A Tagging Polymorphism in Fat Mass and Obesity-Associated (FTO) Gene Is Associated with Sepsis Status in Children.

INTRODUCTION: Sepsis is one of the most common causes of death in patients admitted to intensive care units (ICUs). The development of sepsis is significantly influenced by genetic predisposition. In this study, we highlight a potential association between a variant of the fat mass and obesity-associated (FTO) gene and risk of sepsis in children and adolescents. METHODS: We investigated a first-intron tagging FTO polymorphism (rs17817449) by comparing a severe condition (SC) group, comprising 598 paediatric patients (ages 0-19 years) admitted to an ICU with fever, systemic inflammatory response syndrome (SIRS), sepsis, severe sepsis, septic shock, or multiple organ dysfunction syndrome (MODS), with a control group consisting of 616 healthy young adults. RESULTS: We observed a lower prevalence (p < 0.01; OR = 0.59, 95% CI = 0.39-0.87) of the FTO TT genotype in febrile and SIRS patients compared to patients with severe illness. There was a borderline trend towards a lower prevalence of the FTO TT genotype in the control group compared to the SC group (p < 0.09, OR = 0.81, 95% CI = 0.62-1.06). CONCLUSIONS: Our findings suggest that rs17817449, a common FTO polymorphism, may be a predictor of sepsis in paediatric patients, and that higher body weight is protective against this clinical complication.

Modern Paediatric Emergency Department: Potential Improvements in Light of New Evidence.

The increasing attendance of paediatric emergency departments has become a serious health issue. To reduce an elevated burden of medical errors, inevitably caused by a high level of stress exerted on emergency physicians, we propose potential areas for improvement in regular paediatric emergency departments. In an effort to guarantee the demanded quality of care to all incoming patients, the workflow in paediatric emergency departments should be sufficiently optimised. The key component remains to implement one of the validated paediatric triage systems upon the patient's arrival at the emergency department and fast-tracking patients with a low level of risk according to the triage system. To ensure the patient's safety, emergency physicians should follow issued guidelines. Cognitive aids, such as well-designed checklists, posters or flow charts, generally improve physicians' adherence to guidelines and should be available in every paediatric emergency department. To sharpen diagnostic accuracy, the use of ultrasound in a paediatric emergency department, according to ultrasound protocols, should be targeted to answer specific clinical questions. Combining all mentioned improvements might reduce the number of errors linked to overcrowding. The review serves not only as a blueprint for modernising paediatric emergency departments but also as a bin of useful literature which can be suitable in the paediatric emergency field.

Update on Therapeutic Drug Monitoring of Beta-Lactam Antibiotics in Critically Ill Patients-A Narrative Review.

Beta-lactam antibiotics remain one of the most preferred groups of antibiotics in critical care due to their excellent safety profiles and their activity against a wide spectrum of pathogens. The cornerstone of appropriate therapy with beta-lactams is to achieve an adequate plasmatic concentration of a given antibiotic, which is derived primarily from the minimum inhibitory concentration (MIC) of the specific pathogen. In a critically ill patient, the plasmatic levels of drugs could be affected by many significant changes in the patient's physiology, such as hypoalbuminemia, endothelial dysfunction with the leakage of intravascular fluid into interstitial space and acute kidney injury. Predicting antibiotic concentration from models based on non-critically ill populations may be misleading. Therapeutic drug monitoring (TDM) has been shown to be effective in achieving adequate concentrations of many drugs, including beta-lactam antibiotics. Reliable methods, such as high-performance liquid chromatography, provide the accurate testing of a wide range of beta-lactam antibiotics. Long turnaround times remain the main drawback limiting their widespread use, although progress has been made recently in the implementation of different novel methods of antibiotic testing. However, whether the TDM approach can effectively improve clinically relevant patient outcomes must be proved in future clinical trials.

COVID-19-Associated Paediatric Inflammatory Multisystem Syndrome (PIMS-TS) in Intensive Care: A Retrospective Cohort Trial (PIMS-TS INT).

