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Background Postoperative bleeding is a major problem in children undergoing complex pediatric cardiac surgery. The primary aim of this prospective observational study was to evaluate the effect of an institutional approach consisting of early preventive fibrinogen, prothrombin complex and platelets administration on coagulation parameters and postoperative bleeding in children. The secondary aim was to study the rate of re-intervention and postoperative transfusion, the occurrence of thrombosis, length of mechanical ventilation, ICU stay and mortality. Methods In fifty children (age 0–6 years) with one or more predefined risk factors for bleeding after cardiopulmonary bypass (CPB), thrombelastography (TEG) and standard coagulation parameters were measured at baseline (T1), after CPB and reversal of heparin (T2), at sternal closure (T3) and after 12 h in the ICU (T4). Clinical bleeding was evaluated by the surgeon at T2 and T3 using a numeric rating scale (NRS, 0–10). Results After CPB and early administration of fibrinogen, prothrombin complex and platelets, the clinical bleeding evaluation score decreased from a mean value of 6.2 ± 1.9 (NRS) at T2 to a mean value of 2.1 ± 0.8 at T3 (NRS; P P r = 0.70, P − 1) correlated significantly with weight (r = − 0.42, P = 0.002), priming volume as percentage of estimated blood volume (r = 0.30, P = 0.034), minimum CPB temperature (r = − 0.30, P = 0.033) and the change in clinical bleeding evaluation from T2 to T3 (r = 0.71, P 10% of estimated blood volume) was 8%. No child required a surgical re-intervention, and no cases of thrombosis were observed. Hospital mortality was 0%. Conclusion In this observational study of children with an increased risk of bleeding after CPB, an early preventive therapy with fibrinogen, prothrombin complex and platelets guided by clinical bleeding evaluation and TEG reduced bleeding and improved TEG and standard coagulation parameters significantly, with no occurrence of thrombosis or need for re-operation. Trial registration German Clinical Trials Register DRKS00018109 (retrospectively registered 27th August 2019).

Background Neonates and infants with congenital heart disease undergoing general anesthesia have an increased risk for critical cardiovascular events. Etomidate produces very minimal changes in hemodynamic parameters in older children with congenital heart disease. There is a lack of studies evaluating the effect of etomidate on systemic and regional cerebral perfusion in neonates and infants with congenital heart disease. Aim The aim of this prospective observational study was to evaluate the effect of etomidate on systemic and regional cerebral perfusion in neonates and infants with congenital heart disease. Methods In fifty infants aged 0-11 months (24% neonates n = 12) with congenital heart disease, mean arterial blood pressure, cardiac index using electrical cardiometry, and regional cerebral oxygen saturation using near-infrared spectroscopy were measured at baseline and 1, 3, 5, and 10 minutes after induction by 0.4 mg kg-1 etomidate. Hypotension was defined as a mean arterial blood pressure under 35 mm Hg and cerebral desaturation as a regional cerebral oxygen saturation of less than 80% of baseline. Results Mean arterial blood pressure, cardiac index, and regional cerebral oxygen saturation remained stable above the predefined limits. Mean arterial blood pressure decreased slightly within a physiological range after 3 minutes (P = .005, 95% CI:-5.9 to -1.0). No significant change in cardiac index could be observed. Conclusion Etomidate 0.4mg kg-1 does not impair systemic or regional cerebral perfusion in neonates or infants with congenital heart disease.

Current paediatric anaesthetic fasting guidelines have recommended conservative fasting regimes for many years and have not altered much in the last decades. Recent publications have employed more liberal fasting regimes with no evidence of increased aspiration or regurgitation rates. In this first solely paediatric European Society of Anaesthesiology and Intensive Care (ESAIC) pre-operative fasting guideline, we aim to present aggregated and evidence-based summary recommendations to assist clinicians, healthcare providers, patients and parents. We identified six main topics for the literature search: studies comparing liberal with conservative regimens; impact of food composition; impact of comorbidity; the use of gastric ultrasound as a clinical tool; validation of gastric ultrasound for gastric content and gastric emptying studies; and early postoperative feeding. The literature search was performed by a professional librarian in collaboration with the ESAIC task force. Recommendations for reducing clear fluid fasting to 1 h, reducing breast milk fasting to 3 h, and allowing early postoperative feeding were the main results, with GRADE 1C or 1B evidence. The available evidence suggests that gastric ultrasound may be useful for clinical decision-making, and that allowing a 'light breakfast' may be well tolerated if the intake is well controlled. More research is needed in these areas as well as evaluation of how specific patient or treatment-related factors influence gastric emptying.

