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The laryngeal mask airway (LMA) is commonly used for airway management. Cuff hyperinflation has been associated with complications, poor ventilation and increased risk of gastric insufflation. This study was designed to determine the best cuff inflation method of AuraOnce™ LMA during bronchoscopy and EBUS (Endobronquial Ultrasound Bronchoscopy) procedure. We designed a Randomized controlled, doble-blind, clinical trial to compare the efficacy and safety of three cuff inflation methods of AuraOnce™ LMA. 210 consenting patients scheduled for EBUS procedure under general anesthesia, using AuraOnce™ LMA were randomized into three groups depending on cuff insufflation: residual volume (RV), half of the maximum volume (MV), unchanged volume (NV). Parameters regarding intracuff pressure (IP), airway leak pressure (OLP), leakage volume (LV) were assessed, as well as postoperative complications (PC). 201 (95.7%) patients completed the study. Mean IP differed between groups (MV: 59.4 ± 32.4 cm H2O; RV: 75.1 ± 21.1 cm H2O; NV: 83.1 ± 25.5 cmH20; P < 0.01). The incidence of IP > 60 cmH2O was lower in the MV group compared to the other two (MV: 20/65(30.8%); RV:47/69 (68.1%); NV 48/67 (71.6%); p < 0.01). The insertion success rate was 89,6% (180/201) at first attempt, with no difference between groups (p = 0.38). No difference between groups was found either for OLP (p = 0.53), LV (p = 0.26) and PC (p = 0.16). When a cuff manometer is not available, a partial inflation of AuraOnce™ LMA cuff using MV method allows to control intracuff pressure, with no significant changes of OLP and LV compared to RV and NV insufflation method.Registration clinical trial: NCT04769791.
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Insuflación , Máscaras Laríngeas , Humanos , Máscaras Laríngeas/efectos adversos , Insuflación/efectos adversos , Anestesia General/métodos , Complicaciones Posoperatorias/etiología , Manejo de la Vía Aérea/efectos adversosRESUMEN
Dieulafoy's lesion (DL) is an uncommon vascular malformation-an aberrant, dilated submucosal arteriole (1-3 mm thick, 10 x nv). It runs near the mucosal surface and protrudes, and may potentially induce gastrointestinal bleeding (GIB). It usually originates in the stomach (upper lesser curvature), with endoscopy being the diagnostic, therapeutic modality of choice. Jejunal DL (JDL) is a rare cause of obscure GIB (OGIB) that is challenging for endoscopists and threatens patient lives. Other diagnostic techniques such as Tc99m-labeled red blood cell scintigraphy, well established in the classic armamentarium for OGIB diagnosis, cannot overcome endoscopic procedures. We report the case of a patient with OGIB secondary to an exceptionally located Dieulafoy's lesion who underwent combined endoscopic treatment.
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Endoscopic retrograde cholangio-pancreatography (ERCP) is a diagnostic, therapeutic technique for the management of pancreato-biliary conditions. Technical contraindications include the presence of intraluminal foreign bodies precluding endoscope passage. Intragastric balloon (IGB) is a bariatric procedure that provides sensations of early fullness and satiety from intragastric occupation, thus leading to weight loss. While, according to guidelines, choledocholithiasis and cholangitis do not represent an indication for IGB removal in contrast to moderate-severe pancreatitis, where need for an ERCP and the procedure's technical difficulty most commonly require it. We report the case of a female patient with an IGB where ERCP was indicated. CASE REPORT: A 47-year-old woman visited the emergency room for epigastric abdominal pain radiating to her back. She had jaundice without pyrexic symptoms. At the ER an ultrasonogram revealed cholelithiasis and a dilated common bile duct (11 mm in diameter), no cause being then identified. Lab tests rule out pancreatic involvement and associated infection. The patient had an IGB (Photo 1a) implanted 5 months before the present episode. She was admitted to the gastroenterology ward with choledocholithiasis as suspected diagnosis. The study was completed by endoscopic ultrasound (EUS), which confirmed a dilated hepatocholedochal duct at 15.3 mm in diameter (Photo 1b), secondary to multiple choledochal stones. A direct ERCP procedure was initiated where the IGB precluded rectification and proper placement, which forced the use of a double-guidewire technique for cannulation (Photo 1c)5. Sphincterotomy and sphincteroplasty to 10 mm ensued, and 8 stones were removed using a balloon and then a basket catheter (Photo 1d). The patient was discharged at 24 hours after the procedure with no complications. DISCUSSION: No prior studies are available that describe the possibility of therapeutic ERCP for choledocholithiasis in IGB-carrying patients; in most cases IGB removal is taken for granted because of the procedure's technical difficulty. Our case report may well show a safe alternative to IGB removal by using less conventional cannulation techniques without higher complication rates. However, further cases are needed in order to draw significant conclusions regarding their widespread use.