Paediatric inflammatory multisystem syndrome temporally associated with COVID-19 (PIMS-TS) is a new disease in children and adolescents that occurs after often asymptomatic or mild COVID-19. It can be manifested by different clinical symptomatology and varying severity of disease based on multisystemic inflammation. The aim of this retrospective cohort trial was to describe the initial clinical presentation, diagnostics, therapy and clinical outcome of paediatric patients with a diagnosis of PIMS-TS admitted to one of the 3 PICUs. All paediatric patients who were admitted to the hospital with a diagnosis of paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS) during the study period were enrolled in the study. A total of 180 patients were analysed. The most common symptoms upon admission were fever (81.6%, n = 147), rash (70.6%, n = 127), conjunctivitis (68.9%, n = 124) and abdominal pain (51.1%, n = 92). Acute respiratory failure occurred in 21.1% of patients (n = 38). Vasopressor support was used in 20.6% (n = 37) of cases. Overall, 96.7% of patients (n = 174) initially tested positive for SARS-CoV-2 IgG antibodies. Almost all patients received antibiotics during in-hospital stays. No patient died during the hospital stay or after 28 days of follow-up. Initial clinical presentation and organ system involvement of PIMS-TS including laboratory manifestations and treatment were identified in this trial. Early identification of PIMS-TS manifestation is essential for early treatment and proper management of patients.

Feasibility of Mouth-to-Mouth Ventilation through FPP2 Respirator in BLS Training during COVID-19 Pandemic (MOVERESP Study): Simulation-Based Study.

BACKGROUND: Due to the COVID-19 pandemic, Basic Life Support (BLS) training has been limited to compression-only or bag-mask ventilation. The most breathable nanofiber respirators carry the technical possibility for inflation of the mannequin. The aim of this study was to assess the efficacy of mouth-to-mouth breathing through a FFP2 respirator during BLS. METHODS: In the cross-over simulation-based study, the medical students performed BLS using a breathable nanofiber respirator for 2 min on three mannequins. The quantitative and qualitative efficacy of mouth-to-mouth ventilation through the respirator in BLS training was analyzed. The primary aim was the effectivity of mouth-to-mouth ventilation through a breathable respirator. The secondary aims were mean pause, longest pause, success in achieving the optimal breath volume, technique of ventilation, and incidence of adverse events. RESULTS: In 104 students, effective breath was reached in 951 of 981 (96.9%) attempts in Adult BLS mannequin (Prestan), 822 of 906 (90.7%) in Resusci Anne, and 1777 of 1857 (95.7%) in Resusci Baby. In Resusci Anne and Resusci Baby, 28.9%/15.9% of visible chest rises were evaluated as low-, 33.0%/44.0% as optimal-, and 28.8%/35.8% as high-volume breaths. CONCLUSIONS: Mouth-to-mouth ventilation through a breathable respirator had an effectivity greater than 90%.

Central Venous Catheter Cannulation in Pediatric Anesthesia and Intensive Care: A Prospective Observational Trial.

Currently, ultrasound-guided central venous catheter (CVC) insertion is recommended in pediatric patients. However, the clinical practice may vary. The primary aim of this study was the overall success rate and the first attempt success rate in ultrasound-guided CVC insertion versus anatomic-based CVC insertion in pediatric patients. The secondary aim was the incidence of associated complications and the procedural time. The physician could freely choose the cannulation method and venous approach. Data were collected for 10 months. Overall, 179 patients were assessed for eligibility and 107 patients were included. In almost half of the patients (48.6%), the percutaneous puncture was performed by real-time ultrasound navigation. In 51.4% of the patients, the puncture was performed by the landmark method. The overall success rate was 100% (n = 52) in the real-time ultrasound navigation group, 96.4% (n = 53) in the landmark insertion group, (p = 0.496). The first percutaneous puncture success rate was 57.7% (n = 30) in the real-time ultrasound navigation group and 45.5% (n = 25) in the landmark insertion group, (p = 0.460). The data show a higher overall success rate and the first success rate in the US-guided CVC insertion group, but the difference was not statistically significant.

Airway Management in Pediatric Patients: Cuff-Solved Problem?

Traditionally, uncuffed tubes were used in pediatric patients under 8 years in pursuit of reducing the risk of postextubation stridor. Although computed tomography and magnetic resonance imaging studies confirmed that the subglottic area remains the narrowest part of pediatric airway, the use of uncuffed tubes failed to reduce the risk of subglottic swelling. Properly used cuffed tubes (correct size and correct cuff management) are currently recommended as the first option in emergency, anesthesiology and intensive care in all pediatric patients. Clinical practice particularly in the intensive care area remains variable. This review aims to analyze the current recommendation for airway management in children in emergency, anesthesiology and intensive care settings.

