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BACKGROUND: To prevent anaphylaxis-associated illness, intramuscular epinephrine injection is recommended. Subcutaneous injection may reduce efficacy, and intraosseous injection promotes morbidity. A few studies suggested that commercially available thigh epinephrine autoinjectors (EAIs) may induce subcutaneous/intraosseous injection in some adults. OBJECTIVE: To estimate the subcutaneous/intraosseous-injection rates of 4 EAIs by comparing their needle lengths with the ultrasound-measured skin-to-muscle depth and skin-to-bone depth of the midthigh of adults with allergic diseases in a cross-sectional study and to determine patient factors that predict subcutaneous EAI injection. METHODS: Thigh ultrasound was conducted in a convenience-recruited cohort with minimal and maximal compression to estimate the effect of EAI-induced compression. Subcutaneous/intraosseous-injection rates were estimated for Anapen (BioProject), EpiPen (Mylan), Jext (ALK), and Emerade (Medeca). Multivariate analyses for subcutaneous-injection risk were conducted with age, male/female sex, abdominal and thigh circumferences, and upper-arm skinfold thickness. RESULTS: A total of 68 patients were recruited. Compression thinned the subcutaneous tissue and muscle by 1 and 9 mm, respectively, on average. Projected subcutaneous-injection rates with/without compression were high for Anapen (65%-66%), moderate for EpiPen and Jext (29%-38%), and lowest for Emerade (13%-21%). Compression introduced a small intraosseous-injection risk with Emerade (4%). Female sex predicted subcutaneous injection (odds ratio, 1.3-2.0; all P < .001). Depending on the EAI, 29% to 97% of women and 0% to 41% of men would be injected subcutaneously. Older men were at risk of intraosseous Emerade injection. Obesity-related variables predicted subcutaneous injection poorly. CONCLUSION: Anapen was associated with high subcutaneous-injection rates. EpiPen and Jext were projected to provide intramuscular injection in all men without risk of intraosseous injection. Emerade yielded the lowest subcutaneous-injection rates in women. Compression largely affected the muscle. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02886468.
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Anafilaxia , Epinefrina , Humanos , Masculino , Feminino , Adulto , Epinefrina/administração & dosagem , Injeções Subcutâneas/instrumentação , Pessoa de Meia-Idade , Anafilaxia/tratamento farmacológico , Estudos Transversais , Coxa da Perna , Ultrassonografia , Idoso , Injeções Intramusculares/instrumentação , Injeções Intramusculares/métodos , Adulto JovemRESUMO
BACKGROUND: A comprehensive analysis of routinely collected pre/perioperative demographic/clinical factors that could predict final visual acuity after primary Descemet membrane endothelial keratoplasty (DMEK) has not been conducted previously. METHODS: A retrospective monocenter cohort study was performed with consecutive patients with Fuchs endothelial corneal dystrophy (FECD) who underwent DMEK or triple-DMEK (DMEK combined with cataract surgery) in 2016-2020 in a French tertiary-care hospital. DMEK-only patients were pseudophakic. Patients were followed for 12 months. Surgery was considered successful when 12-month best-corrected visual acuity (BCVA) was ≤0.1 logMAR (≥0.8). Exploratory multivariate analysis was conducted with the following routinely collected variables to determine their ability to predict 12-month BCVA: patient age and sex; graft donor age; triple DMEK; preoperative values of BCVA, endothelial cell density (ECD), central corneal thickness (CCT), and mean anterior keratometry; and rebubbling. RESULTS: Of 100 eyes (100 patients; mean age, 72 years; 61% female), 81 achieved a 12-month BCVA of ≤0.1 logMAR. Logistic regression analysis showed that older age was a significant prognosticator for 12-month BCVA > 0.1 logMAR (Odds Ratio = 0.914, 95% confidence intervals = 0.846-0.987; p = 0.02). CONCLUSIONS: An older age associated with worse visual acuity outcomes after DMEK. This was confirmed by our analysis of the literature and supports the notion that DMEK should be conducted without delay once symptoms appear. Patient sex, donor age, triple-DMEK, and anterior keratometry also did not predict final BCVA in the literature. Preoperative CCT, ECD, and BCVA, and rebubbling occasionally appear in the literature as BCVA predictors, possibly reflecting an underlying ECD-BCVA axis.
