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BACKGROUND: Interest in and use of electronic consent (e-consent) in the conduct of academic clinical trials has increased since the COVID-19 pandemic. E-consent offers advantages including increased efficiency and accessibility, and reduced burden on site staff, which can be appealing to academic trialists anticipating challenges in recruitment to complex trial designs or with limited funding. However, there are many options to consider when using e-consent in a study protocol. This paper presents five case studies from Norwich Clinical Trials Unit, demonstrating how e-consent models can be effectively tailored to the needs of different trials. These examples illustrate the options around and benefits of e-consent, the acceptability of e-consent by participants, and the design considerations that were made during the development of the trial protocols. CASE STUDIES: Five randomised trials are presented, selected from a range of different trial designs, disease areas, interventions, and patient populations. E-consent was either offered as an alternative to paper consent, according to participant preference, or as the sole method of consent. E-consent was generally used to facilitate remote consent in decentralised trials but was also chosen to increase efficiency and reduce burden in an emergency department setting. The technical implementation of e-consent and detailed participant procedures were tailored to the needs of the trial settings and patient populations. For example, accompanying participant information sheets were provided in paper or electronic form, and electronic signatures could be typed or drawn. Administrative data on uptake of e-consent is presented where available. CONCLUSION: This paper demonstrates that the operational and technical aspects of implementing e-consent in clinical trials can be influenced by the trial design, the needs and characteristics of the trial population, financial/efficiency considerations, and level of risk. E-consent is not a one-size-fits-all tool for trials, and its use should be carefully considered during the development of the trial protocol, in conjunction with patient and public involvement contributors, site staff and other trial stakeholders.
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COVID-19 , Consentimento Livre e Esclarecido , Ensaios Clínicos Pragmáticos como Assunto , Humanos , COVID-19/epidemiologia , Ensaios Clínicos Pragmáticos como Assunto/métodos , Projetos de Pesquisa , SARS-CoV-2 , Reino Unido , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Seleção de PacientesRESUMO
Introduction: The diagnosis and management of cow's milk allergy (CMA) is a topic of debate and controversy. Our aim was to compare the opinions of expert groups from the Middle East (n = 14) and the European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) (n = 13). Methods: These Expert groups voted on statements that were developed by the ESPGHAN group and published in a recent position paper. The voting outcome was compared. Results: Overall, there was consensus amongst both groups of experts. Experts agreed that symptoms of crying, irritability and colic, as single manifestation, are not suggestive of CMA. They agreed that amino-acid based formula (AAF) should be reserved for severe cases (e.g., malnutrition and anaphylaxis) and that there is insufficient evidence to recommend a step-down approach. There was no unanimous consensus on the statement that a cow's milk based extensively hydrolysed formula (eHF) should be the first choice as a diagnostic elimination diet in mild/moderate cases. Although the statements regarding the role for hydrolysed rice formula as a diagnostic and therapeutic elimination diet were accepted, 3/27 disagreed. The votes regarding soy formula highlight the differences in opinion in the role of soy protein in CMA dietary treatment. Generally, soy-based formula is seldom available in the Middle-East region. All ESPGHAN experts agreed that there is insufficient evidence that the addition of probiotics, prebiotics and synbiotics increase the efficacy of elimination diets regarding CMA symptoms (despite other benefits such as decrease of infections and antibiotic intake), whereas 3/14 of the Middle East group thought there was sufficient evidence. Discussion: Differences in voting are related to geographical, cultural and other conditions, such as cost and availability. This emphasizes the need to develop region-specific guidelines considering social and cultural conditions, and to perform further research in this area.