Background Exhaled propofol concentrations correlate with propofol concentrations in adult human blood and the brain tissue of rats, as well as with electroencephalography (EEG) based indices of anesthetic depth. The pharmacokinetics of propofol are however different in children compared to adults. The value of exhaled propofol measurements in pediatric anesthesia has not yet been investigated. Breathing system filters and breathing circuits can also interfere with the measurements. In this study, we investigated correlations between exhaled propofol (exP) concentrations and the Narkotrend Index (NI) as well as calculated propofol plasma concentrations. Methods A multi-capillary-column (MCC) combined with ion mobility spectrometry (IMS) was used to determine exP. Optimal positioning of breathing system filters (near-patient or patient-distant) and sample line (proximal or distal to filter) were investigated. Measurements were taken during induction (I), maintenance (M) and emergence (E) of children under total intravenous anesthesia (TIVA). Correlations between ExP concentrations and NI and predicted plasma propofol concentrations (using pediatric pharmacokinetic models Kataria and Paedfusor) were assessed using Pearson correlation and regression analysis. Results Near-patient positioning of breathing system filters led to continuously rising exP values when exP was measured proximal to the filters, and lower concentrations when exP was measured distal to the filters. The breathing system filters were therefore subsequently attached between the breathing system tubes and the inspiratory and expiratory limbs of the anesthetic machine. ExP concentrations significantly correlated with NI and propofol concentrations predicted by pharmacokinetic models during induction and maintenance of anesthesia. During emergence, exP significantly correlated with predicted propofol concentrations, but not with NI. Conclusion In this study, we demonstrated that exP correlates with calculated propofol concentrations and NI during induction and maintenance in pediatric patients. However, the correlations are highly variable and there are substantial obstacles: Without patient proximal placement of filters, the breathing circuit tubing must be changed after each patient, and furthermore, during ventilation, a considerable additional loss of heat and moisture can occur. Adhesion of propofol to plastic parts (endotracheal tube, breathing circle) may especially be problematic during emergence. Trial Registration The study was registered in the German registry of clinical studies (DRKS-ID: DRKS00015795).

Background Despite well-defined recommendations, prolonged fasting times for clear fluids and solids are still common before elective surgery in adults. Extended fasting times may lead to discomfort, thirst, hunger and physiological dysfunctions. Previous studies have shown that prolonged fasting times are frequently caused by patients being misinformed as well as inadequate implementation of the current guidelines by medical staff. This study aimed to explore how long elective surgery patients fast in a German secondary care hospital before and after the introduction of an educational note for patients and re-training for the medical staff. Methods A total of 1002 patients were enrolled in this prospective, non-randomised interventional study. According to the power calculation, in the first part of the study actual fasting times for clear fluids and solids were documented in 502 consecutive patients, verbally instructed as usual regarding the recommended fasting times for clear fluids (2 h) and solids (6 h). Subsequently, we implemented additionally to the verbal instruction a written educational note for the patients, including the recommended fasting times. Furthermore, the medical staff was re-trained regarding the fasting times using emails, newsletters and employee meetings. Thereafter, another 500 patients were included in the study. We hypothesised, that after these quality improvement procedures, actual fasting times for clear fluids and solids would be more accurate on time. Results Actual fasting times for clear fluids were in the median 11.3 (interquartile range 6.8–14.3; range 1.5–25.5) h pre-intervention, and were significantly reduced to 5.0 (3.0–7.2; 1.5–19.8) h after the intervention (median difference (95%CI) − 5.5 (− 6.0 to − 5.0) h). The actual fasting times for solids also decreased significantly, but only from 14.5 (12.1–17.2; 5.4–48.0) h to 14.0 (12.0–16.3; 5.4–32.0) h after the interventions (median difference (95%CI) − 0.52 (− 1.0 to − 0.07) h). Conclusions The study showed considerably extended actual fasting times in elective adult surgical patients, which were significantly reduced by simple educational/training interventions. However, the actual fasting times still remained considerably longer than defined in recommended guidelines, meaning further process optimisations like obligatory fluid intake in the early morning are necessary to improve patient comfort and safety in future. Trial registration German registry of clinical studies (DRKS-ID: DRKS 00020530, retrospectively registered).