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Ceratoplastia Endotelial com Remoção da Lâmina Limitante Posterior , Distrofia Endotelial de Fuchs , Idoso , Contagem de Células , Estudos de Coortes , Lâmina Limitante Posterior/cirurgia , Ceratoplastia Endotelial com Remoção da Lâmina Limitante Posterior/métodos , Endotélio Corneano , Feminino , Distrofia Endotelial de Fuchs/diagnóstico , Distrofia Endotelial de Fuchs/cirurgia , Humanos , Masculino , Estudos RetrospectivosRESUMO
BACKGROUND: Prone positioning (PP) is a standard of care for patients with moderate-severe acute respiratory distress syndrome (ARDS). While adverse events associated with PP are well-documented in the literature, research examining the effect of PP on the risk of infectious complications of intravascular catheters is lacking. METHOD: All consecutive ARDS patients treated with PP were recruited retrospectively over a two-year period and formed the exposed group. Intensive care unit (ICU) patients during the same period without ARDS for whom PP was not conducted but who had an equivalent disease severity were matched 1:1 to the exposed group based on age, sex, centre, length of ICU stay and SAPS II (unexposed group). Infection-related catheter complications were defined by a composite criterion, including catheter tip colonization or intravascular catheter-related infection. RESULTS: A total of 101 exposed patients were included in the study. Most had direct ARDS (pneumonia). The median [Q1-Q3] PP session number was 2 [1-4]. These patients were matched with 101 unexposed patients. The mortality rates of the exposed and unexposed groups were 31 and 30%, respectively. The incidence of the composite criterion was 14.2/1000 in the exposed group compared with 8.2/1000 days in the control group (p = 0.09). Multivariate analysis identified PP as a factor related to catheter colonization or infection (p = 0.04). CONCLUSION: Our data suggest that PP is associated with a higher risk of CVC infectious complications.
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Infecções Relacionadas a Cateter/etiologia , Posicionamento do Paciente/efeitos adversos , Síndrome do Desconforto Respiratório/complicações , Idoso , Cuidados Críticos , Feminino , Humanos , Incidência , Unidades de Terapia Intensiva , Masculino , Pessoa de Meia-Idade , Decúbito Ventral , Síndrome do Desconforto Respiratório/terapia , Estudos Retrospectivos , Índice de Gravidade de DoençaRESUMO
BACKGROUND: The subcutaneous route is widely used in both palliative care and geriatrics. Numerous compounds are administered by this route, including paracetamol. However, there is no recommendation on which to base this latter practice and, in the absence of published evidence, nothing is known regarding its local tolerability in palliative care patients. AIM: The main objective of this study was to assess the local tolerability of paracetamol when administered subcutaneously for analgesic or antipyretic purposes in patients hospitalized in the palliative care unit. The secondary objective was to identify the factors favoring the occurrence of local adverse events. DESIGN: This is a prospective multicenter observational study (NCT02884609). PARTICIPANTS: Study conducted in 160 patients hospitalized in the palliative care units of three hospitals in metropolitan France from 2014 to 2017. RESULTS: Of the 160 patients, 44 (28%) presented at least one non-serious local adverse event (edema in 29, erythema in 5, pain in 15, hematoma in 2, pruritus in 1, and local heat in 2). No serious adverse events were observed. Factors associated with the occurrence of local adverse events were younger age, administration in the arm and thorax, and a high number of daily administrations. CONCLUSION: This first ever study carried out on this subject reveals that subcutaneous administration of paracetamol in palliative care patients was well tolerated locally.
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Acetaminofen/administração & dosagem , Analgésicos não Narcóticos/administração & dosagem , Dor/tratamento farmacológico , Cuidados Paliativos/métodos , Acetaminofen/efeitos adversos , Adulto , Idoso , Idoso de 80 Anos ou mais , Analgésicos não Narcóticos/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos ProspectivosRESUMO
BACKGROUND: Totally implantable venous access port (TIVAP)-related infections (RIs) remain a serious health problem in cancer patients receiving an intravenous (i.v.) therapy. PATIENTS AND METHODS: The ATAPAC study was a prospective, randomized, monocentric, phase IV trial evaluating the efficacy of taurolidine lock solution versus standard saline solution for primary TIVAP-RI prevention in nonhematological cancer patients receiving i.v. chemotherapy. The primary endpoint was the TIVAP-RI incidence rate. From December 2014 to September 2015, 163 patients were enrolled in the study (taurolidine: n = 86 vs. CONTROL: n = 77). Four patients in the control group (5%) had a Staphylococcus epidermidis TIVAP-RI, and 1 patient (1%) in the taurolidine group had a Staphylococcus aureus infection. The TIVAP-RI incidence rate was 0.4 and 0.1 catheter-days, respectively (p = 0.21). The infection-free TIVAP survival was not statistically significant (p = 0.09). TIVAP-RI required a total of 22 hospitalization days in the taurolidine group versus 106 days in the control arm with associated costs of EUR 4,849 and EUR 36,020, respectively. Taurolidine-related toxicity was transitory and classified as grade I. CONCLUSIONS: The ATAPAC trial did not show a significant risk-infection reduction by TauroLock™. A larger, prospective, randomized trial is needed to assess TauroLock efficacy for primary TIVAP-RI prevention in low-risk cancer patients.