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BACKGROUND: Large tissue defects following pelvic exenteration (PE) fill with fluid and small bowel, leading to the empty pelvis syndrome (EPS). EPS causes a constellation of complications including pelvic sepsis and reduced quality of life. EPS remains poorly defined and cannot be objectively measured. Pathophysiology of EPS is multifactorial, with increased pelvic dead space potentially important. This study aims to describe methodology to objectively measure volumetric changes relating to EPS. METHODS: The true pelvis is defined by the pelvic inlet and outlet. Within the true pelvis there is physiological pelvic dead space (PDS) between the peritoneal reflection and the inlet. This dead space is increased following PE and is defined as the exenteration pelvic dead space (EPD). EPD may be reduced with pelvic filling and the volume of filling is defined as the pelvic filling volume (PFV). PDS, EPD, and PFV were measured intraoperatively using a bladder syringe, and Archimedes' water displacement principle. RESULTS: A patient undergoing total infralevator PE had a PDS of 50 ml. A rectus flap rendered the pelvic outlet watertight. EPD was then measured as 540 ml. Therefore there was a 10.8-fold increase in true pelvis dead space. An omentoplasty was placed into the EPD, displacing 130 ml; therefore, PFV as a percentage of EPD was 24.1%. CONCLUSIONS: This is the first reported quantitative assessment of pathophysiological volumetric changes of pelvic dead space; these measurements may correlate to severity of EPS. PDS, EPD, and PFV should be amendable to assessment based on perioperative cross-sectional imaging, allowing for potential prediction of EPS-related outcomes.
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Exenteração Pélvica , Pelve , Humanos , Exenteração Pélvica/efeitos adversos , Exenteração Pélvica/métodos , Feminino , Complicações Pós-Operatórias/etiologia , Síndrome , Pessoa de Meia-Idade , Omento/cirurgiaRESUMO
Substance misuse is common in patients undergoing limb reconstruction secondary to open fractures and fracture related infection. This group risk breaching the social contract with their treating team through reduced engagement with perioperative care. Potential problems include limited social support, intravenous access, analgesia and withdrawal. These factors may negatively influence the range of treatments offered to this group. We aimed to establish the prevalence and outcomes of the problematically non-concordant cohort in our limb reconstruction population, who we aim to treat equitably even where non-concordance is suspected pre-operatively. A retrospective study was performed using our prospectively collected free flap limb reconstruction database from December 2021-October 2023. Patient electronic health records were reviewed for demographics, perioperative details and outcomes. Eighty patients were identified, with 8 identified as problematically non-concordant (10%). All patients had a background of substance abuse; smoking (100%), alcohol (75%), IVDU (63%). Pre-operative non-concordance included absconding (43%), staff abuse (57%) and refusal of care (57%). Post-operative non-concordance included smoking (75%), mobilisation against instructions (75%), absconding (63%). No patients had free flap failure. Inpatient stay varied from 8-83 days, average 28.50% of patients did not attend follow-up. The expanding horizon of microsurgery means complex reconstruction is offered to a greater range of patients. Surgical teams should ensure that this service is offered equitably, individualising treatment plans to achieve the best outcomes. Risk of non-concordance is usually evident pre-operatively. We advise early involvement of substance misuse teams, discharge support and an understanding team to achieve good outcomes.
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Retalhos de Tecido Biológico , Microcirurgia , Procedimentos de Cirurgia Plástica , Humanos , Masculino , Estudos Retrospectivos , Feminino , Pessoa de Meia-Idade , Microcirurgia/métodos , Adulto , Procedimentos de Cirurgia Plástica/métodos , Idoso , Transtornos Relacionados ao Uso de Substâncias , Fraturas Expostas/cirurgiaRESUMO
BACKGROUND: In this article, we apply a gender-based analysis plus framework to research the housing experiences of older, low-income adults living and aging in Hamilton. Low-income older adults with intersectional identities are at risk of not aging in place due to marginalization and housing instability. OBJECTIVE: Policy currently homogenizes the experience of aging by sidelining intersectional factors that have a bearing on aging well in place. The research aims to develop policy recommendations to address this gap. METHODS: Several methods captured the housing experiences of low-income older adults, including interviews, participant observation, and arts-based techniques. FINDINGS: Findings illustrate how gender and intersectional factors shape both housing trajectories and agentive practices low-income adults utilize to try to age well and in place. These strategies encompass practicing cultural citizenship, which is a claim for inclusion when excluded from mainstream ideals of aging in place. DISCUSSION: We provide policy recommendations informed by participants' lived experiences aimed at promoting equitable aging in place as fundamental to full citizenship.
