Effect of high versus low dose of dexamethasone on clinical worsening in patients hospitalised with moderate or severe COVID-19 pneumonia: an open-label, randomised clinical trial.

BACKGROUND: Low-dose dexamethasone demonstrated clinical improvement in patients with coronavirus disease 2019 (COVID-19) needing oxygen therapy; however, evidence on the efficacy of high-dose dexamethasone is limited. METHODS: We performed a randomised, open-label, controlled trial involving hospitalised patients with confirmed COVID-19 pneumonia needing oxygen therapy. Patients were randomly assigned in a 1:1 ratio to receive low-dose dexamethasone (6 mg once daily for 10 days) or high-dose dexamethasone (20 mg once daily for 5 days, followed by 10 mg once daily for an additional 5 days). The primary outcome was clinical worsening within 11 days since randomisation. Secondary outcomes included 28-day mortality, time to recovery and clinical status at day 5, 11, 14 and 28 on an ordinal scale ranging from 1 (discharged) to 7 (death). RESULTS: A total of 200 patients (mean±sd age 64±14 years; 62% male) were enrolled. 32 (31.4%) out of 102 patients enrolled in the low-dose group and 16 (16.3%) out of 98 in the high-dose group showed clinical worsening within 11 days since randomisation (rate ratio 0.427, 95% CI 0.216-0.842; p=0.014). The 28-day mortality was 5.9% in the low-dose group and 6.1% in the high-dose group (p=0.844). There was no significant difference in time to recovery, and in the seven-point ordinal scale at days 5, 11, 14 and 28. CONCLUSIONS: Among hospitalised COVID-19 patients needing oxygen therapy, high dose of dexamethasone reduced clinical worsening within 11 days after randomisation, compared with low dose.

Documento de consenso de la Sociedad Española de Medicina Intensiva, Crítica, y Unidades Coronarias (SEMICYUC), la Sociedad Española de Otorrinolaringología y Cirugía de Cabeza y Cuello (SEORL-CCC) y la Sociedad Española de Anestesiología y Reanimación (SEDAR) sobre la traqueotomía en pacientes con COVID-19 / Consensus documentof the Spanish Society of Intensive and Critical Care Medicine and Coronary Units (SEMICYUC), the Spanish Society of Otorhinolaryngology and Head and Neck Surgery (SEORL-CCC) and the Spanish Society of Anesthesiology and Resuscitation (SEDAR) on tracheotomy in patients with COVID-19 infection

La alta incidencia de insuficiencia respiratoria aguda en el contexto de la pandemia por COVID-19 ha conllevado el uso de ventilación mecánica hasta en un 15%. Dado que la traqueotomía es un procedimiento quirúrgico frecuente, este documento de consenso, elaborado por tres Sociedades Científicas, la SEMICYUC, la SEDAR y la SEORL-CCC, tiene como objetivo ofrecer una revisión de las indicaciones y contraindicaciones de traqueotomía, ya sea por punción o abierta, esclarecer las posibles ventajas y exponer las condiciones ideales en que deben realizarse y los pasos que considerar en su ejecución. Se abordan situaciones regladas y urgentes, así como los cuidados posoperatorios

The current COVID-19 pandemic has rendered up to 15% of patients under mechanical ventilation. Because the subsequent tracheotomy is a frequent procedure,the three societies mostly involved (SEMICYUC, SEDAR and SEORL-CCC) have setup a consensus paper that offers an overview about indications and contraindications of tracheotomy, be it by puncture or open, clarifying its respective advantages and enumerating the ideal conditions under which they should be performed, as well as the necessary steps. Regular and emergency situations are displayed together with the postoperative measures

Development and validation of a clinical score to estimate progression to severe or critical state in COVID-19 pneumonia hospitalized patients.