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Anti-Infecciosos/farmacologia , Biofilmes/efeitos dos fármacos , Infecções Relacionadas a Cateter/prevenção & controle , Cateteres de Demora/microbiologia , Cateteres Venosos Centrais/microbiologia , Neoplasias/tratamento farmacológico , Prevenção Primária/métodos , Taurina/análogos & derivados , Tiadiazinas/farmacologia , Idoso , Infecções Relacionadas a Cateter/microbiologia , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Taurina/farmacologia , Resultado do TratamentoRESUMO
BACKGROUND: Custom-made transparent facial orthoses (TFOs) (face masks) are used to improve facial burn scars. We conducted a systematic literature review on TFO manufacture and use. METHODS: Pubmed and Cochrane databases were searched without restrictions for relevant articles. TFO manufacture details and use according to international recommendations (20-32 mmHg pressure, TFO worn 20-23 h/day for ≥2 months) were extracted. RESULTS: Of 279 retrieved articles, 11 published over the last 41 years (four in the last 5 years) discussed TFO manufacture/use. There were five technical notes, five case reports, and a patient-cohort study (total patients in the studies=21). TFO-manufacture methods could be categorized as classical, digital, or mixed classical-digital. Relative clinical efficacies and cost advantages were unclear. The plastics used, harness materials, harness-point number, and silicone-interface use differed from study to study. Target pressure, actual pressure, expected daily wearing time, and treatment duration ranged widely and often did not meet current guidelines. Actual wearing time and treatment duration were never measured. CONCLUSIONS: Although TFOs play an important global role in burn care, there is a grave paucity of research. Further research is needed to promote the standardization of TFO-related practices and thereby improve the outcomes of facial-burn patients.
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Queimaduras , Cicatriz Hipertrófica , Traumatismos Faciais , Lesões do Pescoço , Humanos , Queimaduras/complicações , Queimaduras/terapia , Cicatriz Hipertrófica/etiologia , Estudos de Coortes , Traumatismos Faciais/terapia , Traumatismos Faciais/complicações , Máscaras , Lesões do Pescoço/complicações , PressãoRESUMO
PURPOSE: Principal component analysis (PCA) is a descriptive exploratory statistical technique that is widely used in complex fields for data mining. However, it is rarely used in ophthalmology. We explored its research potential with a large series of eyes that underwent 3 keratoplasty techniques: Descemet membrane endothelial keratoplasty (DMEK), conventional Descemet stripping automated endothelial keratoplasty (ConDSAEK), or ultrathin-DSAEK (UT-DSAEK). METHODS: All consecutive DMEK/DSAEK cases conducted in 2016 to 2022 that had ≥24 months of follow-up were included. ConDSAEK and UT-DSAEK were defined as preoperative central graft thickness ≥130 and <130 µm, respectively. Seventy-six patient, disease, surgical practice, and temporal outcome variables were subjected to PCA, including preoperative anterior keratometry, the use of sulfur hexafluoride gas (SF6) versus air for primary tamponade, and postoperative best corrected visual acuity and endothelial cell density. Associations of interest that were revealed by PCA were assessed with the Welch t test or Pearson test. RESULTS: A total of 331 eyes were treated with DMEK (n = 165), ConDSAEK (n = 95), or UT-DSAEK (n = 71). PCA showed that ConDSAEK and UT-DSAEK clustered closely, including regarding postoperative best corrected visual acuity, and were clearly distinct from DMEK. PCA and follow-up univariate analyses suggested that in DMEK, 1) flatter preoperative anterior keratometry (average, K1, and K2) associated with more rebubbling (P = 0.004-0.089) and graft detachment (P = 0.007-0.022); 2) graft marking did not affect postoperative ECD; and 3) lower postoperative endothelial cell density associated with SF6 use (all P > 0.001) and longer surgery (P = 0.005-0.091). All associations are currently under additional investigation in our hospital. CONCLUSIONS: PCA is a powerful technique that can rapidly reveal clinically relevant associations in complex ophthalmological datasets.