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Background: Specific death due to DR-TB has significantly contributed to tuberculosis (TB) mortality and overall global deaths. Aim: This study examines the predictors of mortality among DR-TB patients in Kaduna State, Nigeria. Subject and Method: This was a retrospective longitudinal study of DR-TB mortality carried out among 370 DR-TB patients from the 23 LGAs in Kaduna State. It involves a retrospective review of the MDR-TB records of the patients over a period of 10 years (2012-2021). Demographic and clinical data of all DR-TB patients enrolled in Kaduna State, Nigeria, between April 1, 2012, and March 31, 2021, were used. Survival analysis was performed with SPSS version 25, using Kaplan-Meier and Cox proportional hazard regression modeling, at 5% significance level. Results: The majority of the patients, 255 (68.9%), were below the age of 40 years, while 53 (14.3%) of the patients died within the study period. Most deaths 26 (49.1%) were associated with HIV co-infection and the disease severity. Results for the Cox proportional model show that there was a significantly lower risk of death when a patient had MDR-TB compared to pre-XDR-TB (adjusted hazard ratio, AHR = 0.34, 95% CI = 0.16-0.72, P = 0.04). Both models show that age, sex, residence, or year of treatment had no significant association with survival or death. Conclusion: HIV co-infection and DRTB with progression to more resistant and difficult-to-treat strains contributed to higher deaths. There is a need for concerted efforts from all DR-TB stakeholders to control the disease.
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Coinfecção , Infecções por HIV , Tuberculose Resistente a Múltiplos Medicamentos , Tuberculose , Humanos , Adulto , Estudos Retrospectivos , Estudos Longitudinais , Nigéria/epidemiologia , Tuberculose Resistente a Múltiplos Medicamentos/tratamento farmacológico , Tuberculose Resistente a Múltiplos Medicamentos/epidemiologia , Tuberculose/epidemiologia , Infecções por HIV/tratamento farmacológico , Infecções por HIV/epidemiologiaRESUMO
Computed tomography (CT) scanning is the imaging modality of choice when planning the overall management and operative approach to complex abdominal wall hernias. Despite its availability and well-recognised benefits there are no guidelines or recommendations regarding how best to read or report such scans for this application. In this paper we aim to outline an approach to interpreting preoperative CT scans in abdominal wall reconstruction (AWR). This approach breaks up the interpretive process into 4 steps-concentrating on the hernia or hernias, any complicating features of the hernia(s), the surrounding soft tissues and the abdominopelvic cavity as a whole-and was developed as a distillation of the authors' collective experience. We describe the key features that should be looked for at each of the four steps and the rationale for their inclusion.
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Parede Abdominal , Hérnia Ventral , Hérnia Incisional , Cirurgia Plástica , Humanos , Parede Abdominal/cirurgia , Hérnia Ventral/cirurgia , Hérnia Incisional/cirurgia , Herniorrafia/métodos , Tomografia Computadorizada por Raios X/métodosRESUMO
Background: Environmental exposure to toxins has been strongly implicated in its multi-faceted etiology of chronic kidney disease, a serious public health problem affecting individuals, families, and communities. There is a need to synthesize available studies on the effect of heavy metal exposure on renal function, considering the rising global burden of kidney disease. The objective of this study is to determine the association between exposure to heavy metals and renal disease. Methods: The Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) were used to conduct the review. A comprehensive independent search, title, abstract, and full-text screening of available literature on Google Scholar, PubMed, and OAREScience was done between March 2021 and May 2021. The criteria for study inclusion were full-text articles published in English language in the last 20 years (2001-2020), and observational primary human studies reporting the association between heavy metal exposure and renal disease. The Newcastle-Ottawa Quality Assessment Scale was used to assess the quality of the included studies. Results: A total of 552 studies were identified following the search from the different databases. A total of 13 studies were finally included in the review. Heavy metals implicated in the studies include cadmium, lead, mercury, and arsenic, with ten studies showing environmental exposure as the primary source. Ten (10) studies showed an association between heavy metal exposure and renal impairment (p<0.05) while only 3 studies reported no association. Conclusion: Environmental monitoring is needed to stem the tide of heavy metal exposure in view of the growing burden of chronic kidney disease.