The prognosis of a patient with COVID-19 pneumonia is uncertain. Our objective was to establish a predictive model of disease progression to facilitate early decision-making. A retrospective study was performed of patients admitted with COVID-19 pneumonia, classified as severe (admission to the intensive care unit, mechanic invasive ventilation, or death) or non-severe. A predictive model based on clinical, laboratory, and radiological parameters was built. The probability of progression to severe disease was estimated by logistic regression analysis. Calibration and discrimination (receiver operating characteristics curves and AUC) were assessed to determine model performance. During the study period 1152 patients presented with SARS-CoV-2 infection, of whom 229 (19.9%) were admitted for pneumonia. During hospitalization, 51 (22.3%) progressed to severe disease, of whom 26 required ICU care (11.4); 17 (7.4%) underwent invasive mechanical ventilation, and 32 (14%) died of any cause. Five predictors determined within 24 h of admission were identified: Diabetes, Age, Lymphocyte count, SaO2, and pH (DALSH score). The prediction model showed a good clinical performance, including discrimination (AUC 0.87 CI 0.81, 0.92) and calibration (Brier score = 0.11). In total, 0%, 12%, and 50% of patients with severity risk scores ≤ 5%, 6-25%, and > 25% exhibited disease progression, respectively. A risk score based on five factors predicts disease progression and facilitates early decision-making according to prognosis.

Documento de consenso de la Sociedad Española de Medicina Intensiva, Crítica, y Unidades Coronarias (SEMICYUC), la Sociedad Española de Otorrinolaringología y Cirugía de Cabeza y Cuello (SEORL-CCC) y la Sociedad Española de Anestesiología y Reanimación (SEDAR) sobre la traqueotomía en pacientes con COVID-19 / Consensus document of the Spanish Society of Intensive and Critical Care Medicine and Coronary Units (SEMICYUC), the Spanish Society of Otorhinolaryngology and Head and Neck Surgery (SEORL-CCC) and the Spanish Society of Anesthesiology and Resuscitation (SEDAR) on tracheotomy in patients with COVID-19 infection

La alta incidencia de insuficiencia respiratoria aguda en el contexto de la pandemia por COVID-19 ha conllevado el uso de ventilación mecánica hasta en un 15%. Dado que la traqueotomía es un procedimiento quirúrgico frecuente, este documento de consenso, elaborado por tres Sociedades Científicas, la SEMICYUC, la SEDAR y la SEORL-CCC, tiene como objetivo ofrecer una revisión de las indicaciones y contraindicaciones de traqueotomía, ya sea por punción o abierta, esclarecer las posibles ventajas y exponer las condiciones ideales en que deben realizarse y los pasos que considerar en su ejecución. Se abordan situaciones regladas y urgentes, así como los cuidados posoperatorios

The current COVID-19 pandemic has rendered up to 15% of patients under mechanical ventilation. Because the subsequent tracheotomy is a frequent procedure,the three societies mostly involved (SEMICYUC, SEDAR and SEORL-CCC) have setup a consensus paper that offers an overview about indications and contraindications of tracheotomy, be it by puncture or open, clarifying its respective advantages and enumerating the ideal conditions under which they should be performed, as well as the necessary steps. Regularand emergency situations are displayed together with the postoperative measures

Microscopic Study of Injectable Steroids: Effects of Postmixing Time on Particle Aggregation.