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PURPOSE: Identifying pre/perioperative factors that predict corneal endothelial-cell loss (ECL) after phacoemulsification may reveal ways to reduce ECL. Our literature analysis showed that 37 studies have investigated one or several such factors but all have significant limitations. Therefore, the data of a large randomized controlled trial (PERCEPOLIS) were subjected to post-hoc multivariate analysis determining the ability of nine pre/perioperative variables to predict ECL. METHODS: PERCEPOLIS was conducted in 2015-2016 to compare two phacoemulsification techniques (subluxation and divide-and-conquer) in terms of 3-month ECL. Non-inferiority between the techniques was found. In the present study, post-hoc univariate and multivariate analyses were conducted to determine associations between ECL and age, sex, cataract density, preoperative endothelial-cell density, phacoemulsification technique, effective phaco time (EPT), and 2-hour central-corneal thickness. The data are presented in the context of a narrative review of the literature. RESULTS: Three-month data were available for 275 patients (94% of the randomized cohort; mean age, 74 years; 58% women). Mean LOCSIII cataract grade was 3.2. Mean EPT was 6 seconds. Mean ECL was 13%. Only an older age (beta = 0.2%, p = 0.049) and higher EPT (beta = 1.2%, p = 0.0002) predicted 3-month ECL. Cataract density was significant on univariate (p = 0.04) but not multivariate analysis. The other variables did not associate with ECL. CONCLUSIONS: Older age may amplify ECL due to increased endothelial cell fragility. EPT may promote ECL via cataract density-dependent and -independent mechanisms that should be considered in future phacoemulsification research aiming to reduce ECL. Our literature analysis showed that the average ECL for relatively unselected consecutively-sampled cohorts is 12%.
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Extração de Catarata , Catarata , Facoemulsificação , Humanos , Feminino , Idoso , Masculino , Facoemulsificação/efeitos adversos , Facoemulsificação/métodos , Perda de Células Endoteliais da Córnea/diagnóstico , Perda de Células Endoteliais da Córnea/etiologia , Extração de Catarata/efeitos adversos , Extração de Catarata/métodos , Implante de Lente Intraocular , Contagem de Células , Endotélio Corneano , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
INTRODUCTION: Enhanced recovery after surgery (ERAS) protocols increase patient well-being while significantly reducing mortality, costs and length-of-stay after surgery. A key component is multimodal analgesia that prevents postoperative pain and facilitates early refeeding and mobilisation. Thoracic epidural analgesia (TEA) was long the gold standard for locoregional anaesthesia in anterior abdominal wall surgery. However, newer wall-block techniques such as rectus-sheath block (RSB) may be preferable because they are less invasive and may provide equivalent analgesia with fewer side effects. Since the evidence base remains limited, the Quality Of Recovery enhanced by REctus sheat CATHeter (QoR-RECT-CATH) randomised controlled trial (RCT) was designed to assess whether RSB elicits better postoperative rehabilitation than TEA after laparotomy. METHODS AND ANALYSIS: This open-label parallel-arm 1:1-allocated RCT will determine whether RSB is superior to TEA in 110 patients undergoing scheduled midline laparotomy in terms of postoperative rehabilitation quality. The setting is a regional French hospital that provides opioid-free anaesthesia for all laparotomies within an ERAS programme. Recruited patients will be ≥18 years, scheduled to undergo laparotomy, have American Society of Anesthesiologists (ASA) score 1-4 and lack contraindications to ropivacaine/TEA. TEA-allocated patients will receive an epidural catheter before surgery while RSB-allocated patients will receive rectus sheath catheters after surgery. All other pre/peri/postoperative procedures will be identical, including multimodal postoperative analgesia provided according to our standard of care. Primary objective is a change in total Quality-of-Recovery-15 French-language (QoR-15F) score on postoperative day (POD) 2 relative to baseline. QoR-15F is a patient-reported outcome measure that is commonly used to measure ERAS outcomes. The 15 secondary objectives include postoperative pain scores, opioid consumption, functional recovery measures and adverse events. ETHICS AND DISSEMINATION: The French Ethics Committee (Sud-Ouest et Outre-Mer I Ethical Committee) gave approval. Subjects are recruited after providing written consent after receiving the information provided by the investigator. The results of this study will be made public through peer-reviewed publication and, if possible, conference publications. TRIAL REGISTRATION NUMBER: NCT04985695.