BACKGROUND A preliminary national audit of real fasting times including 3324 children showed that the fasting times for clear fluids and light meals were frequently shorter than recommended in current guidelines, but the sample size was too small for subgroup analyses. AIMS Therefore, the primary aim of this extended study with more participating centers and a larger sample size was to determine whether shortened fasting times for clear fluids or light meals have an impact on the incidence of regurgitation or pulmonary aspiration during general anesthesia in children. The secondary aim was to evaluate the impact of age, emergent status, ASA classification, induction method, airway management or surgical procedure. METHODS After the Ethics Committee's approval, at least more than 10 000 children in total were planned to be enrolled for this analysis. Patient demographics, real fasting times, anesthetic and surgical procedures, and occurrence of target adverse events defined as regurgitation or pulmonary aspiration were documented using a standardized case report form. RESULTS At fifteen pediatric centers, 12 093 children scheduled for surgery or interventional procedures were included between October 2018 and December 2019. Fasting times were shorter than recommended in current guidelines for large meals in 2.5%, for light meals in 22.4%, for formula milk in 5.3%, for breastmilk in 10.9%, and for clear fluids in 39.2%. Thirty-one cases (0.26%) of regurgitation, ten cases (0.08%) of suspected pulmonary aspiration, and four cases (0.03%) of confirmed pulmonary aspiration were reported, and all of them recovered quickly without any consequences. Fasting times for clear fluids shortened from 2 hours to 1 hour did not affect the incidence of adverse events (upper limit 95% CI 0.08%). The sample size of the cohort with fasting times for light meals shorter than 6 hours was too small for a subgroup analysis. An age between one and 3 years (odds ratio 2.7,95% CI 1.3 to 5.8%; P

BACKGROUND While many clinics have changed their local regimen toward a more liberal policy regarding clear fluid fasting for general anesthesia, there is a lack of studies evaluating gastric emptying time in a clinical setting. AIMS Based on this and before implementation of a more liberal preoperative clear fluid fasting policy for children, we studied gastric emptying time of clear fluids in children and hypothesized that the mean gastric emptying time would be 1 hour. METHODS Between March and December 2019, children scheduled for general anesthesia at our University Children's Hospital were enrolled in this prospective observational study. After overnight fasting, gastric emptying was examined by sonographic measurements of the gastric antral area before and 5, 15, 30, 45, and 60 minutes after intake of water or fruit juice. RESULTS Twenty-six children were enrolled in this study, and 24 aged 11 (range 4-17) years were included for statistical analysis. The median ingested fluid volume was 4.7 (range 1.8-11.8) mL kg-1 . The gastric antral area of the children initially increased and subsequently decreased after intake of clear fluids and correlated significantly with fasting time (r = -0.55, P 5 mL kg-1 . There was no difference in the gastric antral area between water and fruit juice. Using a linear regression model, the calculated mean gastric emptying time of clear fluids was 52 minutes. CONCLUSION This study showed that the gastric emptying time of children after intake up to 5 mL kg-1 clear fluids was

OBJECTIVES Current guidelines recommend 6 h of fasting for solids before anaesthesia. However, prolonged fasting may lead to discomfort, hunger, thirst, misbehaviour and lipolysis. To prevent this, a more liberal fasting regimen has been empirically implemented in our children's hospital, allowing a shorter fasting time of 4 h for a standardised light breakfast. AIM The aim of this study was to determine the gastric emptying time after a standardised light breakfast in healthy children. DESIGN A prospective observational noninterventional study. METHODS After fasting overnight, the children had a standardised light breakfast. Before and afterwards, ultrasound examinations of the gastric antrum were performed hourly to determine the gastric antral area (GAA), which is a surrogate parameter for gastric volume in children in the right lateral position (RLP). Demographic data and fasting times are presented as mean ± SD (range) and GAA as median (interquartile range). RESULTS Twenty-two children aged 7.8 (2.5 to 13.6) years volunteered for this study. After fasting overnight [735 ± 120 (467 to 930) min], the initial GAA was 3.06 (2.35 to 4.03) cm in RLP. After the light breakfast, GAA in RLP initially increased and decreased subsequently. After 4 h, GAA in RLP was lower than the initial value (median of differences -0.54, 95% confidence interval -1.00 to -0.07, P