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Humanos , Masculino , Feminino , Metais Pesados , Exposição Ambiental , Insuficiência Renal Crônica , Revisão SistemáticaRESUMO
Complex abdominal wall reconstruction is an emerging subspecialty yet, despite the abundance of abdominal wall hernias requiring treatment and the increasing complexity of this type of surgery, there are few opportunities for surgeons to gain subspecialist training in this field. In this paper we discuss the need for focused training in complex abdominal wall reconstruction, outline some of the problems that may be hindering the availability of such opportunities and propose potential solutions to these issues.
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AIMS: Patient factors affect the risk of radiotherapy toxicity, but many are poorly defined. Studies have shown that race affects cancer incidence, survival, drug response, molecular pathways and epigenetics. Effects on radiosensitivity and radiotherapy toxicity are not well studied. The aim of the present study was to identify the effects of race and ethnicity on the risk of radiotherapy toxicity. MATERIALS AND METHODS: A systematic review was carried out of PubMed, Ovid Medline and Ovid Embase with no year limit. PRISMA 2020 guidelines were followed. Two independent assessors reviewed papers. RESULTS: Of 607 papers screened, 46 fulfilled the inclusion criteria. Papers were published between 1996 and 2021 and involved 30-28,354 individuals (median 433). Most involved patients with prostate (33%), breast (26%) and lung (9%) cancer. Both early and late toxicities were studied. Some studies reported a higher risk of toxicity in White men with prostate cancer compared with other races and ethnicities. For breast cancer patients, some reported an increased risk of toxicity in White women compared with other race and ethnic groups. In general, it was difficult to draw conclusions due to insufficient reporting and analysis of race and ethnicity in published literature. CONCLUSIONS: Reporting of race and ethnicity in radiotherapy studies must be harmonised and improved and frameworks are needed to improve the quality of reporting. Further research is needed to understand how ancestral heritage might affect radiosensitivity and risk of radiotherapy toxicity.
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Neoplasias da Próstata , Lesões por Radiação , Etnicidade/genética , Humanos , Incidência , Masculino , Neoplasias da Próstata/genética , Neoplasias da Próstata/radioterapiaRESUMO
OBJECTIVE: This project is designed to examine the prevalence of skeletal pathology in two archaeological avian bone assemblages. MATERIALS: Archaeological avian bone assemblages with Number of Identified Specimens of 14,909 (UNL-055) and 36,866 (UNL-048). METHODS: Visual examination of humeri, coracoids, tarsometatarsi, and cranial elements for pathology during taxonomic identification. RESULTS: 83 instances of skeletal pathology were observed in these assemblages and were most prevalent in the UNL-048 assemblage. Marginal osteophytes around the articular surfaces of the coracoid were the primary bone pathology in the UNL-048 avian assemblage. CONCLUSIONS: The prevalence of osteoarthritis in surface diving birds at the UNL-048 site could be due to changing climate. SIGNIFICANCE: Considering the environmental factors that contribute to instances of animal pathology allows for a more contextual interpretation of the cultural processes that occurred at archaeological sites. LIMITATIONS: Time and budgetary constraints did not allow for examination of the entire avian assemblage. SUGGESTIONS FOR FUTURE RESEARCH: Further intensive review of archaeological avian assemblages alongside consideration of environmental and cultural processes occurring during the site occupation is advised.
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Camada de Gelo , Osteoartrite , Alaska , Animais , Aves , CrânioRESUMO
We compared cardiopulmonary responses to arm-ergometry in individuals with cervical spinal cord injury (C-SCI) and able-bodied controls. We hypothesized that individuals with C-SCI would have higher respiratory frequency (fb) but lower tidal volume (VT) at a given work rate and dynamically hyperinflate during exercise, whereas able-bodied individuals would not. Participants completed pulmonary function testing, an arm-ergometry test to exhaustion, and a sub-maximal exercise test consisting of four-minute stages at 20, 40, 60, and 80% peak work rate. Able-bodied individuals completed a further sub-maximal test with absolute work rate matched to C-SCI. During work rate matched sub-maximal exercise, C-SCI had smaller VT (main effect p < 0.001) compensated by an increased fb (main effect p = 0.009). C-SCI had increased end-expiratory lung volume at 80% peak work rate vs. rest (p < 0.003), whereas able-bodied did not. In conclusion, during arm-ergometry, individuals with C-SCI exhibit altered ventilatory patterns characterized by reduced VT, higher fb, and dynamic hyperinflation that may contribute to the observed reduced aerobic exercise capacity.