Ventilator-Associated Pneumonia Prevention in Pediatric Patients: Narrative Review.

Ventilator-associated pneumonia (VAP), one of the most common healthcare-associated infections in intensive care settings, is associated with significant morbidity and mortality. VAP is diagnosed in >10% of patients on mechanical ventilation, incidence rising with number of ventilator days. In recent decades, the pathophysiology of VAP, VAP risk factors and treatment have been extensively studied. In critically ill pediatric patients, mechanical issues such as insufficient tightness of the ventilator circuit (mainly due to historically based preference of uncuffed tubes) and excessive humidity in the circuit are both significant risk factors of VAP development. Protocol-based approaches to critically ill patients on mechanical ventilation, closed suctioning, upper body position, enteral feeding and selective gastric acid suppression medication have a beneficial effect on VAP incidence. In recent decades, cuffed tubes applied to the whole spectrum of critically ill pediatric patients (except neonates <2700 g of weight), together with cuff-oriented nursing care including proper cuff-pressure (<20 cm H2O) management and the use of specialized tracheal tubes with subglottic suction ports combined with close infraglottic tracheal suctioning, have been implemented. The aim of this review was to summarize the current evidence-based knowledge about the pathophysiology, risk factors, diagnosis, treatment and prevention of VAP in clinically oriented settings.

Incidence of Emergence Delirium in the Pediatric PACU: Prospective Observational Trial.

Emergence delirium (ED) is a postoperative complication in pediatric anesthesia characterized by perception and psychomotor disorder and has a negative impact on morbidity in the form of maladaptive behavior, which can last weeks after anesthesia. Patients with developed ED present with psychomotor anxiety, agitation, and are at higher risk of unintentional extraction of an intravenous cannula, self-harm and nausea and vomiting. The described incidence of ED varies between 25−80%, with a higher prevalence among children younger than 6 years of age. We aimed to determine the incidence of ED in pediatric patients (>1 month) after general anesthesia in the post-anesthesia care unit (PACU), using Paediatric Anaesthesia Emergence Delirium (PAED) score, Watcha score and Richmond agitation and sedation scale (RASS). The incidence of ED was the highest in the PAED score with cutoff ≥10 points (89.0%, n = 1088). When using PAED score >12 points, ED incidence was 19.3% (n = 236). The lowest incidence was described by Watcha and RASS scores, 18.8% (n = 230) vs. 18.1% (n = 221), respectively. The threshold for PAED ≥10 points seems to give false-positive results, whereas the threshold >12 points is more accurate. RASS scale, although intended primarily for estimation of the depth of sedation, seems to have a good predictive value for ED.

Nutrition in Pediatric Intensive Care: A Narrative Review.

Nutrition support in pediatric intensive care is an integral part of a complex approach to treating critically ill children. Smaller energy reserves with higher metabolic demands (a higher basal metabolism rate) compared to adults makes children more vulnerable to starvation. The nutrition supportive therapy should be initiated immediately after intensive care admission and initial vital sign stabilization. In absence of contraindications (unresolving/decompensated shock, gut ischemia, critical gut stenosis, etc.), the preferred type of enteral nutrition is oral or via a gastric tube. In the acute phase of critical illness, due to gluconeogenesis and muscle breakdown with proteolysis, the need for high protein delivery should be emphasized. After patient condition stabilization, the acute phase with predominant catabolism converts to the anabolic phase and intensive rehabilitation, where high energy demands are the keystone of a positive outcome.

Cerebrovascular Complications of COVID-19 Disease in Children: A Single-Center Case Series.

This work presents a case series of four children diagnosed with severe cerebrovascular disease in association with recent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, yet no patient from the group met typical diagnostic criteria for multisystem inflammatory syndrome in children. Our aim was to highlight the possible vascular involvement and coagulopathies associated with SARS-CoV-2 infection in the pediatric population. Further data are needed to better understand the pathophysiological basis of this condition in children and to ensure its optimal management.

Critically Ill Pediatric Patient and SARS-CoV-2 Infection.