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Colonic lymphoma involving the mucosa-associated lymphoid tissue (MALT) is an uncommon pathology, with an unknown pathogenesis and varied endoscopic appearance. We present the case of a 78-year-old female with challenging endoscopic findings that resulted in the diagnosis of a colonic MALT lymphoma.
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Neoplasias del Colon , Linfoma de Células B de la Zona Marginal , Femenino , Humanos , Anciano , Linfoma de Células B de la Zona Marginal/diagnóstico por imagen , Linfoma de Células B de la Zona Marginal/cirugía , Endoscopía , Neoplasias del Colon/diagnóstico por imagen , Neoplasias del Colon/cirugía , Neoplasias del Colon/patologíaRESUMEN
Endoscopic retrograde cholangiopancreatography (ERCP) is one of the most frequently performed procedures in the treatment of biliary-pancreatic diseases. Hematoma after ERCP is an infrequent and highly serious complication. We present three cases with hepatic hematoma after a CPRE.
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Sistema Biliar , Enfermedades de la Vesícula Biliar , Hepatopatías , Enfermedades Pancreáticas , Humanos , Colangiopancreatografia Retrógrada Endoscópica/efectos adversos , Colangiopancreatografia Retrógrada Endoscópica/métodos , Hepatopatías/etiología , Enfermedades Pancreáticas/complicaciones , Hematoma/diagnóstico por imagen , Hematoma/etiologíaRESUMEN
Obesity represents a significant global health problem, and reducing its alarmingly high incidence is an urgent challenge. The intragastric balloon is a safe and effective device for weight loss; therefore, it is widely used. Although the frequency of serious complications resulting from its use is low, it is not exempt from them. We would like to present a case of a severe but infrequent complication secondary to this device, with the aim of highlighting the most appropriate procedure in such cases and emphasizing the importance of awareness regarding it.
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BACKGROUND: intragastric balloons (IGBs) are a minimally invasive, increasingly popular option for obesity treatment. However, there is only one worldwide guideline standardizing the technical aspects of the procedure (BIBC, SOARD 2018). OBJECTIVES: to construct a practical guideline for IGB usage by reproducing and expanding the BIBC survey among the Spanish Bariatric Endoscopy Group (GETTEMO). METHODS: a 140-question survey was submitted to all GETTEMO members. Twenty-one Spanish experienced endoscopists in IGBs answered back. Eight topics on patient selection, indications/contraindications, technique, multidisciplinary follow-up, results, safety, and financial/legal aspects were discussed. Consensus was defined as consensus ≥ 70 %. RESULTS: overall data included 20 680 IGBs including 12 different models. Mean age was 42.0 years-old, 79.9 % were women, and the mean preoperative body mass index (BMI) was 34.05 kg/m². Indication in BMI > 25 kg/m², 10 absolute contraindications, and nutritional and medication measures at follow-up were settled. A mean %TBWL (total body weight loss) of 17.66 % ± 2.5 % was observed. Early removal rate due to intolerance was 3.62 %. Adverse event rate was 0.70 % and 6.37 % for major and minor complications with consensual management. A single case of mortality occurred. IGBs were placed in private health, prior contract, and with full and single payment at the beginning. Seven lawsuits (0.034 %) were received, all ran through civil proceeding, and with favorable final resolution. CONCLUSIONS: this consensus based on more than 20 000 cases represents practical recommendations to perform IGB procedures. This experience shows that the device leads to satisfactory weight loss with a low rate of adverse events. Most results are reproducible compared to those obtained by the BIBC.