BACKGROUND: Epidural steroid injection (ESI) is a common practice for pain treatment since 1953. In 2014, the FDA issued a warning about ESI. Studies have focused on the effect of the particle size and their ability to generate harmful aggregates. Although steroid aggregates provide longer times for reabsorption, therefore a longer anti-inflammatory effect, they are potentially harmful to the central nervous system via embolic mechanisms.Previous studies have established that steroidal aggregates with asizes over 100 mu m are potentially able to occlude blood vessels. Studies by Tiso et al and Benzon et al addressed the role of steroids on CNS adverse events, with similar outcomes. The main difference was on the role of aggregates with a size over 100 mu m, which Benzon et al. attributed to the ability of certain steroid preparations to rapidly precipitate and form large aggregates. OBJECTIVES: Studying the effect of the time elapsed between mixing the steroid preparation and injection on the number and size of aggregates with sizes above 100 mu m. STUDY DESIGN: Original study in basic science. SETTING: Basic scienceMETHODS: Steroids evaluated are commonly used in Spain for ESI: betamethasone, triamcinolone, and dexamethasone. The size and number of the aggregates was determined for undiluted commercial steroid preparations in the usual amount for a single and double dosage used for ESI.Samples were examined with a Leica TCS-SP2 microscope at the first, the fifth and the 30th minute after shaking the preparations. Aggregates observed in the different preparations were manually counted and grouped in the following size range: 0-20, 20-50, 50-100, 100-300, 300-500 and > 500 mu m.Statistical analysis was carried out using the R software. Nonparametric techniques were used in the comparison of aggregate size. Global comparison of the groups using the Kruskal-Wallis test and post-hoc comparisons using the Wilcoxon test, adjusting P-values by the Holm method for multiple comparisonsRESULTS: Aggregates present in triamcinolone and betamethasone samples were statistically larger than in dexamethasone samples. Triamcinolone suspensions produced significantly larger aggregates than betamethasone five minutes after mixing. Triamcinolone preparations produced greater particle aggregates (> 500 mu m), which were not present in dexamethasone and betamethasone preparations. LIMITATIONS: Study how the human internal factors like blood elements and spinal fluid could interact with steroids and influence the size of the aggregates formed. CONCLUSIONS: This study demonstrates that the size of the particles injected depends on the type of steroid and the time allowed between mixing and injecting. The results demonstrate that waiting longer than 5 minutes between mixing and injecting can predispose the formation of potentially harmful aggregates in triamcinolone and betamethasone samples. The presence of greater particle aggregates (> 500 mu m) may occlude some important vessels and arteries with serious adverse results. Vigorous shaking of the injectable could prevent such events. KEY WORDS: Epidural steroid injection, triamcinolone, betamethasone, dexamethasone, steroid aggregates.

[Consensus document of the Spanish Society of Intensive and Critical Care Medicine and Coronary Units (SEMICYUC), the Spanish Society of Otorhinolaryngology and Head and Neck Surgery (SEORL-CCC) and the Spanish Society of Anesthesiology and Resuscitation (SEDAR) on tracheotomy in patients with COVID-19 infection]. / Documento de consenso de la Sociedad Española de Medicina Intensiva, Crítica, y Unidades Coronarias (SEMICYUC), la Sociedad Española de Otorrinolaringología y Cirugía de Cabeza y Cuello (SEORL-CCC) y la Sociedad Española de Anestesiología y Reanimación (SEDAR) sobre la traqueotomía en pacientes con COVID-19.

The current COVID-19 pandemic has rendered up to 15% of patients under mechanical ventilation. Because the subsequent tracheotomy is a frequent procedure, the three societies mostly involved (SEMICYUC, SEDAR and SEORL-CCC) have setup a consensus paper that offers an overview about indications and contraindications of tracheotomy, be it by puncture or open, clarifying its respective advantages and enumerating the ideal conditions under which they should be performed, as well as the necessary steps. Regular and emergency situations are displayed together with the postoperative measures.

Clinical study of an outbreak of postoperative mediastinitis caused by Serratia marcescens in adult cardiac surgery.

