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During the past 70 years, patient safety science has evolved through four organizational frameworks known as Safety-0, Safety -1, Safety-2, and Safety-3. Their evolution reflects the realization over time that blaming people, chasing errors, fixing one-offs, and regulation would not create the desired patient safety. In Safety-0, the oldest framework, harm events arise from clinician failure; event prevention relies on better staffing, education, and basic standards. In Safety-1, used by hospitals, harm events arise from individual and/or system failures. Safety is improved through analytics, workplace culture, high reliability principles, technology, and quality improvement. Safety-2 emphasizes clinicians' adaptability to prevent harm events in an everchanging environment, using resilience engineering principles. Safety-3, used by aviation, adds system design and control elements to Safety-1 and Safety-2, deploying human factors, design-thinking, and operational control or feedback to prevent and respond to harm events. Safety-3 represents a potential way for anesthesia and perioperative care to become safer., (Copyright © 2024 American Society of Anesthesiologists. All Rights Reserved.)

Background: Unlike expired sevoflurane concentration, propofol lacks a biomarker for its brain effect site concentration, leading to dosing imprecision particularly in infants. Electroencephalography monitoring can serve as a biomarker for propofol effect site concentration, yet proprietary electroencephalography indices are not validated in infants. The authors evaluated spectral edge frequency (SEF95) as a propofol anesthesia biomarker in infants. It was hypothesized that the SEF95 targets will vary for different clinical stimuli and an inverse relationship existed between SEF95 and propofol plasma concentration., Methods: This prospective study enrolled infants (3 to 12 months) to determine the SEF95 ranges for three clinical endpoints of anesthesia (consciousness-pacifier placement, pain-electrical nerve stimulation, and intubation-laryngoscopy) and correlation between SEF95 and propofol plasma concentration at steady state. Dixon's up-down method was used to determine target SEF95 for each clinical endpoint. Centered isotonic regression determined the dose-response function of SEF95 where 50% and 90% of infants (ED50 and ED90) did not respond to the clinical endpoint. Linear mixed-effect model determined the association of propofol plasma concentration and SEF95., Results: Of 49 enrolled infants, 44 evaluable (90%) showed distinct SEF95 for endpoints: pacifier (ED50, 21.4 Hz; ED90, 19.3 Hz), electrical stimulation (ED50, 12.6 Hz; ED90, 10.4 Hz), and laryngoscopy (ED50, 8.5 Hz; ED90, 5.2 Hz). From propofol 0.5 to 6 μg/ml, a 1-Hz SEF95 increase was linearly correlated to a 0.24 (95% CI, 0.19 to 0.29; P < 0.001) μg/ml decrease in plasma propofol concentration (marginal R2 = 0.55)., Conclusions: SEF95 can be a biomarker for propofol anesthesia depth in infants, potentially improving dosing accuracy and utilization of propofol anesthesia in this population., (Copyright © 2024 American Society of Anesthesiologists. All Rights Reserved.)

Electroencephalogram (EEG) can be used to assess depth of consciousness, but interpreting EEG can be challenging, especially in neonates whose EEG undergo rapid changes during the perinatal course. EEG can be processed into quantitative EEG (QEEG), but limited data exist on the range of QEEG for normal term neonates during wakefulness and sleep, baseline information that would be useful to determine changes during sedation or anesthesia. We aimed to determine the range of QEEG in neonates during awake, active sleep and quiet sleep states, and identified the ones best at discriminating between the three states. Normal neonatal EEG from 37 to 46 weeks were analyzed and classified as awake, quiet sleep, or active sleep. After processing and artifact removal, total power, power ratio, coherence, entropy, and spectral edge frequency (SEF) 50 and 90 were calculated. Descriptive statistics were used to summarize the QEEG in each of the three states. Receiver operating characteristic (ROC) curves were used to assess discriminatory ability of QEEG. 30 neonates were analyzed. QEEG were different between awake vs asleep states, but similar between active vs quiet sleep states. Entropy beta, delta2 power %, coherence delta2, and SEF50 were best at discriminating awake vs active sleep. Entropy beta had the highest AUC-ROC ≥ 0.84. Entropy beta, entropy delta1, theta power %, and SEF50 were best at discriminating awake vs quiet sleep. All had AUC-ROC ≥ 0.78. In active sleep vs quiet sleep, theta power % had highest AUC-ROC > 0.69, lower than the other comparisons. We determined the QEEG range in healthy neonates in different states of consciousness. Entropy beta and SEF50 were best at discriminating between awake and sleep states. QEEG were not as good at discriminating between quiet and active sleep. In the future, QEEG with high discriminatory power can be combined to further improve ability to differentiate between states of consciousness., (© 2023. The Author(s), under exclusive licence to Springer Nature B.V.)