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Balón Gástrico , Obesidad Mórbida , Humanos , Femenino , Adulto , Masculino , Balón Gástrico/efectos adversos , Endoscopía Gastrointestinal , Consenso , Pérdida de Peso , Índice de Masa Corporal , Obesidad Mórbida/cirugía , Resultado del TratamientoRESUMEN
Primary intestinal lymphangiectasia is a rare disorder associated with protein-losing enteropathy. The main manifestations are those resulting from hypoalbuminemia. Diagnosis requires the typical endoscopic image of intestinal lymphangiectasia and increased 24-hour fecal alpha-1-antitrypsin clearance. Treatment is basically dietary.
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Linfangiectasia Intestinal , Enteropatías Perdedoras de Proteínas , Humanos , Enteropatías Perdedoras de Proteínas/etiología , Enfermedades Raras , Linfangiectasia Intestinal/complicaciones , DietaRESUMEN
AIM: Although circulatory impairment during the transitional circulation associates morbidity and mortality, its treatment remains controversial. In a pilot trial on circulatory impairment defined as low superior vena cava (SVC) flow, dobutamine (Db) versus placebo (PL) showed a trend towards improved short-term outcomes. The purpose of this study was to report on the long-term outcome of the infants who were observed for SVC flow patterns. METHODS: Among the 126 infants <31 weeks of gestation prospectively scanned from birth, 28 presented low SVC flow within the first 24 h after birth and received Db (n = 16) or PL (n = 12). Follow-up of survivors included motor assessment and Bayley Scales II or III at 2 years, and the Reynolds Intellectual Assessment Scale at 6 years. Neurodevelopmental impairment (NDI) was defined as: cerebral palsy (Gross Motor Function Classification System ≥ level 2), or a cognitive function score < -2 standard deviations; or moderate or severe hearing or visual impairment. Db group, PL group and normal-flow group were compared. RESULTS: Eighteen infants died (Db: 5; PL: 2; normal flow group: 11, P = 0.1). Follow-up in survivors was accomplished in 80% and 55% of the cohort at 2 years and 6 years, respectively. No significant difference in the combined outcome (mortality or NDI) was found between the groups (42% Db, 36% PL, 30% normal flow group). CONCLUSIONS: This exploratory analysis did not show any differences in the long-term outcome of infants according to SVC flow patterns or its treatment early after birth.
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Parálisis Cerebral , Dobutamina , Estudios de Cohortes , Dobutamina/uso terapéutico , Humanos , Lactante , Recién Nacido , Recien Nacido Prematuro , Vena Cava Superior/diagnóstico por imagenRESUMEN
Ring avulsions continue to be a challenge in reconstructive surgery. We conducted a retrospective study and reviewed all Urbaniak-Kay type IV degloving injuries replanted at our institution between 2011 and 2018. A systematic review of the literature was also conducted to assess the survival rates, functional, and sensibility outcomes. The results of our systematic review outline a survival rate of 79.50% (101/127). With 1 artery being repaired, 79% of the fingers survived, a value that increased to 87.50% when 2 arteries were anastomosed (P = 0.484). Statistically significant differences (P < 0.001) were found when comparing the survival rates of the fingers with 2 or more veins repaired (87%) with those with only 1 vein anastomosed (51.90%). In terms of nerve reconstruction, there was a significant difference (P < 0.001) with the 2-point discrimination test in favor of the reconstructed group when nerve reparation was done (10.80 mm ± 2.95 mm) versus when digital nerves were not repaired (15.25 mm ± 0.50 mm). Fingers after secondary procedures did not obtain better mobility. The mean total active motion in nonreoperated fingers was 221 degrees (195-270 degrees), whereas the total active motion in the cases who received secondary surgeries was 152 degrees (110-195 degrees), with statistically significant differences (P = 0.02). Therefore, we recommend attempting replantation of degloved fingers. All efforts must be done to carry out 2 vein anastomoses, and our results strongly recommend attempting at least some kind of nerve reconstruction. Secondary surgeries should be reserved for selected cases only, because of the extensive scarring in this kind of injuries. Early mobilization protocols must be encouraged to achieve a good functional result.