OBJECTIVES: Nosocomial infection caused by Serratia marcescens after cardiac surgery is rare but causes high rates of morbidity and mortality. Knowledge about postoperative mediastinitis due to S. marcescens is limited. The purpose of this work was to study the clinical presentation, management and outcome of an outbreak of postoperative sternal infection due to S. marcescens. METHODS: During a 7-week period, a total of 54 patients underwent open heart procedures in our hospital. A postoperative wound infection caused by S. marcescens was diagnosed in 10 patients. We performed a clinical study to investigate patient characteristics and outcomes as well as the possible source of the infection. RESULTS: The mean age of the infected patients was 74.5 ± 10 years. Mediastinitis was present in 6 cases, superficial wound infection in 3 and isolated bacteraemia in 1. Purulent exudate through the sternal incision was observed in all infected cases except in 1 patient, who presented only with bacteraemia. Serratia marcescens was isolated from the samples taken from all infected wounds. The mean time elapsed between the operation and the isolation S. marcescens was 5.9 ± 2.4 days. Response to treatment was favourable in all cases except 1, who died. Contamination of the aqueous chlorhexidine solution used to prepare the patients' skin with S. marcescens was reported. Microbiological studies demonstrated that S. marcescens strains isolated from patients and from the aqueous chlorhexidine solution belonged to the same clone. CONCLUSIONS: The use of an aqueous chlorhexidine solution contaminated with S. marcescens caused an outbreak of postoperative sternal wound infections. The time elapsed between wound contamination and signs of infection was brief, but the systemic inflammatory response and tissue necrosis were limited. Alcohol-based solutions are recommended for the prevention of surgical site infections.

Prediction of major adverse cardiac, cerebrovascular events in patients with diabetes after acute coronary syndrome.

BACKGROUND AND OBJECTIVES: The risk of major adverse cardiac and cerebrovascular events following acute coronary syndrome is increased in people with diabetes. Predicting out-of-hospital outcomes upon follow-up remains difficult, and no simple, well-validated tools exist for this population at present. We aim to evaluate several factors in a competing risks model for actionable evaluation of the incidence of major adverse cardiac and cerebrovascular events in diabetic outpatients following acute coronary syndrome. METHODS: Retrospective analysis of consecutive patients admitted for acute coronary syndrome in two centres. A Fine-Gray competing risks model was adjusted to predict major adverse cardiac and cerebrovascular events and all-cause mortality. A point-based score is presented that is based on this model. RESULTS: Out of the 1400 patients, there were 783 (55.9%) with at least one major adverse cardiac and cerebrovascular event (417 deaths). Of them, 143 deaths were due to non-major adverse cardiac and cerebrovascular events. Predictive Fine-Gray models show that the 'PG-HACKER' risk factors (gender, age, peripheral arterial disease, left ventricle function, previous congestive heart failure, Killip class and optimal medical therapy) were associated to major adverse cardiac and cerebrovascular events. CONCLUSION: The PG-HACKER score is a simple and effective tool that is freely available and easily accessible to physicians and patients. The PG-HACKER score can predict major adverse cardiac and cerebrovascular events following acute coronary syndrome in patients with diabetes.

Celia's encephalopathy and c.974dupG in BSCL2 gene: a hidden change in a known variant.

Celia's encephalopathy (progressive encephalopathy with/without lipodystrophy (PELD)) is a childhood neurodegenerative disorder with a fatal prognosis before the age of 10, due to the variant c.985C>T in the BSCL2 gene that causes a cryptic splicing site leading to skipping of exon 7. For years, different authors have reported cases of congenital generalized lipodystrophy due to the variant c.974dupG in BSCL2 associated with neurological manifestations of variable severity, although some of them clearly superimposable to PELD. To identify the molecular mechanisms responsible for these neurological alterations in two patients with c.974dupG. Clinical characterization, biochemistry, and neuroimaging studies of two girls carrying this variant. In silico analysis, PCR amplification, and BSCL2 cDNA sequencing. BSCL2-201 transcript expression, which lacks exon 7, by qPCR in fibroblasts from the index case, from a healthy child as a control and from two patients with PELD, and in leukocytes from the index case and her parents. One with a severe encephalopathy including a picture of intellectual deficiency, severe language impairment, myoclonic epilepsy, and lipodystrophy as described in PELD, dying at 9 years and 9 months of age. The other 2-year-old patient showed incipient signs of neurological involvement. In silico and cDNA sequencing studies showed that variant c.974dupG gives rise to skipping of exon 7. The expression of BSCL2-201 in fibroblasts was significantly higher in the index case than in the healthy child, although less than in the case with homozygous PELD due to c.985C>T variant. The expression of this transcript was approximately half in the healthy carrier parents of this patient. The c.974dupG variant leads to the skipping of exon 7 of the BSCL2 gene and is responsible for a variant of Celia's encephalopathy, with variable phenotypic expression.