In December 2019 SARS-CoV-2 initiated a worldwide COVID-19 pandemic, which is still ongoing in 2022. Although adult elderly patients with chronic preexisting diseases had been identified as the most vulnerable group, COVID-19 has also had a significant impact on pediatric intensive care. Early in 2020, a new disease presentation, multisystemic inflammatory syndrome, was described in children. Despite the vaccination that is available for all age categories, due to its selection process, new viral mutations and highly variable vaccination rate, COVID-19 remains a significant clinical challenge in adult and pediatric intensive care in 2022.

Effect of dexamethasone in patients with ARDS and COVID-19 (REMED trial)-study protocol for a prospective, multi-centre, open-label, parallel-group, randomized controlled trial.

BACKGROUND: Since December 2019, SARS-CoV-2 virus has infected millions of people worldwide. In patients with COVID-19 pneumonia in need of oxygen therapy or mechanical ventilation, dexamethasone 6 mg per day is currently recommended. However, the dose of 6 mg of dexamethasone is currently being reappraised and may miss important therapeutic potential or may prevent potential deleterious effects of higher doses of corticosteroids. METHODS: REMED is a prospective, open-label, randomised controlled trial testing the superiority of dexamethasone 20 mg (dexamethasone 20 mg on days 1-5, followed by dexamethasone 10 mg on days 6-10) vs 6 mg administered once daily intravenously for 10 days in adult patients with moderate or severe ARDS due to confirmed COVID-19. Three hundred participants will be enrolled and followed up for 360 days after randomization. Patients will be randomised in a 1:1 ratio into one of the two treatment arms. The following stratification factors will be applied: age, Charlson Comorbidity Index, CRP levels and trial centre. The primary endpoint is the number of ventilator-free days (VFDs) at 28 days after randomisation. The secondary endpoints are mortality from any cause at 60 days after randomisation; dynamics of the inflammatory marker, change in WHO Clinical Progression Scale at day 14; and adverse events related to corticosteroids and independence at 90 days after randomisation assessed by the Barthel Index. The long-term outcomes of this study are to assess long-term consequences on mortality and quality of life at 180 and 360 days. The study will be conducted in the intensive care units (ICUs) of ten university hospitals in the Czech Republic. DISCUSSION: We aim to compare two different doses of dexamethasone in patients with moderate to severe ARDS undergoing mechanical ventilation regarding efficacy and safety. TRIAL REGISTRATION: EudraCT No. 2020-005887-70. ClinicalTrials.gov NCT04663555. Registered on December 11, 2020.

Causes of Intensive Care Unit Admissions in Children with SARS-CoV-2: A Single-Centre Observational Study.

Background: The proportion of intensive care unit (ICU) admissions in children that have and have not been directly caused by SARS-CoV-2 remains unclear. The aim of the study is to analyse a cohort of children admitted to the ICU with SARS-CoV-2 and determine whether the infection was the primary cause of their hospitalisation, a significant contributor, a suspected accomplice, or an incidental finding. Methods: This was a retrospective observational study of all the children admitted to the ICU with SARS-CoV-2 from March 2020 to February 2022 from the South Moravia region. The aim of the study was to assess whether the hospitalisation was likely to be directly caused by the virus (i.e., patients with acute COVID-19; the COVID group), whether the virus was a significant contributor to the hospitalisation (i.e., patients with multisystem inflammatory syndrome in children due to COVID-19; the MIS-C group), whether it may have contributed to the worsening of their underlying disease (the WORSENING group), or whether it was an incidental finding very likely unrelated to hospitalisation where SARS-CoV-2 positivity merely placed patients in the COVID-19 unit (the ISOLATION group). The groups were compared using a series of secondary outcomes. Results: The study population represented 150 paediatric ICU cases (age 8.6; IQR 3.5−13.3 years), with 66.7% being male. The COVID group represented 32.7% of cases (49/150); MIS-C, 30% (45/150); WORSENING, 14.7% (22/150); and ISOLATION, 22.7% (34/150). The median length of hospitalisation was found for the MIS-C group (11 days; 9 days in the ICU), the COVID group (6 days; five days in the ICU), WORSENING group (4.5 days; 4.5 days in the ICU) and the ISOLATION group (5.5 days; 3.5 days in the ICU), where the difference was significant (p < 0.001). Asymptomatic and mild cases were most common in the WORSENING (36.4% and 63.6%) and ISOLATION (52.9% and 44.1%) groups. Severe and critical cases were only present in the COVID (6.1% and 12.2%) and MIS-C (4.4% and 11.1%) groups; the severity difference was significant (p < 0.001). The groups did not differ significantly in the proportion of complete recovery and short- and long-term sequelae (p = 0.09). Conclusions: Patients with acute COVID-19 accounted for one-third of all ICU admissions, patients with MIS-C accounted for approximately another third, patients with worsening underlying disease accounted for 15%, and patients with incidental findings of SARS-CoV-2 positivity accounted for one-fifth of ICU admissions. A more significant disease was seen with acute COVID-19 and MIS-C.