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Amputación Traumática , Traumatismos de los Dedos , Procedimientos de Cirugía Plástica , Amputación Traumática/cirugía , Traumatismos de los Dedos/cirugía , Dedos/cirugía , Humanos , Reimplantación , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: endoscopic retrograde cholangiopancreatography (ERCP) in patients with Roux-en-Y anatomy is challenging. Single-balloon enteroscopy-assisted ERCP (SBE-ERCP) is an innovative alternative to reach the bile duct. OBJECTIVE: to report our experience in SBE-ERCP in patients who presented with Roux-en-Y anatomy and choledocholithiasis. PATIENTS AND METHODS: patients who presented choledocholithiasis and underwent SBE-ERCP between January 2018 and April 2020 were retrospectively identified via medical records and the digestive endoscopy database. Enteroscopy success was defined as reaching the biliary limb and papilla identification. ERCP diagnostic success was defined as a successful duct cannulation and cholangiography, and ERCP procedural success was defined as the ability to successfully carry out choledocholithiasis extraction. Complications of ERCP were defined according to standard criteria. RESULTS: a total of eleven patients (two females) with a mean age of 81 years (range 60-91 years) with Roux-en-Y anastomosis underwent ERCP using a SBE on 13 occasions. The indication for all procedures was choledocholithiasis, which had been previously confirmed by magnetic resonance cholangiopancreatography (MRCP). Enteroscopy success occurred in 13/13 (100 %) of procedures. Overall ERCP diagnostic success was achieved in 11/13 (84.6 %) of procedures. The ERCP procedural success was obtained in 11/11 (100 %) of patients (84.6 % of procedures). A mild pancreatitis occurred in a patient with native papilla. CONCLUSIONS: SBE-ERCP is feasible, efficacious and safe in patients with postsurgical Roux-en-Y anatomy and choledocholithiasis. Technical improvements may mean better outcomes.
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Coledocolitiasis , Enteroscopia de Balón Individual , Anciano , Anciano de 80 o más Años , Anastomosis en-Y de Roux , Colangiopancreatografia Retrógrada Endoscópica , Coledocolitiasis/diagnóstico por imagen , Coledocolitiasis/cirugía , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios RetrospectivosRESUMEN
BACKGROUND: The best technique to identify the epidural space for labor analgesia is still unclear despite the publication of various randomized controlled studies and meta-analyses. Our aim was to assess the superiority of the saline loss of resistance (SLOR) technique over the air loss of resistance (ALOR) technique with respect to the quality of the block. METHODS: Consenting parturients admitted to our obstetric suite for spontaneous or induced labor were randomized to receive epidural analgesia using either the ALOR or SLOR technique. Our primary outcome was to compare the impact of the SLOR and ALOR technique on pain score improvement measured 30 minutes after administration of epidural block. Our secondary outcomes included the density of motor blockade and analgesic efficacy measured at 30 minutes. Primary and secondary outcomes were compared using the Student t test and Mann-Whitney U test. Statistical significance was set at P < .017 for primary and secondary outcomes, considering Bonferroni correction for multiple comparisons. Other comparisons were considered exploratory. RESULTS: Four hundred parturients were included; 24 were excluded from the final analysis. After 30 minutes, pain score reduction (ALOR, 4.7 ± 2.9/10; SLOR, 4.9 ± 3.0/10; P = .49), motor block (ALOR, 1.4 ± 0.8; SLOR, 1.3 ± 0.8; P = .27), and efficacy of the block (ALOR, 1.0 ± 0.7; SLOR, 1.0 ± 0.6; P = .87) did not differ significantly between groups. CONCLUSIONS: Pain score reduction after 30 minutes and onset of the block were not affected by the technique used to locate the epidural space.