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Parede Abdominal , Analgesia Epidural , Anestesia Epidural , Anestesiologia , Humanos , Procedimentos Cirúrgicos Eletivos , Analgésicos Opioides , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
OBJECTIVE: To evaluate the value of hematocrit for monitoring fluid resuscitation of burn patients in the acute phase of their care. METHOD: We conducted a single-center retrospective study focused on patients admitted with a burn surface of more than 20 % of the total body surface area (TBSA) from 2014 to 2021. We investigated the relationship between the change in hematocrit and the volume administered for patient resuscitation. The change in hematocrit is the difference between an admission hematocrit and a second one taken between the eighth and twenty-fourth hour. RESULTS: We included 230 patients with an average burn size of 39.1 ± 20.3 % TBSA, in 94.4 % by a thermal mechanism. The management seems to be in accordance with the current recommendations, with a volume administered during the first 24 h of 4.3 ± 2.5 ml/kg/ % BSA, allowing to obtain an hourly diuresis of 0.9 ± 0.7 ml/kg/h. We did not find any correlation between the pre-hospital volume administration and the hematocrit at admission (p = 0.36). Hematocrit decreased on average to -4.5 ± 8.1 % between admission and a control performed after the 8th hour. This decrease was weakly correlated with the volumes infused between the two samples (r2 =0.13, p < 0.001). A resuscitation above 5.2 ml/kg/ % Burn surface area is an independent factor for excess mortality. CONCLUSION: Hematocrit or its variations in our limited data base appears to not reliably detect over-resuscitation, therefore it is possible that it may not be a relevant marker. These conclusions should be clarified in a multi-institutional prospective or real-world analysis to validate the findings and null hypothesis.
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Queimaduras , Humanos , Estudos Retrospectivos , Estudos Prospectivos , Hematócrito , Hidratação , RessuscitaçãoRESUMO
PURPOSE: The long-term clinical outcomes, postoperative complications, and graft survival of Descemet-membrane endothelial keratoplasty (DMEK) remain poorly understood. We retrospectively assessed these variables in all consecutive eyes that underwent DMEK for any indication in 2014-2018. The findings were compared to the long-term DMEK studies of five other groups (3-10-year follow-up). METHODS: Patients underwent ophthalmological tests preoperatively, at 1, 3, 6, and 12 postoperative months, and then annually. Five-year graft survival was determined by Kaplan-Meier estimator. Change in best-corrected visual acuity (BCVA), endothelial-cell density (ECD), and central-corneal thickness (CCT) at each timepoint was determined. RESULTS: 107 eyes (80 patients; 72 years old; 67% female) underwent first-time DMEK for uncomplicated Fuchs endothelial corneal dystrophy (94% of eyes), pseudophakic bullous keratopathy (3%), and regraft after previous keratoplasty (3%). The most common complication was graft detachment requiring rebubbling (18%). Thirteen grafts (12%) failed at ≤15 months. Cumulative 5-year graft-survival probability was 88% (95% confidence intervals = 79-94%). BCVA improved from 0.6 logMAR preoperatively to 0.05 logMAR at 1 year (p<0.0001) and then remained stable. Donor ECD dropped by 47% at 6 postoperative months and then continued to decrease by 4.0%/year. Five-year endothelial-cell loss was 65% (from 2550 to 900 cells/mm2). CCT dropped from 618 to 551 µm at 5 years (p<0.0001). These findings are generally consistent with previous long-term DMEK studies. CONCLUSIONS: DMEK has low complication and high graft-survival rates and excellent clinical outcomes that persist up to 5 years post-surgery. DMEK seems to be a safe and effective treatment in the long term.
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Ceratoplastia Endotelial com Remoção da Lâmina Limitante Posterior , Distrofia Endotelial de Fuchs , Humanos , Feminino , Idoso , Masculino , Endotélio Corneano/cirurgia , Estudos Retrospectivos , Ceratoplastia Endotelial com Remoção da Lâmina Limitante Posterior/efeitos adversos , Paquimetria Corneana , Contagem de Células , Acuidade Visual , Distrofia Endotelial de Fuchs/cirurgia , Sobrevivência de Enxerto , Lâmina Limitante Posterior/cirurgiaRESUMO
Descemet membrane endothelial keratoplasty (DMEK) restores visual acuity in patients with progressive corneal endothelial diseases such as Fuchs endothelial corneal dystrophy (FECD). However, patients often prefer to delay the surgery as long as possible, even though outcomes are poorer in advanced FECD. A recent study proposed that preoperative central corneal thickness (CCT) of ≥625 µm associated with worse best spectacle-corrected visual acuity (BSCVA) after DMEK for FECD. Since this threshold could signal to both surgeons and patients when to perform DMEK, we further explored the relationship between CCT and BSCVA with a retrospective cohort study. The cohort consisted of all patients with FECD who underwent DMEK in a tertiary-care hospital in 2015-2020 and were followed for 12 months. Extremely decompensated corneas were not included. Relationships between preoperative CCT and BSCVA on days 8 and 15 and months 1, 3, 6, and 12 were examined with Pearson correlation analyses. Eyes with preoperative CCT <625 or ≥625 µm were also compared in terms of postoperative BSCVA. Relationships between postoperative CCT and final BSCVA were also explored. The cohort consisted of 124 first-operated eyes. Preoperative CCT did not correlate with postoperative BSCVA at any timepoint. Eye subgroups did not differ in postoperative BSCVA. However, postoperative CCT at 1-12 months correlated significantly with 12-month BSCVA (r = 0.29-0.49, p = 0.020-0.001). Thus, postoperative, but not preoperative, CCT correlated with postoperative BSCVA. This phenomenon may reflect factors that distort preoperative CCT measurements but disappear after surgery. This observation and our analysis of the literature suggest that while there is a relationship between CCT and post-DMEK visual acuity, preoperative CCT measurements may not always adequately reflect that relationship and may therefore not be a reliable predictor of DMEK visual outcomes.