Background: Propofol-based total intravenous anesthesia is gaining popularity in pediatric anesthesia. Electroencephalogram can be used to guide propofol dosing to the individual patient to mitigate against overdosing and adverse events. However, electroencephalogram interpretation and propofol pharmacokinetics are not sufficiently taught in training programs to confidently deploy electroencephalogram-guided total intravenous anesthesia., Aims: We conducted a quality improvement project with the smart aim of increasing the percentage of electroencephalogram-guided total intravenous anesthesia cases in our main operating room from 0% to 80% over 18 months. Balancing measures were number of total intravenous anesthesia cases, emergence times, and perioperative emergency activations., Methods: The project key drivers were education, equipment, and electronic health record modifications. Plan-Do-Study-Act cycles included: (1) providing journal articles, didactic lectures, intraoperative training, and teaching documents; (2) scheduling electroencephalogram-guided total intravenous anesthesia teachers to train faculty, staff, and fellows for specific cases and to assess case-based knowledge; (3) adding age-based propofol dosing tables and electroencephalogram parameters to the electronic health record (EPIC co, Verona, WI); (4) procuring electroencephalogram monitors (Sedline, Masimo Inc). Electroencephalogram-guided total intravenous anesthesia cases and balancing measures were identified from the electronic health record. The smart aim was evaluated by statistical process control chart., Results: After the four Plan-Do-Study-Act cycles, electroencephalogram-guided total intravenous anesthesia increased from 5% to 75% and was sustained at 72% 9 months after project completion. Total intravenous anesthesia cases/mo and number of perioperative emergency activations did not change significantly from start to end of the project, while emergence time for electroencephalogram-guided total intravenous anesthesia was greater statistically but not clinically (total intravenous anesthesia without electroencephalogram [16 ± 10 min], total intravenous anesthesia with electroencephalogram [18 ± 9 min], sevoflurane [17 ± 9 min] p < .001)., Conclusion: Quality improvement methods may be deployed to adopt electroencephalogram-guided total intravenous anesthesia in a large academic pediatric anesthesia practice. Keys to success include education, in operating room case training, scheduling teachers with learners, electronic health record modifications, and electroencephalogram devices and supplies., (© 2023 John Wiley & Sons Ltd.)