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Aire , Analgesia Epidural/métodos , Espacio Epidural/efectos de los fármacos , Trabajo de Parto/efectos de los fármacos , Solución Salina/administración & dosificación , Adulto , Analgesia Epidural/tendencias , Método Doble Ciego , Espacio Epidural/fisiología , Femenino , Humanos , Trabajo de Parto/fisiología , Dimensión del Dolor/efectos de los fármacos , Dimensión del Dolor/métodos , Embarazo , Estudios ProspectivosRESUMEN
Nowadays, some endoscopists believe that knowing a patient has common bile duct stones (CBDS) is not enough. An added value is required that allows the endoscopist performing the endoscopic retrograde cholangiopancreatography (ERCP) to obtain accurate and useful information in order to offer the best management of the condition. The added value of magnetic resonance cholangiopancreatography (MRCP) is attractive and can contribute to the success of the procedure.
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Colangiopancreatografia Retrógrada Endoscópica/métodos , Pancreatocolangiografía por Resonancia Magnética/métodos , Cálculos Biliares/diagnóstico por imagen , Cálculos Biliares/terapia , HumanosRESUMEN
Prochlorococcus is responsible for a significant part of CO2 fixation in the ocean. Although it was long considered an autotrophic cyanobacterium, the uptake of organic compounds has been reported, assuming they were sources of limited biogenic elements. We have shown in laboratory experiments that Prochlorococcus can take up glucose. However, the mechanisms of glucose uptake and its occurrence in the ocean have not been shown. Here, we report that the gene Pro1404 confers capability for glucose uptake in Prochlorococcus marinus SS120. We used a cyanobacterium unable to take up glucose to engineer strains that express the Pro1404 gene. These recombinant strains were capable of specific glucose uptake over a wide range of glucose concentrations, showing multiphasic transport kinetics. The Ks constant of the high affinity phase was in the nanomolar range, consistent with the average concentration of glucose in the ocean. Furthermore, we were able to observe glucose uptake by Prochlorococcus in the central Atlantic Ocean, where glucose concentrations were 0.5-2.7 nM. Our results suggest that Prochlorococcus are primary producers capable of tuning their metabolism to energetically benefit from environmental conditions, taking up not only organic compounds with key limiting elements in the ocean, but also molecules devoid of such elements, like glucose.
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Proteínas Bacterianas/metabolismo , Proteínas Facilitadoras del Transporte de la Glucosa/metabolismo , Glucosa/metabolismo , Océanos y Mares , Prochlorococcus/metabolismo , Microbiología del Agua , Proteínas Bacterianas/genética , Transporte Biológico Activo/fisiología , Proteínas Facilitadoras del Transporte de la Glucosa/genética , Prochlorococcus/genéticaRESUMEN
Autologous flap breast reconstruction is an established technique that carries a risk of vascular failure. We evaluated the safety of salvaging impending venous congestion by using the cephalic vein for supercharging autologous abdominal flaps. Our main outcome measures were flap survival, triggering or impairing lymphedema as measured by the physician or reported by the patient, and scar severity as measured by the Vancouver scar scale. We were able to save 100% of the flaps, but could not find any statistical association with or without increased lymphedema before and after the procedure. One patient reported that lymphedema worsened. The patients accepted the scars (mean Vancouver scar scale score, 5.7). In sum, using the cephalic vein to improve venous drainage of autologous breast reconstruction was safe and did not trigger or impair lymphedema, but scarring in the upper arm was unavoidable.