Background: During cardiopulmonary bypass (CPB) in children, anesthesia maintained by sevoflurane administered via the oxygenator is increasingly common. Anesthetic uptake and requirement may be influenced by the non-physiological conditions during hypothermic CPB. Narcotrend-processed EEG monitoring may, therefore, be useful to guide the administration of sevoflurane during this phase. Objective: The objective of this prospective, clinical, observational study was to assess the correlation between body temperature, Narcotrend Index (NI) and administered sevoflurane in children during CPB. Methods: Forty-four children aged 0 to 10 years undergoing hypothermic cardiac surgery were studied. On bypass, anesthesia was maintained with sevoflurane administered via the oxygenator of the heart-lung machine. Nasopharyngeal temperature, NI and minimum alveolar concentration (MAC) of sevoflurane were recorded in intervals of 10 minutes. Expiratory gas was sampled from the oxygenator’s sole expiratory port via a separate connecting line and the MAC was measured by the agent analyzer of the anesthesia machine. Results: Raw (r = 0.74) and corrected (r = 0.73) r-values show that narcosis depth (as indicated by NI) can primarily be explained by the interaction of MAC and temperature. The analysis of variance (without the interaction term) confirms the significant and independent association of both factors, MAC (pConclusion: Perfusionists and anesthetists should be aware of the results of processed electroencephalograph (EEG) monitoring during CPB. Sevoflurane requirements differ inter-individually; they may decrease during cooling and increase during rewarming. Therefore, it seems reasonable to include the results of processed EEG monitoring when administering sevoflurane during CPB in children, but further studies are necessary to confirm this thesis.

Background Infants undergoing general anaesthesia have an increased risk of severe respiratory and cardiovascular critical events. Awake caudal anaesthesia is an alternative for small infants undergoing minor lower abdominal surgery. While clinical experience has shown stable intra-operative haemodynamic conditions, there are no studies evaluating systemic and regional cerebral perfusion during such a procedure. Objectives The purpose of this study was to evaluate the effects of awake caudal anaesthesia on systemic and regional cerebral perfusion in small infants. Design A prospective observational cohort study. Setting Clinic of Anaesthesiology, University Children's Hospital, between November 2017 and June 2018. Patients Twenty small infants (postmenstrual age 36 to 54 weeks, weight 1800 to 5700 g) scheduled for lower abdominal surgery under awake caudal anaesthesia were enrolled in this study. Intervention Standard monitoring was expanded to include cardiac index using electrical velocimetry and regional cerebral oxygen saturation using near infrared spectroscopy. The caudal block was performed with 0.3% ropivacaine 1 ml kg Hypotension was defined as mean arterial blood pressure (BP) less than 35 mmHg and regional cerebral desaturation as regional cerebral oxygen saturation less than 80% of baseline. Main outcomes Mean arterial BP, cardiac index and regional cerebral oxygen saturation parameters under awake caudal anaesthesia. Results Mean arterial BP, cardiac index and regional cerebral oxygen saturation remained above the predefined lower limits. No episodes of hypotension or regional cerebral desaturation were observed. Operation time was 35 ± 13 (range 20 to 71) min. The infants were discharged to the neonatal ward after the end of surgery, and milk was fed 22 ± 15 (range 6 to 55) min thereafter. Five preterm infants experienced self-limiting episodes of apnoea intra-operatively. Conclusion The current study shows that awake caudal anaesthesia does not impair systemic and regional cerebral perfusion in small infants. Trial registration German registry of clinical studies (DRKS-ID: 800015742).