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Doenças da Córnea , Transplante de Córnea , Distrofia Endotelial de Fuchs , Humanos , Lâmina Limitante Posterior , Estudos Retrospectivos , CórneaRESUMO
INTRODUCTION: The enhanced recovery after surgery (ERAS) programmes following hysterectomies have been studied since 2010, and their positive effects on clinical or economic criteria are now well established. However, the benefits on health outcomes, especially rapid recovery after surgery from patients' perspective is lacking in literature, leading to develop scores supporting person-centred and value-based care such as patient-reported outcome measures. The aim of this study is to assess the impact of an ERAS programme on patients' well-being after undergoing hysterectomy. METHODS AND ANALYSIS: This is an observational, prospective single-centre before-after clinical trial. 148 patients are recruited and allocated into two groups, before and after ERAS programme implementation, respectively. The ERAS programme consists in optimising factors dealing with early rehabilitation, such as preoperative patient education, multimodal pain management, early postoperative fluid taken and mobilisation. A self-questionnaire quality of recovery-15 (QoR-15) on the preoperative day 1 (D-1), postoperative day 0 evening (D0) and the postoperative day 1 (D+1) is completed by patients. Patients scheduled to undergo hysterectomy, aged 18 years and above, whose physical status are classified as American Society of Anesthesiologists score 1-3 and who are able to return home after being discharged from hospital and contact their physician or the medical department if necessary are recruited for this study. The total duration of inclusion is 36 months. The primary outcome is the difference in QoR-15 scores measured on D+1 which will be compared between the 'before' and the 'after' group, using multiple linear regression model. ETHICS AND DISSEMINATION: Approval was obtained from the Ethical Committee (Paris, France). Subjects are actually being recruited after giving their oral agreement or non-objection to participate in this clinical trial and following the oral and written information given by the anaesthesiologist practitioner.Trial registration number: ClinicalTrials.gov: NCT04268576 (Pre-result).
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Recuperação Pós-Cirúrgica Melhorada , Estudos Controlados Antes e Depois , Feminino , Humanos , Histerectomia , Tempo de Internação , Estudos Observacionais como Assunto , Estudos ProspectivosRESUMO
Previous comparative studies show that triple Descemet membrane endothelial keratoplasty (DMEK) (i.e. phacoemulsification followed immediately by DMEK) has either equivalent or better visual outcomes than DMEK in pseudophakic patients. To resolve this discrepancy, a retrospective cohort study was conducted. All consecutive patients with Fuchs Endothelial Corneal Dystrophy who underwent triple or pseudophakic DMEK in 2015-2019 in a tertiary-care hospital (France) and were followed for >12 months were compared in terms of best spectacle-corrected visual acuity (BSCVA), final refractive outcomes, and endothelial-cell loss at 12 months as well as rebubbling rates. The triple-DMEK (40 eyes, 34 patients) and pseudophakic-DMEK (55 eyes, 43 patients) groups were similar in terms of age and other baseline variables. They also did not differ in final BSCVA (both 0.03 logMAR), final endothelial-cell loss (54% vs. 48%), or astigmatism (-1.25 vs. -1 D). At 12 months, triple-DMEK associated with significantly smaller residual hyperopia (0.75 vs. 1 D; p = 0.04) and spherical equivalence (0 vs. 0.5 D; p = 0.02). Triple-DMEK also tended to associate with more frequent rebubbling (40% vs. 24%, p = 0.09). In conclusion, while triple-DMEK and pseudophakic-DMEK achieved similar visual acuity improvement, triple-DMEK was superior in terms of final sphere and spherical refraction but also tended to have higher complication rates.