Background: General anesthetics (eg, propofol and volatile anesthetics) enhance the slow-delta oscillations of the cortical electroencephalogram (EEG), which partly results from the enhancement of (γ-aminobutyric acid [GABA]) γ-aminobutyric acid-ergic (GABAergic) transmission. There is a GABAergic excitatory-inhibitory shift during postnatal development. Whether general anesthetics can enhance slow-delta oscillations in the immature brain has not yet been unequivocally determined., Methods: Perforated patch-clamp recording was used to confirm the reversal potential of GABAergic currents throughout GABAergic development in acute brain slices of neonatal rats. The power density of the electrocorticogram and the minimum alveolar concentrations (MAC) of isoflurane and/or sevoflurane were measured in P4-P21 rats. Then, the effects of bumetanide, an inhibitor of the Na + -K + -2Cl - cotransporter (NKCC1) and K + -Cl - cotransporter (KCC2) knockdown on the potency of volatile anesthetics and the power density of the EEG were determined in vivo., Results: Reversal potential of GABAergic currents were gradually hyperpolarized from P4 to P21 in cortical pyramidal neurons. Bumetanide enhanced the hypnotic effects of volatile anesthetics at P5 (for MAC LORR , isoflurane: 0.63% ± 0.07% vs 0.81% ± 0.05%, 95% confidence interval [CI], -0.257 to -0.103, P < .001; sevoflurane: 1.46% ± 0.12% vs 1.66% ± 0.09%, 95% CI, -0.319 to -0.081, P < .001); while knockdown of KCC2 weakened their hypnotic effects at P21 in rats (for MAC LORR , isoflurane: 0.58% ± 0.05% to 0.77% ± 0.20%, 95% CI, 0.013-0.357, P = .003; sevoflurane: 1.17% ± 0.04% to 1.33% ± 0.04%, 95% CI, 0.078-0.244, P < .001). For cortical EEG, slow-delta oscillations were the predominant components of the EEG spectrum in neonatal rats. Isoflurane and/or sevoflurane suppressed the power density of slow-delta oscillations rather than enhancement of it until GABAergic maturity. Enhancement of slow-delta oscillations under volatile anesthetics was simulated by preinjection of bumetanide at P5 (isoflurane: slow-delta changed ratio from -0.31 ± 0.22 to 1.57 ± 1.15, 95% CI, 0.67-3.08, P = .007; sevoflurane: slow-delta changed ratio from -0.46 ± 0.25 to 0.95 ± 0.97, 95% CI, 0.38-2.45, P = .014); and suppressed by KCC2-siRNA at P21 (isoflurane: slow-delta changed ratio from 16.13 ± 5.69 to 3.98 ± 2.35, 95% CI, -18.50 to -5.80, P = .002; sevoflurane: slow-delta changed ratio from 0.13 ± 2.82 to 3.23 ± 2.49, 95% CI, 3.02-10.79, P = .003)., Conclusions: Enhancement of cortical EEG slow-delta oscillations by volatile anesthetics may require mature GABAergic inhibitory transmission during neonatal development., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2023 International Anesthesia Research Society.)

Background: Propofol total intravenous anesthesia (TIVA) is increasingly popular in pediatric anesthesia, but education on its use is variable and over-dosage adverse events are not uncommon. Recent work suggests that electroencephalogram (EEG) parameters can guide propofol dosing in the pediatric population. This education quality improvement project aimed to implement a standardized EEG TIVA training program over 12 months in a large pediatric anesthesia division., Methods: The division consisted of 63 faculty, 11 clinical fellows, 32 residents, and 28 nurse anesthetists at the Children's Hospital of Philadelphia. The program was assessed for effectiveness (a significant improvement in EEG knowledge scores), scalability (training 50% of fellows and staff), and sustainability (recurring EEG lectures for 80% of rotating residents and 100% of new fellows and staff). The key drivers included educational content development (lectures, articles, and hand-outs), training a cohort of EEG TIVA trainers, intraoperative teaching (teaching points and dosing tables), decision support tools (algorithms and anesthesia electronic record pop-ups), and knowledge tests (written exam and verbal quiz during cases)., Results: Over 12 months, 78.5% of the division (62/79) completed EEG training and test scores improved (mean score 38% before training vs 59% after training, p < .001). Didactic lectures were given to 100% of the fellows, 100% (11/11) of new staff, and 80% (4/5 blocks) of rotating residents., Conclusion: This quality improvement education project successfully trained pediatric anesthesia faculty, staff, residents, and fellows in EEG-guided TIVA. The training program was effective, scalable, and sustainable over time for newly hired faculty staff and rotating fellows and residents., (© 2022 John Wiley & Sons Ltd.)