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Braço/fisiopatologia , Medula Cervical/lesões , Exercício Físico/fisiologia , Expiração/fisiologia , Taxa Respiratória/fisiologia , Traumatismos da Medula Espinal/fisiopatologia , Sistema Nervoso Simpático/fisiopatologia , Volume de Ventilação Pulmonar/fisiologia , Adulto , Feminino , Humanos , MasculinoRESUMO
Radiotherapy plays an essential role in the curative treatment of muscle-invasive bladder cancer (MIBC). Hypoxia affects the response to MIBC radiotherapy, limiting radiocurability. Likewise, hypoxia influences MIBC genetic instability and malignant progression being associated with metastatic disease and a worse prognosis. Hypoxia identification in MIBC enables treatment stratification and the promise of improved survival. The most promising methods are histopathological markers such as necrosis; biomarkers of protein expression such as HIF-1α, GLUT-1 and CAIX; microRNAs; and novel mRNA signatures. Although hypoxia modification can take different forms, the gold standard remains carbogen and nicotinamide, which improve local control rates in bladder preservation and absolute overall survival with no significant increase in late toxicity. This is an exciting time for evolving therapies such as bioreductive agents, novel oxygen delivery techniques, immunotherapy and poly (ADP-ribose) polymerase 1 (PARP) inhibitors, all in development and representing upcoming trends in MIBC hypoxia modification. Whatever the future holds for hypoxia-modified radiotherapy, there is no doubt of its importance in MIBC. mRNA signatures provide an ideal platform for the selection of those with hypoxic tumours but are yet to qualified and integrated into the clinic. Future interventional trials will require biomarker stratification to ensure optimal treatment response to improve outcomes for patients with MIBC.
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Neoplasias da Bexiga Urinária , Biomarcadores , Humanos , Hipóxia , Prognóstico , Neoplasias da Bexiga Urinária/genética , Neoplasias da Bexiga Urinária/terapiaRESUMO
PURPOSE: For oropharynx squamous cell carcinoma (OPSCC) this study aimed to: (i) compare 5-year overall survival (OS) stratification by AJCC/UICC TNM versions 7 (TNMv7) and 8 (TNMv8), (ii) determine whether changes to T and N stage groupings improve prognostication and (iii) develop and validate a model incorporating additional clinical characteristics to improve 5-year OS prediction. MATERIAL AND METHODS: All OPSCC treated with curative-intent at our institution between 2011 and 2017 were included. The primary endpoint was 5-year OS. Survival curves were produced for TNMv7 and TNMv8. A three-way interaction between T, N stage and p16 status was evaluated for improved prognostication. Cox proportional hazards modelling was used to derive a new predictive model. RESULTS: Of 750 OPSCC cases, 574 (77%) were p16-positive. TNMv8 was more prognostic than TNMv7 (concordance probability estimate [CPE]⯱â¯SEâ¯=â¯0.72⯱â¯0.02 vs 0.53⯱â¯0.02). For p16-positive disease, TNMv8 discriminated stages II vs I (HR 2.32, 95% CI 1.47-3.67) and III vs II (HR 1.75, 95% CI 1.13-2.72). For p16-negative disease, TNMv7 and TNMv8 demonstrated poor hazard discrimination. Different T, N stage and p16-status combinations did not improve prognostication after adjusting for other factors (CPEâ¯=â¯0.79 vs 0.79, pâ¯=â¯0.998). A model for p16-positive and p16-negative OPSCC including additional clinical characteristics improved 5-year OS prediction beyond TNMv8 (c-index 0.76⯱â¯0.02). CONCLUSIONS: TNMv8 is superior to TNMv7 for p16-positive OPSCC, but both performed poorly for p16-negative disease. A novel model incorporating additional clinical characteristics improved 5-year OS prediction for both p16-positive and p16-negative disease.