Eficacia y seguridad de la endoscopia gastrointestinal durante un programa de entrenamiento de sedación específico para no anestesiólogos / Effectiveness and safety of gastrointestinal endoscopy during a specific sedation training program for non-anesthesiologists

Introducción: la sedación es un componente fundamental para mejorar la calidad de la sedación. Para su correcta realización es necesaria una formación adecuada. Hemos realizado un estudio con el objetivo de comparar la efectividad y la seguridad de la sedación, así como la satisfacción del paciente, cuando la sedación fue realizada por gastroenterólogos con y sin entrenamiento específico en sedación Métodos: se realizó un programa de formación a un grupo de gastroenterólogos (grupo entrenado, n = 4) y se compararon los resultados con los de otro grupo no entrenado (n = 3). Se incluyeron pacientes ASA 1-3 que se sometieron a sedación administrada por un gastroenterólogo con midazolam y fentanilo durante un periodo de 30 meses. La seguridad se evaluó en términos de tasas de complicaciones; la efectividad, como la tasa de procedimientos endoscópicos completados; y la satisfacción del paciente, mediante una encuesta telefónica el día después del procedimiento. Resultados: en total, 3.475 pacientes fueron sedados por gastroenterólogos durante el periodo de estudio. Se encontraron diferencias significativas a favor del grupo entrenado en la comparación de pruebas completadas (5,6% vs. 8,9%), una menor incidencia de sedación excesiva (1,3% vs. 8,61%) y de hipoxemia (0,72% vs. 2,49%) y menor incidencia de dolor después del procedimiento (1,8% vs. 4,3%). La satisfacción del paciente excedió el 99,5% y no hubo diferencias significativas entre ambos grupos Conclusiones: nuestro programa de formación en sedación mejora los resultados frente a quienes no han realizado dicha formación específica en términos de efectividad y de seguridad

Introduction: sedation is a key component for the improvement of sedation quality. A correct administration requires appropriate training. We performed a study to compare sedation effectiveness, safety and patient satisfaction when administered by gastroenterologists, with and without specific training. Methods: a training program enrolled a group of gastroenterologists (trained group, n = 4) and their results were compared to those from a non-trained group (n = 3). ASA 1-3 patients who had undergone sedation by a gastroenterologist using midazolam and fentanyl were included over a period of 30 months. Safety was assessed in terms of the complication rate, effectiveness was assessed via the rate of completed endoscopic procedures and patient satisfaction was evaluated via a phone interview the day after the procedure. Results: a total of 3,475 patients were sedated by gastroenterologists during the study period. Significant differences were found that favored the trained group for completed procedures (5.6% vs 8.9%). A lower rate of excessive sedation (1.3% vs 8.61%), hypoxemia (0.72% vs 2.49%) and post-procedural pain (1.8% vs 4.3%) were also achieved. Patient satisfaction surpassed 99.5% and there were no significant differences between groups. Conclusions: our sedation training program improved the effectiveness and safety outcomes when compared to sedation administered by gastroenterologists without this specific training

Estudio descriptivo de monitorización de un programa de calidad de sedación por no anestesiólogos / A descriptive monitoring study of a non-anesthetist sedation quality program