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Brazo/irrigación sanguínea , Hiperemia/cirugía , Mamoplastia/métodos , Complicaciones Posoperatorias/cirugía , Terapia Recuperativa/métodos , Colgajos Quirúrgicos/irrigación sanguínea , Anciano , Cicatriz/etiología , Cicatriz/prevención & control , Femenino , Estudios de Seguimiento , Supervivencia de Injerto , Humanos , Hiperemia/etiología , Linfedema/etiología , Linfedema/prevención & control , Persona de Mediana Edad , Complicaciones Posoperatorias/prevención & control , Estudios Prospectivos , Colgajos Quirúrgicos/cirugía , Resultado del Tratamiento , Venas/trasplanteRESUMEN
OBJECTIVES: The management of renal trauma has undergone important changes in recent years, the current tendency being more conservative than in the past. The present study analyzes our experience over the last 11 years in patients with isolated renal trauma or associated to other lesions. METHODS: Over an 11-year period (January 2001- December 2011 ) we documented a total of 149 renal injuries (47 isolated and 102 associated renal lesions ). An analysis was made of the demographic characteristics of the two groups, as well as of the clinical presentation, diagnostic methods, grade of injury, associated lesions, emergency management, mortality, and length of stay. RESULTS: Closed trauma secondary to fall was the most frequent type of injury in both groups. The grade of injury proved similar in both (80%corresponding to grades 1-3 and 20% to grades 4-5). Conservative management was used in 93% of all isolated renal injuries and in 75.5% of the polytrauma patients with 10% and 5.7% failure rates respectively. Mortality rates were 0% and 7.8%, respectively. CONCLUSIONS: Renal injures are increasingly subjected to conservative management, with treatment generally being somewhat more aggressive in polytrauma patients.
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Riñón/lesiones , Traumatismo Múltiple/complicaciones , Traumatismo Múltiple/terapia , Adolescente , Adulto , Anciano , Femenino , Humanos , Incidencia , Riñón/cirugía , Masculino , Persona de Mediana Edad , Traumatismo Múltiple/epidemiología , Estudios Retrospectivos , Adulto JovenRESUMEN
Cyanobacteria evolved the oxygenic photosynthesis to generate organic matter from CO2 and sunlight, and they were responsible for the production of oxygen in the Earth's atmosphere. This made them a model for photosynthetic organisms, since they are easier to study than higher plants. Early studies suggested that only a minority among cyanobacteria might assimilate organic compounds, being considered mostly autotrophic for decades. However, compelling evidence from marine and freshwater cyanobacteria, including toxic strains, in the laboratory and in the field, has been obtained in the last decades: by using physiological and omics approaches, mixotrophy has been found to be a more widespread feature than initially believed. Furthermore, dominant clades of marine cyanobacteria can take up organic compounds, and mixotrophy is critical for their survival in deep waters with very low light. Hence, mixotrophy seems to be an essential trait in the metabolism of most cyanobacteria, which can be exploited for biotechnological purposes.
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Cianobacterias , Cianobacterias/genética , Cianobacterias/metabolismo , Fotosíntesis/fisiología , Atmósfera , Oxígeno/metabolismoRESUMEN
Microbial associations and interactions drive and regulate nutrient fluxes in the ocean. However, physical contact between cells of marine cyanobacteria has not been studied thus far. Here, we show a mechanism of direct interaction between the marine cyanobacteria Prochlorococcus and Synechococcus, the intercellular membrane nanotubes. We present evidence of inter- and intra-genus exchange of cytoplasmic material between neighboring and distant cells of cyanobacteria mediated by nanotubes. We visualized and measured these structures in xenic and axenic cultures and in natural samples. We show that nanotubes are produced between living cells, suggesting that this is a relevant system of exchange material in vivo. The discovery of nanotubes acting as exchange bridges in the most abundant photosynthetic organisms in the ocean may have important implications for their interactions with other organisms and their population dynamics.