Videolaryngoscopy vs. Direct Laryngoscopy for Elective Airway Management in Paediatric Anaesthesia: A prospective randomised controlled trial.

BACKGROUND: The indirect visualisation of the glottic area with a videolaryngoscope could improve intubation conditions which may possibly lead to a higher success rate of the first intubation attempt. OBJECTIVE: Comparison of videolaryngoscopy and direct laryngoscopy for elective airway management in paediatric patients. DESIGN: Prospective randomised controlled trial. SETTINGS: Operating room. PARTICIPANTS: 535 paediatric patients undergoing elective anaesthesia with tracheal intubation. 501 patients were included in the final analysis. INTERVENTIONS: Patients were randomly allocated to the videolaryngoscopy group (n  = 265) and to the direct laryngoscopy group (n  = 269) for the primary airway management. MAIN OUTCOME MEASURES: The first attempt intubation success rate was assessed as the primary outcome. The secondary outcomes were defined as: the time to successful intubation (time to the first EtCO2 wave), the overall intubation success rate, the number of intubation attempts, the incidence of complications, and the impact of the length of the operator's clinical practice. RESULTS: The study was terminated after the planned interim analysis for futility. There were no significant demographic differences between the two groups. The first attempt intubation success rate was lower in the videolaryngoscopy group; 86.8% (n  = 211) vs. 92.6% (n  = 239), P = 0.046. The mean time to the first EtCO2 wave was longer in the videolaryngoscopy group at 39.0 s ±â€Š36.7 compared to the direct laryngoscopy group, 23.6 s ±â€Š24.7 (P < 0.001). There was no difference in the overall intubation success rate, in the incidence of complications nor significant difference based on the length of the clinical practice of the operator. CONCLUSIONS: The first attempt intubation success rate was lower in the videolaryngoscopy group in comparison to the direct laryngoscopy group. The time needed for successful intubation with videolaryngoscopy was longer compared with direct laryngoscopy. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT03747250.

Pediatric Patient with Ischemic Stroke: Initial Approach and Early Management.

Acute Ischemic Stroke (AIS) in children is an acute neurologic emergency associated with significant morbidity and mortality. Although the incidence of AIS in pediatric patients is considerably lower than in adults, the overall cumulative negative impact of the quality of life could be even higher in children. The age-related variable clinical presentation could result in a delay in diagnosis and could negatively influence the overall outcome. The early management should be based on early recognition, acute transfer to pediatric AIS centre, standardised approach (ABCDE), early neurologic examination together with neuroimaging (preferable Magnetic Resonance Imaging-MRI). The treatment is based on supportive therapy (normoxemia, normocapnia, normotension and normoglycemia) in combination with intravenous/intraarterial thrombolytic therapy and/or mechanical thrombectomy in selected cases. Pediatric stroke centres, together with the implementation of local stroke management protocols, could further improve the outcome of pediatric patients with AIS.

Effect of dexamethasone in patients with ARDS and COVID-19 - prospective, multi-centre, open-label, parallel-group, randomised controlled trial (REMED trial): A structured summary of a study protocol for a randomised controlled trial.

