included in the final analysis. There was no significant difference between the ProGlide® and MANTA® groups in the risk of all bleeding events, major/life-threatening bleeding, major vascular complications, minor vascular complications, pseudoaneurysms, and/or stenosis or dissection of the entry site vessel. However, the incidence of VCD failure was higher in the ProGlide® group compared with the MANTA® group (RR 1.94; 95% CI 1.31-2.84; I2 = 0%).ConclusionIn conclusion, both VCDs (ProGlide® and MANTA®) have comparable outcomes with regard to risk of bleeding, vascular complications, pseudoaneurysms, and/or stenosis or dissection of entry vessel. ProGlide® was however associated with higher device failure.
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Project description:Microfluidic barrier tissue models have emerged as advanced in vitro tools to explore interactions with external stimuli such as drug candidates, pathogens, or toxins. However, the procedures required to establish and maintain these systems can be challenging to implement for end users, particularly those without significant in-house engineering expertise. Here we present a module-based approach that provides an easy-to-use workflow to establish, maintain, and analyze microscale tissue constructs. Our approach begins with a removable culture insert that is magnetically coupled, decoupled, and transferred between standalone, prefabricated microfluidic modules for simplified cell seeding, culture, and downstream analysis. The modular approach allows several options for perfusion including standard syringe pumps or integration with a self-contained gravity-fed module for simple cell maintenance. As proof of concept, we establish a culture of primary human microvascular endothelial cells (HMVEC) and report combined surface protein imaging and gene expression after controlled apical stimulation with the bacterial endotoxin lipopolysaccharide (LPS). We also demonstrate the feasibility of incorporating hydrated biomaterial interfaces into the microfluidic architecture by integrating an ultra-thin (< 1 μm), self-assembled hyaluronic acid/peptide amphiphile culture membrane with brain-specific Young's modulus (~ 1kPa). To highlight the importance of including biomimetic interfaces into microscale models we report multi-tiered readouts from primary rat cortical cells cultured on the self-assembled membrane and compare a panel of mRNA targets with primary brain tissue signatures. We anticipate that the modular approach and simplified operational workflows presented here will enable a wide range of research groups to incorporate microfluidic barrier tissue models into their work.
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