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Neoplasias Orofaríngeas/mortalidade , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Neoplasias Orofaríngeas/patologia , PrognósticoRESUMO
INTRODUCTION: Auto contouring models help consistently define volumes and reduce clinical workload. This study aimed to evaluate the cross acquisition of a Magnetic Resonance (MR) deep learning auto contouring model for organ at risk (OAR) delineation in head and neck radiotherapy. METHODS: Two auto contouring models were evaluated using deep learning contouring expert (DLCExpert) for OAR delineation: a CT model (modelCT) and an MR model (modelMRI). Models were trained to generate auto contours for the bilateral parotid glands and submandibular glands. Auto-contours for modelMRI were trained on diagnostic images and tested on 10 diagnostic, 10 MR radiotherapy planning (RTP), eight MR-Linac (MRL) scans and, by modelCT, on 10 CT planning scans. Goodness of fit scores, dice similarity coefficient (DSC) and distance to agreement (DTA) were calculated for comparison. RESULTS: ModelMRI contours improved the mean DSC and DTA compared with manual contours for the bilateral parotid glands and submandibular glands on the diagnostic and RTP MRs compared with the MRL sequence. There were statistically significant differences seen for modelMRI compared to modelCT for the left parotid (mean DTA 2.3 v 2.8 mm), right parotid (mean DTA 1.9 v 2.7 mm), left submandibular gland (mean DTA 2.2 v 2.4 mm) and right submandibular gland (mean DTA 1.6 v 3.2 mm). CONCLUSION: A deep learning MR auto-contouring model shows promise for OAR auto-contouring with statistically improved performance vs a CT based model. Performance is affected by the method of MR acquisition and further work is needed to improve its use with MRL images.
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Aprendizado Profundo , Neoplasias de Cabeça e Pescoço , Cabeça , Neoplasias de Cabeça e Pescoço/diagnóstico por imagem , Neoplasias de Cabeça e Pescoço/radioterapia , Humanos , Espectroscopia de Ressonância Magnética , Planejamento da Radioterapia Assistida por ComputadorRESUMO
INTRODUCTION: Haemorrhage is the major cause of early mortality following traumatic injury. Patients suffering from non-compressible torso haemorrhage are more likely to suffer early death. Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) can be effective in initial resuscitation; however, establishing swift arterial access is challenging, particularly in a severe shock. This is made more difficult by anatomical variability of the femoral vessels. METHODS: The femoral vessels were characterised in 81 cadaveric lower limbs, measuring specifically the distance from the inferior border of the inguinal ligament to the distal part of the origin of the profunda femoris artery (PFA), and from the distal part of the origin of the PFA to where the femoral vein lies posterior to and is completely overlapped by the femoral artery. RESULTS: The femoral vein lay deep to the femoral artery at a mean distance of 105 mm from the inferior border of the inguinal ligament. The PFA arose from the femoral artery at a mean distance of 51.1 mm from the inguinal ligament. From the results, it is predicted that the PFA originates from the common femoral artery approximately 24 mm from the inguinal ligament, and the femoral vein is completely overlapped by the femoral artery by 67.7 mm distal from the inguinal ligament, in 95% of subjects. CONCLUSIONS: Based on the results, proposed is an 'optimal access window' of up to 24 mm inferior to the inguinal ligament for common femoral arterial catheterisation for pre-hospital REBOA, or more simply within one finger breadth.
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Oclusão com Balão , Procedimentos Endovasculares , Aorta Abdominal , Cadáver , Artéria Femoral , HumanosRESUMO
At the time of writing, coronavirus disease-2019 (COVID-19) has affected 6.42 million people globally and over 380,000 deaths, with the United Kingdom now having the highest death rate in Europe. The plastic surgery department at Leeds Teaching Hospitals put necessary steps in place to maintain an excellent urgent elective and acute service whilst also managing COVID-positive medical patients in the ward. We describe the structures and pathways implemented together with complex decision-making, which has allowed us to respond early and effectively. We hope these lessons will prove a useful tool as we look to open conversations around the recovery of normal activity.