OBJECTIVES: The primary objective of this study is to test the hypothesis that administration of dexamethasone 20 mg is superior to a 6 mg dose in adult patients with moderate or severe ARDS due to confirmed COVID-19. The secondary objective is to investigate the efficacy and safety of dexamethasone 20 mg versus dexamethasone 6 mg. The exploratory objective of this study is to assess long-term consequences on mortality and quality of life at 180 and 360 days. TRIAL DESIGN: REMED is a prospective, phase II, open-label, randomised controlled trial testing superiority of dexamethasone 20 mg vs 6 mg. The trial aims to be pragmatic, i.e. designed to evaluate the effectiveness of the intervention in conditions that are close to real-life routine clinical practice. PARTICIPANTS: The study is multi-centre and will be conducted in the intensive care units (ICUs) of ten university hospitals in the Czech Republic. INCLUSION CRITERIA: Subjects will be eligible for the trial if they meet all of the following criteria: 1. Adult (≥18 years of age) at time of enrolment; 2. Present COVID-19 (infection confirmed by RT-PCR or antigen testing); 3. Intubation/mechanical ventilation or ongoing high-flow nasal cannula (HFNC) oxygen therapy; 4. Moderate or severe ARDS according to Berlin criteria: • Moderate - PaO2/FiO2 100-200 mmHg; • Severe - PaO2/FiO2 < 100 mmHg; 5. Admission to ICU in the last 24 hours. EXCLUSION CRITERIA: Subjects will not be eligible for the trial if they meet any of the following criteria: 1. Known allergy/hypersensitivity to dexamethasone or excipients of the investigational medicinal product (e.g. parabens, benzyl alcohol); 2. Fulfilled criteria for ARDS for ≥14 days at enrolment; 3. Pregnancy or breastfeeding; 4. Unwillingness to comply with contraception measurements from enrolment until at least 1 week after the last dose of dexamethasone (sexual abstinence is considered an adequate contraception method); 5. End-of-life decision or patient is expected to die within next 24 hours; 6. Decision not to intubate or ceilings of care in place; 7. Immunosuppression and/or immunosuppressive drugs in medical history: a) Systemic immunosuppressive drugs or chemotherapy in the past 30 days; b) Systemic corticosteroid use before hospitalization; c) Any dose of dexamethasone during the present hospital stay for COVID-19 for ≥5 days before enrolment; d) Systemic corticosteroids during present hospital stay for conditions other than COVID-19 (e.g. septic shock); 8. Current haematological or generalized solid malignancy; 9. Any contraindication for corticosteroid administration, e.g. • intractable hyperglycaemia; • active gastrointestinal bleeding; • adrenal gland disorders; • presence of superinfection diagnosed with locally established clinical and laboratory criteria without adequate antimicrobial treatment; 10. Cardiac arrest before ICU admission; 11. Participation in another interventional trial in the last 30 days. INTERVENTION AND COMPARATOR: Dexamethasone solution for injection/infusion is the investigational medicinal product as well as the comparator. The trial will assess two doses, 20 mg (investigational) vs 6 mg (comparator). Patients in the intervention group will receive dexamethasone 20 mg intravenously once daily on day 1-5, followed by dexamethasone 10 mg intravenously once daily on day 6-10. Patients in the control group will receive dexamethasone 6 mg day 1-10. All authorized medicinal products containing dexamethasone in the form of solution for i.v. injection/infusion can be used. MAIN OUTCOMES: Primary endpoint: Number of ventilator-free days (VFDs) at 28 days after randomisation, defined as being alive and free from mechanical ventilation. SECONDARY ENDPOINTS: a) Mortality from any cause at 60 days after randomisation; b) Dynamics of inflammatory marker (C-Reactive Protein, CRP) change from Day 1 to Day 14; c) WHO Clinical Progression Scale at Day 14; d) Adverse events related to corticosteroids (new infections, new thrombotic complications) until Day 28 or hospital discharge; e) Independence at 90 days after randomisation assessed by Barthel Index. The long-term outcomes of this study are to assess long-term consequences on mortality and quality of life at 180 and 360 days through telephone structured interviews using the Barthel Index. RANDOMISATION: Randomisation will be carried out within the electronic case report form (eCRF) by the stratified permuted block randomisation method. Allocation sequences will be prepared by a statistician independent of the study team. Allocation to the treatment arm of an individual patient will not be available to the investigators before completion of the whole randomisation process. The following stratification factors will be applied: • Age <65 and ≥ 65; • Charlson Comorbidity index (CCI) <3 and ≥3; • CRP <150 mg/L and ≥150 mg/L • Trial centre. Patients will be randomised in a 1 : 1 ratio into one of the two treatment arms. Randomisation through the eCRF will be available 24 hours every day. BLINDING (MASKING): This is an open-label trial in which the participants and the study staff will be aware of the allocated intervention. Blinded pre-planned statistical analysis will be performed. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): The sample size is calculated to detect the difference of 3 VFDs at 28 days (primary efficacy endpoint) between the two treatment arms with a two-sided type I error of 0.05 and power of 80%. Based on data from a multi-centre randomised controlled trial in COVID-19 ARDS patients in Brazil and a multi-centre observational study from French and Belgian ICUs regarding moderate to severe ARDS related to COVID-19, investigators assumed a standard deviation of VFD at 28 days as 9. Using these assumptions, a total of 142 patients per treatment arm would be needed. After adjustment for a drop-out rate, 150 per treatment arm (300 patients per study) will be enrolled. TRIAL STATUS: This is protocol version 1.1, 15.01.2021. The trial is due to start on 2 February 2021 and recruitment is expected to be completed by December 2021. TRIAL REGISTRATION: The study protocol was registered on EudraCT No.:2020-005887-70, and on December 11, 2020 on ClinicalTrials.gov (Title: Effect of Two Different Doses of Dexamethasone in Patients With ARDS and COVID-19 (REMED)) Identifier: NCT04663555 with a last update posted on February 1, 2021. FULL PROTOCOL: The full protocol (version 1.1) is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the standard formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Difficult airway prediction in paediatric anaesthesia (Diffair): Prospective observational study.