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Nanotubos , Prochlorococcus , Synechococcus , Synechococcus/metabolismo , Nanotubos/química , Prochlorococcus/metabolismo , Cianobacterias/metabolismo , Organismos Acuáticos , Agua de Mar/microbiologíaRESUMEN
Understanding the atmospheric processes involving carbonaceous aerosols (CAs) is crucial for assessing air pollution impacts on human health and climate. The sources and formation mechanisms of CAs are not well understood, making it challenging to quantify impacts in models. Studies suggest residential wood combustion (RWC) and traffic significantly contribute to CAs in Europe's urban and rural areas. Here, we used an atmospheric chemistry model (MONARCH) and three different emission inventories (two versions of the European-scale emission inventory CAMS-REG_v4 and the HERMESv3 detailed national inventory for Spain) to assess the uncertainties in CAs simulation and source allocation (from traffic, RWC, shipping, fires and others) in Northeast Spain. For this, black carbon (BC) and organic aerosol (OA) measurements performed at three supersites representing different environments (urban, regional and remote) were used. Our findings show the importance of model resolution and detailed emission input data in accurately reproducing BC/OA observations. Even though emissions of total particulate matter are rather consistent between inventories in Spain, we found discrepancies between them mainly related to the spatiotemporal disaggregation (particularly relevant for traffic and RWC) and the treatment of the condensable fraction of CAs in RWC (changes in the speciation of elemental/organic carbon). The main source contribution to BC concentrations in the urban site is traffic, accounting for 71.1%/65.2% (January/July) in close agreement with the fossil contribution derived from observations (78.8%/84.2%), followed by RWC (12.8%/3%) and shipping emissions (5.4%/13.8%). An over-representation of RWC (winter) and shipping (summer) is obtained with CAMS-REG_v4. Noteworthy uncertainties arise in OA results due to condensables in emissions and a limited secondary aerosol production in the model. These findings offer insights into MONARCH's effectiveness in simulating CAs concentrations and source contribution in Northeast Spain. The study highlights the benefits of combining new datasets and modeling techniques to refine emission inventories and better understand and mitigate air pollution impacts.
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Contaminantes Atmosféricos , Humanos , Contaminantes Atmosféricos/análisis , Monitoreo del Ambiente/métodos , Material Particulado/análisis , Carbono/análisis , Aerosoles/análisis , Región MediterráneaRESUMEN
INTRODUCTION: Intragastric balloon (IGB) is a minimally invasive and reversible option for obesity treatment. There is a worldwide growing number of different IGB models. The efficacy and safety profile for each model must be demonstrated. We aim to evaluate IGB safety profile according to the experience of the Spanish Bariatric Endoscopy Group (GETTEMO). METHODS: A survey of 37 IGBs safety-related questions was sent to all GETTEMO members, to retrospectively collect a multicenter Spanish registry. Incidence, causes, and resolution of both major and minor complications and adverse events (AEs), including legal consequences, differentiated for each balloon model were evaluated. Secondary outcome was weight loss data to confirm efficacy. RESULTS: Twenty-one Spanish hospitals experienced in IGBs responded. The overall data encompassed 20,680 IGBs, including 12 different models. Mean %TBWL of 17.66 ± 2.5% was observed. Early removal rate due to intolerance was 3.62%. Mean major complications rate was 0.70% (> 1% in Spatz2, HB, and Spatz3 models), mainly complicated gastric ulcer. Minor AEs rate was 6.37%, mainly esophagitis. Nine cases (0.04%) required surgery. A single case of mortality (0.0048%) occurred. Seven lawsuits (0.0034%) were received, all with favorable resolution. CONCLUSIONS: In the Spanish experience accumulating 20,680 IGBs and including 12 different balloon models, a low incidence rate of major complications and minor AEs are observed (0.70% and 6.37%, respectively), mostly resolved with medical/endoscopic management. IGB shows good tolerance and efficacy profile. These safety data are within the accepted quality standards.