BACKGROUND Prolonged fasting before anesthesia is still common in children. Shortened fasting times may improve the metabolic and hemodynamic condition during induction of anesthesia and the perioperative experience for parents and children and simplify perioperative management. As a consequence, some centers in Germany have reduced fasting requirements, but the national guidelines are still unchanged. AIMS This prospective multicenter observational study was initiated by the Scientific Working Group for Pediatric Anesthesia of the German Society of Anesthesiology and Intensive Care Medicine to evaluate real fasting times and the incidence of pulmonary aspiration before a possible revision of national fasting guidelines. METHODS After the Ethics Committee's approval, at least 3000 children were planned to be enrolled for this analysis. Patient demographics, real fasting times, anesthetic and surgical procedures and occurrence of regurgitation or pulmonary aspiration were documented using a standardized case report form. Results were presented as median [interquartile range] (range) or incidence (percentage). RESULTS At ten pediatric centers, 3324 children were included between October 2018 and May 2019. The real fasting times for large meals were 14 [12.2-15.6] (0.5-24) hours, for light meals 9 [5.6-13.3] (0.25-28.3) hours, for formula milk 5.8 [4.5-7.4] (0.9-24) hours, for breast milk 4.8 [4.2-6.3] (1.3-25.3) hours and for clear fluids 2.7 [1.5-6] (0.03-22.8) hours. Prolonged fasting (deviation from guideline >2 hours) was reported for large meals in 88.3%, for light meals in 54.7%, for formula milk in 44.4%, for breast milk in 25.8% and for clear fluids in 34.2%. Eleven cases (0.33%) of regurgitation, four cases (0.12%) of suspected pulmonary aspiration and two cases (0.06%) of confirmed pulmonary aspiration were reported; all of them could be extubated after the end of the procedure and recovered without any incidents. CONCLUSION This study shows that prolonged fasting is still common in pediatric anesthesia in Germany that pulmonary aspiration with postoperative respiratory distress is rare and that improvements to current local fasting regimens and national fasting guidelines are urgently needed.

BACKGROUND In paediatric anaesthesia, pre-operative fasting should be short to prevent discomfort, hunger, thirst and metabolic disorders. Current European guidelines recommend pre-operative fasting times of 4 h for breast milk and 6 h for formula milk in infants, whereas some national guidelines allow both until 4 h before anaesthesia. OBJECTIVE We evaluated the gastric emptying times of preterm infants after breast milk and formula milk, hypothesising that the mean gastric emptying time would be less than 4 h. DESIGN A prospective, observational, noninterventional cohort study. SETTING Neonatal ICU of a university hospital from August to September 2017. PATIENTS Twenty-two infants with a postmenstrual mean ± SD (range) age of 35 ± 2 (32 to 40) weeks were included. Based on their prescription plan, 10 infants received breast milk and 12 received formula milk with a total volume of 50 ± 16 (24 to 70) ml. INTERVENTIONS Gastric emptying was examined by sonographic measurements of the gastric antral area (GAA) before (FT0) and hourly after breast milk or formula milk feeding (FT1 to FT3). MAIN OUTCOME MEASURES Estimated gastric emptying time after enteral feeding with breast milk and formula milk in preterm infants. RESULTS The GAA of the preterm infants initially increased and subsequently decreased after feeding. GAA correlated significantly with fasting time (r = -0.53, P

BACKGROUND Sevoflurane induction followed by intravenous anesthesia is a widely used technique to combine the benefits of an easier and less traumatic venipuncture after sevoflurane inhalation with a recovery with less agitation, nausea, and vomiting after total intravenous anesthesia (TIVA). Combination of two different anesthetics may lead to unwanted burst suppression in the electroencephalogram (EEG) during the transition phase. OBJECTIVE The objective of this prospective clinical observational study was to identify the optimal initial propofol bolus dose for a smooth transition from sevoflurane induction to TIVA using the EEG Narcotrend Index (NI). METHODS Fifty children aged 1-8 years scheduled for elective pediatric surgery were studied. After sevoflurane induction and establishing of an intravenous access, a propofol bolus dose range 0-5 mg·kg-1 was administered at the attending anesthetist's discretion to maintain a NI between 20 and 64, and sevoflurane was stopped. Anesthesia was continued as TIVA with a propofol infusion dose of 15 mg·kg-1 ·h-1 for the first 15 min, followed by stepwise reduction according to McFarlan's pediatric infusion regime, and remifentanil 0.25 μg·kg-1 ·min-1 . Endtidal concentration of sevoflurane, NI, and hemodynamic data were recorded during the whole study period using a standardized case report form. Propofol plasma concentrations were calculated using the paedfusor dataset and a TIVA simulation program. RESULTS Median endtidal concentration of sevoflurane at the time of administration of the propofol bolus was 5.1 [IQR 4.7-5.9] Vol%. The median propofol bolus dose was 1.2 [IQR 0.9-2.5] mg·kg-1 and median NI thereafter was 33 [IQR 23-40]. Nine children presented with a NI 13-20 and three children with burst suppression in the EEG (NI 0-12); all of them received an initial propofol bolus dose >2 mg·kg-1 . Regression equation demonstrated that NI 20-64 was achieved with a 95% probability when using a propofol bolus dose of 1 mg·kg-1 after sevoflurane induction. Decrease in mean arterial blood pressure correlated significantly with propofol bolus dose (P = 0.038). After 25 min of TIVA, children younger than 2 years had a higher NI (median difference 14.0, 95%CI: 6.0-20.0, P = 0.001), higher deviations from the expected Narcotend Index (median difference 4.1, 95%CI: 3.9-4.2, P < 0.001) and lower calculated propofol plasma concentrations (median difference 0.2 μg·ml-1 , 95% CI: 0.1-0.3 μg·ml-1 , P < 0.001) than older children. CONCLUSION After sevoflurane induction, a reduced propofol bolus dose of 1 mg·kg-1 followed by TIVA according to McFarlan's regime resulted in a NI within the recommended range in children aged 1-8 years. During the course of TIVA, children younger than 2 years displayed higher NI values and more pronounced interindividual variation. Processed EEG monitoring is recommended to find adequate individual age-dependent doses.