Introducción: la sedación mejora sensiblemente la calidad de la endoscopia digestiva, aunque puede tener complicaciones graves. Métodos: protocolo multidisciplinar en base a la joint comission que defina el protocolo de sedación por no anestesiólogos. Se excluyen pacientes ASA 4 o con vía aérea difícil, pruebas complejas y sedación profunda. Controlamos la calidad en base al análisis de 9 indicadores. También se monitorizan las pruebas incompletas para valorar eficacia. Resultados: la seguridad del paciente se establece en base a una incidencia de complicaciones muy baja, con una incidencia de eventos respiratorios de 1,07. Además, se encuentra una baja incidencia de hipotensión y bradicardia, al igual que del dolor durante y después de la endoscopia y una incidencia menor del 0,5% de ingresos no esperados. Los indicadores de calidad medidos nos indican la evolución de los resultados del programa. Conclusiones: la monitorización continuada de los programas de sedación en endoscopia permiten controlar las diferentes dimensiones de la calidad e implementar medidas que mejoren el proceso

Introduction: sedation substantially improves the quality of digestive endoscopy procedures but may result in severe complications. Methods: a joint commission-based multidisciplinary protocol was used to define a protocol for sedation by non-anesthesiologists. ASA 4 patients were excluded, as well as patients with a difficult airway, complex procedures and deep sedation. Quality based on the analysis of 9 indicators were monitored. Incomplete procedures were also monitored in order to assess efficacy. Results: patient safety was established based on a very low incidence of complications and a rate of respiratory events of 1.07. Furthermore, a low rate of hypotension and bradycardia was found, as well as a low rate of pain, either during or after endoscopy and an incidence of unexpected admissions lower than 0.5%. The quality indicators measured reflect the evolution of the results of the program. Conclusions: ongoing sedation program monitoring in endoscopy allows the control of different quality dimensions and the implementation of steps for process improvement

Effectiveness and safety of gastrointestinal endoscopy during a specific sedation training program for non-anesthesiologists.

INTRODUCTION: sedation is a key component for the improvement of sedation quality. A correct administration requires appropriate training. We performed a study to compare sedation effectiveness, safety and patient satisfaction when administered by gastroenterologists, with and without specific training. METHODS: a training program enrolled a group of gastroenterologists (trained group, n = 4) and their results were compared to those from a non-trained group (n = 3). ASA 1-3 patients who had undergone sedation by a gastroenterologist using midazolam and fentanyl were included over a period of 30 months. Safety was assessed in terms of the complication rate, effectiveness was assessed via the rate of completed endoscopic procedures and patient satisfaction was evaluated via a phone interview the day after the procedure. RESULTS: a total of 3,475 patients were sedated by gastroenterologists during the study period. Significant differences were found that favored the trained group for completed procedures (5.6% vs 8.9%). A lower rate of excessive sedation (1.3% vs 8.61%), hypoxemia (0.72% vs 2.49%) and post-procedural pain (1.8% vs 4.3%) were also achieved. Patient satisfaction surpassed 99.5% and there were no significant differences between groups. CONCLUSIONS: our sedation training program improved the effectiveness and safety outcomes when compared to sedation administered by gastroenterologists without this specific training.

A descriptive monitoring study of a non-anesthetist sedation quality program.

INTRODUCTION: sedation substantially improves the quality of digestive endoscopy procedures but may result in severe complications. METHODS: a joint commission-based multidisciplinary protocol was used to define a protocol for sedation by non-anesthesiologists. ASA 4 patients were excluded, as well as patients with a difficult airway, complex procedures and deep sedation. Quality based on the analysis of 9 indicators were monitored. Incomplete procedures were also monitored in order to assess efficacy. RESULTS: patient safety was established based on a very low incidence of complications and a rate of respiratory events of 1.07. Furthermore, a low rate of hypotension and bradycardia was found, as well as a low rate of pain, either during or after endoscopy and an incidence of unexpected admissions lower than 0.5%. The quality indicators measured reflect the evolution of the results of the program. CONCLUSIONS: ongoing sedation program monitoring in endoscopy allows the control of different quality dimensions and the implementation of steps for process improvement.

Validating Left Atrial Low Voltage Areas During Atrial Fibrillation and Atrial Flutter Using Multielectrode Automated Electroanatomic Mapping.