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Ceratoplastia Endotelial com Remoção da Lâmina Limitante Posterior , Distrofia Endotelial de Fuchs , Contagem de Células , Estudos de Coortes , Lâmina Limitante Posterior/cirurgia , Endotélio Corneano , Distrofia Endotelial de Fuchs/cirurgia , Humanos , Estudos RetrospectivosRESUMO
PURPOSE: It remains unclear whether preoperative central graft thickness (CGT) contributes to visual outcomes of Descemet stripping automated endothelial keratoplasty (DSAEK). This retrospective cohort study examined the ability of preoperative and postoperative CGT to predict 12-month best spectacle-corrected visual acuity (BSCVA) after DSAEK for Fuchs endothelial corneal dystrophy/moderate pseudophakic bullous keratopathy/second graft. METHODS: All consecutive patients who underwent DSAEK in 2015 to 2018 were included. The primary end point was 12-month BSCVA. DSAEK-CGT was measured preoperatively and 6 times between postoperative day 8 and month 12. Eyes were divided according to preoperative CGT 130 µm (ultrathin-DSAEK threshold) or 6-month postoperative CGT 100 µm (mean 6-month postoperative DSAEK-CGT). The t test assessed CGT evolution of the 4 groups over time. Multivariate analyses examined whether preoperative CGT or 6-month CGT categories predicted 12-month BSCVA. Multivariate analysis assessed the preoperative/perioperative factors that predicted 6-month CGT. RESULTS: A total of 108 eyes (68 patients) underwent DSAEK. Preoperative CGT was >130 and ≤130 µm in 87 and 21 eyes, respectively. Postoperative CGT was >100 and ≤100 µm in 50 and 58 eyes, respectively. Thin 6-month postoperative grafts thinned significantly more relative to preoperative thickness than thick grafts ( P < 0.001). Preoperative CGT subgroups did not show this difference. Six-month postoperative CGT ( P = 0.01), but not preoperative CGT, predicted 12-month BSCVA. Preoperative CGT strongly predicted 6-month CGT ( P = 0.0003). CONCLUSIONS: Postoperative, but not preoperative, DSAEK-CGT predicted 6-month BSCVA. The correlation between preoperative and postoperative CGT and interstudy variation in preoperative CGT measurement accuracy may explain literature disparities regarding the importance of preoperative CGT in DSAEK outcomes.
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Ceratoplastia Endotelial com Remoção da Lâmina Limitante Posterior , Distrofia Endotelial de Fuchs , Estudos de Coortes , Endotélio Corneano/transplante , Distrofia Endotelial de Fuchs/cirurgia , Humanos , Estudos Retrospectivos , Acuidade VisualRESUMO
PURPOSE: Subluxation techniques are superior to divide-and-conquer in procedure duration, pain, and ultrasound quantity, but their safety in endothelial cell loss (ECL) is unclear. This randomized single-blind noninferiority clinical trial aimed to determine whether subluxation supracapsular phacoemulsification techniques are inferior to a reference endocapsular technique (divide-and-conquer) regarding postoperative corneal ECL. METHODS: Patients (aged18 years or older) with greater than +0.2 logarithm of the minimum angle of resolution best spectacle-corrected visual acuity and normal to severe density cataract were randomized to subluxation or divide-and-conquer phacoemulsification in 2015 to 2016. Follow-up with ophthalmic tests was conducted on day 4 and months 1, 3, and 12. The primary study outcome was ECL at all time points. Secondary study end points were operative variables, including effective phaco time and procedure duration. A clinically relevant noninferiority ECL limit was established on the basis of the literature. RESULTS: In total, 292 patients (mean age, 73 yrs; 59% female) were randomized and underwent subluxation (n = 148) or divide-and-conquer (n = 144). Day 4 and month 1, 3, and 12 data were available for 243, 270, 275, and 198 patients, respectively. The unexpectedly high dropout at 12 months meant that the 12-month ECL data could only be assessed qualitatively. Surgery was successful in all patients. Subluxation was noninferior to divide-and-conquer in ECL. Effective phaco times were similar, but subluxation associated with shorter procedure duration. CONCLUSIONS: The subluxation technique was noninferior to divide-and-conquer regarding postoperative ECL, at least in the first 3 months, and associated with reduced intervention time. Subluxation techniques may be suitable alternatives to endocapsular techniques.Clinical Trial Registration-URL: ClinicalTrials.gov. Unique identifier: NCT02535819.