BACKGROUND In contrast to preoperative fasting guidelines in paediatric anaesthesia, actual fasting times are often too long. OBJECTIVE The objective of this study was to evaluate the effect of preoperative fasting on glucose concentration, ketone bodies and acid-base balance in children. DESIGN A prospective, noninterventional, clinical observational study. SETTING A single-centre trial, study period from June 2014 to November 2014. PATIENTS One hundred children aged 0 to 36 months scheduled for elective paediatric surgery. MAIN OUTCOME MEASURES Patient demographics, fasting times, haemodynamic data, glucose and ketone body concentrations, and acid-base parameters after induction of anaesthesia were documented using a standardised case report form. RESULTS Mean fasting period was 7.8 ± 4.5 (3.5 to 20) h, and deviation from guideline (ΔGL) was 3.3 ± 3.2 (-2 to 14) h. Linear regression showed a significant correlation between fasting times and ketone bodies, anion gap, base excess, osmolality as well as bicarbonate (for each, P < 0.05), but not glucose or lactate. In children with ΔGL more than 2 h (54%), ketone bodies, osmolality and anion gap were significantly higher and base excess significantly lower than children with ΔGL less than 2 h (for each, P < 0.05). CONCLUSION After prolonged preoperative fasting, children younger than 36 months can present with ketoacidosis and (low) normal blood glucose concentrations. Actual fasting times should be optimised according to existing guidelines. In small infants, deviations from fasting guidelines should be as short as possible and not longer than 2 h.

Background: In older children, different electroencephalogram-based algorithms for measuring depth of anesthesia displayed a similar performance as in adults, but in infants they have not displayed the same reliability so far. According to the individual developmental state, the Narcotrend distinguishes "differentiated" electroencephalograms, which can be classified using the full Narcotrend Index scale, from "undifferentiated" electroencephalograms, which are classified using a scale with fewer stages. Objective: The objective of this prospective clinical observational study was to assess the feasibility and performance of the Narcotrend monitor in children

Summary Background In pediatric anesthesia, preoperative fasting guidelines are still often exceeded. Objective The objective of this noninterventional clinical observational cohort study was to evaluate the effect of an optimized preoperative fasting management (OPT) on glucose concentration, ketone bodies, acid–base balance, and change in mean arterial blood pressure (MAP) during induction of anesthesia in children. Methods Children aged 0–36 months scheduled for elective surgery with OPT (n = 50) were compared with peers studied before optimizing preoperative fasting time (OLD) (n = 50) who were matched for weight, age, and height. Results In children with OPT (n = 50), mean fasting time (6.0 ± 1.9 h vs 8.5 ± 3.5 h, P 2 h 8% vs 70%), ketone bodies (0.2 ± 0.2 mmol·l−1 vs 0.6 ± 0.6 mmol·l−1, P < 0.001), and incidence of hypotension (MAP