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 < .01) and emergent procedures (odds ratio 2.8,95% CI 1.4 to 5.7;P < .01) increased the incidence of adverse events, whereas ASA classification, induction method, or surgical procedure had no influence. The clear fluid fasting times were shortest under 6/4/0 as compared to 6/4/1 and 6/4/2 fasting regimens, all with an incidence of 0.3% for adverse events. Conclusion This study shows that a clear fluid fasting time shortened from 2 hours to 1 hour does not affect the incidence of regurgitation or pulmonary aspiration, that an age between one and 3 years and emergent status increase the incidence of regurgitation or pulmonary aspiration, and that pulmonary aspiration followed by postoperative respiratory distress is rare and usually shows a quick recovery.
(1) Background: Data on coronavirus 2 infection during pregnancy vary. We aimed to describe maternal characteristics and clinical presentation of SARS-CoV-2 positive women requiring intensive care treatment for COVID-19 during pregnancy and postpartum period based on data of a comprehensive German surveillance system in obstetric patients. (2) Methods: Data from COVID-19 Related Obstetric and Neonatal Outcome Study (CRONOS), a prospective multicenter registry for SARS-CoV-2 positive pregnant women, was analyzed with respect to ICU treatment. All women requiring intensive care treatment for COVID-19 were included and compared regarding maternal characteristics, course of disease, as well as maternal and neonatal outcomes. (3) Results: Of 2650 cases in CRONOS, 101 women (4%) had a documented ICU stay. Median maternal age was 33 (IQR, 30–36) years. COVID-19 was diagnosed at a median gestational age of 33 (IQR, 28–35) weeks. As the most invasive form of COVID-19 treatment interventions, patients received either continuous monitoring of vital signs without further treatment requirement (n = 6), insufflation of oxygen (n = 30), non-invasive ventilation (n = 22), invasive ventilation (n = 28), or escalation to extracorporeal membrane oxygenation (n = 15). No significant clinical differences were identified between patients receiving different forms of ventilatory support for COVID-19. Prevalence of preterm delivery was significantly higher in women receiving invasive respiratory treatments. Four women died of COVID-19 and six fetuses were stillborn. (4) Conclusions: Our cohort shows that progression of COVID-19 is rare in pregnant and postpartum women treated in the ICU. Preterm birth rate is high and COVID-19 requiring respiratory support increases the risk of poor maternal and neonatal outcome.
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.
Introduction Modified fluid gelatin 4% is approved for use in children, but there is still a surprising lack of clinical studies including large numbers of pediatric patients. Therefore, we performed a European prospective noninterventional multicenter study to evaluate the use of a modified fluid gelatin 4% in saline (sal‐GEL) or an acetate‐containing balanced electrolyte solution (bal‐GEL) in children undergoing major pediatric surgery. Aims The primary aim was to assess the indications and dosing of modified fluid gelatin, and the secondary aim was to assess the safety and efficacy, focusing, in particular, on routinely collected clinical parameters. Methods Children aged up to 12 years with ASA risk scores of I‐III receiving sal‐GEL or bal‐GEL were followed perioperatively. Demographic data, surgical procedures performed, anesthesia, hemodynamic and laboratory data, adverse events, and adverse drug reactions were documented using a standardized case report form. Results 601 children that were investigated at 13 European pediatric centers from May 2015 to March 2020 (sal‐GEL 20.1%, bal‐GEL 79.9%; mean age 29.1 ± 38.6 (range 0–144) months; body weight 12.1 ± 10.5 (1.4–70) kg) were included in the analysis. The most frequent indications for GEL infusion were hemodynamic instability without bleeding (76.0%), crystalloids alone not being sufficient for hemodynamic stabilization (55.7%), replacement of preoperative deficit (26.0%), and significant bleeding (13.0%). Mean infused GEL volume was 13.0 ± 5.3 (2.4–37.5) ml kg−1. The total dose was affected by age, with higher doses in younger patients. After gelatin infusion, mean arterial pressure increased (mean change 8.5 ± 7.3 [95% CI: 8 to 9.1] mmHg), and the hemoglobin concentrations decreased significantly (mean change −1.1 ± 1.8 [95% CI: −1.2 to −0.9] g·dL−1). Acid–base parameters were more stable with bal‐GEL. No serious adverse drug reactions directly related to gelatin (i.e., anaphylactoid reaction, clotting disorders, and renal failure) were observed. Conclusion Moderate doses up to 20 ml kg−1 of modified fluid gelatin were infused most frequently to improve hemodynamic stability in children undergoing major pediatric surgery. The acid–base balance was more stable when gelatin in a balanced electrolyte solution was used instead of saline. No serious adverse drug reactions associated with gelatin were observed.
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