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Facoemulsificação , Idoso , Perda de Células Endoteliais da Córnea/diagnóstico , Endotélio Corneano , Feminino , Humanos , Masculino , Facoemulsificação/métodos , Estudos Prospectivos , Método Simples-Cego , Acuidade VisualRESUMO
BACKGROUND: Coronary angiography is the gold standard for the diagnosis of coronary artery disease. This intervention is nevertheless a source of anxiety for the patient both by its discomfort and by the consequences linked to the discovery of potential diseases. OBJECTIVES: The aim of this study was to determine the effectiveness of hypnosis in reducing anxiety in patients undergoing coronary angiography. METHODS: One hundred sixty-nine patients with planned coronary angiography and no history of coronary angiography were randomized to a hypnosis or control group. Patients in the hypnosis group underwent a hypnosis session with self-hypnosis posthypnotic suggestions, while those in the control group had a conversational interview with the hypnotherapist. The primary endpoint was pre-exam anxiety level assessed by the Spielberger State-Trait Anxiety Inventory (STAI-Y A). RESULTS: Performing a hypnosis session did not result in a significant decrease in anxiety before the intervention. Age, high trait anxiety, high state anxiety the day before, and belief that hypnosis works in general were associated with increased anxiety before the procedure. No adverse events were reported after hypnosis. There was no statistically significant difference between the 2 groups for the occurrence of complications of the intervention. CONCLUSION: In this study, performing a hypnosis session before coronary angiography did not reduce the state of anxiety measured just before the intervention. In all cases, the hypnotic experience appears to be positive for the patient, encouraging further research efforts. TRIAL REGISTRATION: The research protocol has been registered on the ClinicalTrials.gov registry (NCT02818101; 29/06/2016) and with the ANSM (IDRCB 2016-A00205-46; 02/02/2016).
Assuntos
Transtornos de Ansiedade , Hipnose , Humanos , Estudos Prospectivos , Ansiedade/prevenção & controle , AngiografiaRESUMO
PURPOSE: This retrospective cohort study assessed the evolution of corneal transplantation and its indications in the last 21 years (2000-2020) in a specialized ophthalmology department in a tertiary referral center in France. METHODS: The surgical techniques and indications, patient age and sex, and postoperative best-corrected visual acuity (BCVA) 6 months after keratoplasty were extracted. RESULTS: In total, 1042 eyes underwent keratoplasty in 2000-2020. Annual numbers of corneal transplantations increased by 2.2-fold. Penetrating keratoplasty (PKP) was the sole technique for the first 11 years. Descemet stripping automated endothelial keratoplasty (DSAEK) and Descemet membrane endothelial keratoplasty (DMEK) were introduced in 2011 and 2014, respectively. Cases of both quickly increased, accounting for 28% and 41% of cases in 2015-2020, respectively. Eventually, DSAEK and DMEK were respectively used for most pseudophakic bullous keratopathy (PBK) and all Fuchs endothelial cell dystrophy (FECD) cases. PKP cases declined to 27%. Deep anterior lamellar keratoplasty (DALK) was rare (3% of all cases). These changes associated with rises in PBK and particularly FECD cases, and a strong decline in keratoconus, causing FECD, PBK, and keratoconus to move from being the 4th, 1st, and 3rd most common indications to the 1st, 2nd, and 6th, respectively. On average, BCVA improved by 0.1-0.3 logMAR. Patient age dropped steadily over time. Female predominance was observed. CONCLUSIONS: The invention of DSAEK and then DMEK precipitated an enormous change in clinical practice and a large expansion of keratoplasty to new indications. This study confirms and extends previous findings in other countries.
Assuntos
Ceratoplastia Endotelial com Remoção da Lâmina Limitante Posterior , Distrofia Endotelial de Fuchs , Ceratocone , Ceratoplastia Endotelial com Remoção da Lâmina Limitante Posterior/métodos , Feminino , Distrofia Endotelial de Fuchs/cirurgia , Humanos , Ceratoplastia Penetrante/métodos , Masculino , Estudos RetrospectivosRESUMO
(1) Backround: Technological advances should foster gains in physicians' efficiency. For example, a reduction of the medical decision time can be enabled by faster biological tests. The main objective of this study was to collect responses from an international panel of physicians on their needs for biomarkers and also to convey the improvement in the outcome to be made possible by the potential development of fast diagnostic tests for these biomarkers. (2) Methods: we distributed a questionnaire on the Internet to physicians. (3) Results: 508 physicians participated in this survey. The mean age was 38 years. General practice and emergency medicine were heavily represented, with 95% CIs of 44% (39.78, 48.41) and 32% (27.84, 35.94)), respectively. The two most represented countries were France (95% CI: 74% (70.20, 77.83)) and the USA (95% CI: 11% (8.65, 14.18)). Ninety-eight percentages of the physicians thought that obtaining cited biomarkers more quickly would be beneficial to their practice and to patient's care. The main biomarkers of interest identified by our panel were troponin (95% CI: 51% (46.24, 54.94)), C-reactive protein (95% CI: 42% (38.03, 46.62)), D-dimer (95% CI: 29% (24.80, 32.68)), and brain natriuretic peptide (95% CI: 13% (10.25, 16.13)). (4) Conclusions: Our study highlights the real technological need for fast biomarker results, which could be provided by biosensors. The relevance of some answers such as troponin is questionable.