OBJECTIVES: This study aimed: 1) to determine the voltage correlation between sinus rhythm (SR) and atrial fibrillation (AF)/atrial flutter (AFL) using multielectrode fast automated mapping; 2) to identify a bipolar voltage cutoff for scar and/or low voltage areas (LVAs); and 3) to examine the reproducibility of voltage mapping in AF. BACKGROUND: It is unclear if bipolar voltage cutoffs should be adjusted depending on the rhythm and/or area being mapped. METHODS: High-density mapping was performed first in SR and afterward in induced AF/AFL. In some patients, 2 maps were performed during AF. Maps were combined to create a new one. Points of <1 mm difference were analyzed. Correlation was explored with scatterplots and agreement analysis was assessed with Bland-Altman plots. The generalized additive model was also applied. RESULTS: A total of 2,002 paired-points were obtained. A cutoff of 0.35 mV in AFL predicted a sinus voltage of 0.5 mV (95% confidence interval [CI]: 0.12 to 2.02) and of 0.24 mV in AF (95% CI: 0.11 to 2.18; specificity [SP]: 0.94 and 0.96; sensitivity [SE]: 0.85 and 0.75, respectively). When generalized additive models were used, a cutoff of 0.38 mV was used for AFL for predicting a minimum value of 0.5 mV in SR (95% CI: 0.5 to 1.6; SP: 0.94, SE: 0.88) and of 0.31 mV for AF (95% CI: 0.5 to 1.2; SP: 0.95, SE: 0.82). With regard to AF maps, there was no change in the classification of any left atrial region other than the roof. CONCLUSIONS: It is possible to establish new cutoffs for AFL and/or AF with acceptable validity in predicting a sinus voltage of <0.5 mV. Multielectrode fast automated mapping in AFL and/or AF seems to be reliable and reproducible when classifying LVAs. These observations have clinical implications for left atrial voltage distribution and in procedures in which scar distribution is used to guide pulmonary vein isolation and/or re-isolation.

Association of metreleptin treatment and dietary intervention with neurological outcomes in Celia's encephalopathy.

Celia's encephalopathy (progressive encephalopathy with/without lipodystrophy, PELD) is a recessive neurodegenerative disease that is fatal in childhood. It is caused by a c.985C>T variant in the BSCL2/seipin gene that results in an aberrant seipin protein. We evaluated neurological development before and during treatment with human recombinant leptin (metreleptin) plus a dietary intervention rich in polyunsaturated fatty acids (PUFA) in the only living patient. A 7 years and 10 months old girl affected by PELD was treated at age 3 years with metreleptin, adding at age 6 omega-3 fatty acid supplementation. Her mental age was evaluated using the Battelle Developmental Inventory Screening Test (BDI), and brain PET/MRI was performed before treatment and at age 5, 6.5, and 7.5 years. At age 7.5 years, the girl remains alive and leads a normal life for her mental age of 30 months, which increased by 4 months over the last 18 months according to BDI. PET images showed improved glucose uptake in the thalami, cerebellum, and brainstem. This patient showed a clear slowdown in neurological regression during leptin replacement plus a high PUFA diet. The aberrant BSCL2 transcript was overexpressed in SH-SY5Y cells and was treated with docosahexaenoic acid (200 µM) plus leptin (0.001 mg/ml) for 24 h. The relative expression of aberrant BSCL2 transcript was measured by qPCR. In vitro studies showed significant reduction (32%) in aberrant transcript expression. This therapeutic approach should be further studied in this devastating disease.