BACKGROUND: The incidence of difficult airway in paediatric patients is lower than that the adult population, and the majority should be predictable. AIMS: The primary aim of this trial was to evaluate the incidence of difficult airway in pediatric patients. The secondary aim was to predict difficult airway in these patients. METHODS: Paediatric patients undergoing elective surgery under general anaesthesia in a tertiary university hospital were examined, and a panel of difficult airway prediction tests was performed. We recorded the incidence, risk factors for difficult airway and events associated with difficult airway together with the sensitivity and specificity of tests for difficult airway and events associated with difficult airway prediction. RESULTS: We prospectively included 389 paediatric patients. The incidence of difficult airway was 3.6%; the incidence of events associated with difficult airway was 10%. The sensitivity for prediction of events associated with difficult airway during the pre-anaesthesia evaluation was 5.3% with the specificity 93.3%. In the operating room, the sensitivity of prediction was 15% with 97.8% specificity. CONCLUSION: We found minimal efficacy for preanaesthesia difficult airway prediction.

Rapid sequence induction: An international survey.

BACKGROUND: Rapid sequence induction (RSI) is a standard procedure, which should be implemented in all patients with a risk of aspiration/regurgitation during anaesthesia induction. OBJECTIVE: The primary aim was to evaluate clinical practice in RSI, both in adult and paediatric populations. DESIGN: Online survey. SETTINGS: A total of 56 countries. PARTICIPANTS: Members of the European Society of Anaesthesiology. MAIN OUTCOME MEASURES: The aim was to identify and describe the actual clinical practice of RSI related to general anaesthesia. RESULTS: From the 1921 respondents, 76.5% (n=1469) were qualified anaesthesiologists. When anaesthetising adults, the majority (61.7%, n=1081) of the respondents preoxygenated patients with 100% O2 for 3 min and 65.9% (n=1155) administered opioids during RSI. The Sellick manoeuvre was used by 38.5% (n=675) and was not used by 37.4% (n=656) of respondents. First-line medications for a haemodynamically stable adult patient were propofol (90.6%, n=1571) and suxamethonium (56.0%, n=932). Manual ventilation (inspiratory pressure <12 cmH2O) was used in 35.5% (n=622) of respondents. In the majority of paediatric patients, 3 min of preoxygenation (56.6%, n=817) and opioids (54.9%, n=797) were administered. The Sellick manoeuvre and manual ventilation (inspiratory pressure <12 cmH2O) in children were used by 23.5% (n=340) and 35.9% (n=517) of respondents, respectively. First-line induction drugs for a haemodynamically stable child were propofol (82.8%, n=1153) and rocuronium (54.7%, n=741). CONCLUSION: We found significant heterogeneity in the daily clinical practice of RSI. For patient safety, our findings emphasise the need for international RSI guidelines. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03694860.