Más de 3 horas y menos de 3 años: Seguridad de procedimientos anestésicos en menores de 3 años sometidos a cirugía de más de 3 horas / More than 3 hours and less than 3 years: Safety of anaesthetic procedures in infants less than 3 years old subected to surgery for more the 3 hours

La alerta de la FDA de diciembre 2016, sobre la seguridad de la anestesia general y las sedaciones en pacientes menores de 3 años y en mujeres embarazadas, ha suscitado numerosas dudas sobre la actitud que deben tomar los profesionales implicados en el tratamiento de estos pacientes. Ante esta situación, las siguientes sociedades científicas médicas: Sociedad Española de Anestesia y Reanimación (SEDAR), Sociedad Española de Cirugía Pediátrica (SECP), Sociedad Española de Cuidados Intensivos Pediátricos (SECIP) y Sociedad Española de Neonatología (SENeo), han constituido un grupo de trabajo para analizar y clarificar la seguridad de estas técnicas. En este artículo concluimos que en el momento actual tanto la anestesia general como la sedación profunda deben seguir siendo consideradas como técnicas seguras, porque no existen evidencias de lo contrario en estudios con seres humanos. Esta seguridad no nos permite ignorar el problema, que debe ser seguido con atención, fundamentalmente en pacientes de menos de 3 años, sometidos a procedimientos anestésicos de más de 3 horas o a sedaciones prolongadas en las Unidades de Cuidados Intensivos Neonatales o Pediátricos (AU)

An FDA alert in December 2016 on the safety of general anesthesia and sedations in patients less than 3 years of age and pregnant women has raised doubts in relation to the attitude that professionals implicated in these procedures should adopt in relation to these specific group of patients. Confronted with this situation, the following medical scientific societies: Sociedad Española de Anestesia y Reanimación (SEDAR), Sociedad Española de Cirugía Pediátrica (SECP), Sociedad Española de Cuidados Intensivos Pediátricos (SECIP) y Sociedad Española de Neonatología (SENeo), have established a working group to analyze and clarify the safety of these techniques. In the present article we conclude that at present both general anesthesia and profound sedation are considered safe procedures because there is no evidence of the opposite in studies with human beings. However, this ascertained safety should not obviate the problem which still needs to be followed with attention, especially in patients less than 3 years of age undergoing anesthetic procedures for more than 3 hours or prolonged sedation in the Neonatal or Pediatric Intensive Care Units (AU)

Respuesta al editorial: 'Will societies of anesthesiologists partake in the take-off of nonanesthesiologist administration of propofol?' / In response to the editorial: 'Will societies of anesthesiologists partake in the take-off of non-anesthesiologist administration of propofol?'

No disponible

In response to the editorial: "Will societies of anesthesiologists partake in the take-off of non-anesthesiologist administration of propofol?"

The editorial of Dr. Dumonceau comments on the discrepancies with the declarations done in regard to the article sent by titled Alvarez J. et al "Safety of the patient in deep sedation for endoscopico digestive procedures". We do not agree in the analysis of the mortality, with comparative studies between anesthesiologists and not anesthesiologists and with the conclusion of the editorial.

[More than 3 hours and less than 3 years: Safety of anaesthetic procedures in infants less than 3 years old subected to surgery for more the 3 hours]. / Más de 3 horas y menos de 3 años: Seguridad de procedimientos anestésicos en menores de 3 años sometidos a cirugía de más de 3 horas.

An FDA alert in December 2016 on the safety of general anesthesia and sedations in patients less than 3 years of age and pregnant women has raised doubts in relation to the attitude that professionals implicated in these procedures should adopt in relation to these specific group of patients. Confronted with this situation, the following medical scientific societies: Sociedad Española de Anestesia y Reanimación (SEDAR), Sociedad Española de Cirugía Pediátrica (SECP), Sociedad Española de Cuidados Intensivos Pediátricos (SECIP) y Sociedad Española de Neonatología (SENeo), have established a working group to analyze and clarify the safety of these techniques. In the present article we conclude that at present both general anesthesia and profound sedation are considered safe procedures because there is no evidence of the opposite in studies with human beings. However, this ascertained safety should not obviate the problem which still needs to be followed with attention, especially in patients less than 3 years of age undergoing anesthetic procedures for more than 3 hours or prolonged sedation in the Neonatal or Pediatric Intensive Care Units.