Background: Intraoperative isoelectric electroencephalography (EEG) has been associated with hypotension and postoperative delirium in adults. This international prospective observational study sought to determine the prevalence of isoelectric EEG in young children during anesthesia. The authors hypothesized that the prevalence of isoelectric events would be common worldwide and associated with certain anesthetic practices and intraoperative hypotension., Methods: Fifteen hospitals enrolled patients age 36 months or younger for surgery using sevoflurane or propofol anesthetic. Frontal four-channel EEG was recorded for isoelectric events. Demographics, anesthetic, emergence behavior, and Pediatric Quality of Life variables were analyzed for association with isoelectric events., Results: Isoelectric events occurred in 32% (206 of 648) of patients, varied significantly among sites (9 to 88%), and were most prevalent during pre-incision (117 of 628; 19%) and surgical maintenance (117 of 643; 18%). Isoelectric events were more likely with infants younger than 3 months (odds ratio, 4.4; 95% CI, 2.57 to 7.4; P < 0.001), endotracheal tube use (odds ratio, 1.78; 95% CI, 1.16 to 2.73; P = 0.008), and propofol bolus for airway placement after sevoflurane induction (odds ratio, 2.92; 95% CI, 1.78 to 4.8; P < 0.001), and less likely with use of muscle relaxant for intubation (odds ratio, 0.67; 95% CI, 0.46 to 0.99; P = 0.046]. Expired sevoflurane was higher in patients with isoelectric events during preincision (mean difference, 0.2%; 95% CI, 0.1 to 0.4; P = 0.005) and surgical maintenance (mean difference, 0.2%; 95% CI, 0.1 to 0.3; P = 0.002). Isoelectric events were associated with moderate (8 of 12, 67%) and severe hypotension (11 of 18, 61%) during preincision (odds ratio, 4.6; 95% CI, 1.30 to 16.1; P = 0.018) (odds ratio, 3.54; 95% CI, 1.27 to 9.9; P = 0.015) and surgical maintenance (odds ratio, 3.64; 95% CI, 1.71 to 7.8; P = 0.001) (odds ratio, 7.1; 95% CI, 1.78 to 28.1; P = 0.005), and lower Pediatric Quality of Life scores at baseline in patients 0 to 12 months (median of differences, -3.5; 95% CI, -6.2 to -0.7; P = 0.008) and 25 to 36 months (median of differences, -6.3; 95% CI, -10.4 to -2.1; P = 0.003) and 30-day follow-up in 0 to 12 months (median of differences, -2.8; 95% CI, -4.9 to 0; P = 0.036). Isoelectric events were not associated with emergence behavior or anesthetic (sevoflurane vs. propofol)., Conclusions: Isoelectric events were common worldwide in young children during anesthesia and associated with age, specific anesthetic practices, and intraoperative hypotension., (Copyright © 2022, the American Society of Anesthesiologists. All Rights Reserved.)

Background: Failure to complete surgery within the scheduled timeframe impairs operating room efficiency leading to patient dissatisfaction and unplanned labor costs. We sought to improve timely completion (within 30 min of scheduled time) of first-case spine fusion surgery (for idiopathic scoliosis) from a baseline of 25%-80% over 12 months. We also targeted timely completion of perioperative stages within predetermined target completion times., Methods: The project was conducted in three overlapping phases over 16 months. A simplified process map outlining five sequential perioperative stages, preintervention baselines (N = 24) and time targets were defined. A multidisciplinary team conducted a series of tests of change addressing the aims. The key drivers included effective scheduling, team communications, family engagement, data collection veracity, standardized pathways, and situational awareness. Data collected by an independent data collector and from electronic medical records were analyzed using control charts and statistical process control methods., Results: Post-intervention, timely case completion increased from 25% to 68% (N = 49) (95% CI 15.1-62.7), (p = 0.003) and was sustained (N = 14). Implementation of prediction model for case-scheduling decreased difference between scheduled and actual case end-time (33 vs. 53 min [baseline]) and variance [lower/upper control limits ([-26, 51] vs. [-109, 216] min [baseline]). Average start time delay decreased from 6 to 2 min and on-time surgical starts improved from 50% to 70% (95% CI 3.2-41.6%). Timely completion increased for anesthesia induction (60% to 85%), surgical procedure (26% to 48%) and emergence from anesthesia (44% to 80%) but not for intraoperative patient preparation (30% to 25%) perioperative stages. Families reported satisfaction with preoperative processes (N = 14), and no untoward intraoperative safety events occurred., Conclusions: Application of QI methodology reduced time variation of several tasks and improved timely completion of spine surgery. Beyond the study period, sustained team behavior, adaptive changes, and vigilant monitoring are imperative for continued success., (© 2022 John Wiley & Sons Ltd.)

Introduction: Pain assessment is challenging in neonates. Behavioral and physiological pain scales do not assess neocortical nociception, essential to pain encoding and central pain pathway development. Functional near-infrared spectroscopy (fNIRS) can assess neocortical activation to noxious stimuli from changes in oxy-(HbO) and total-hemoglobin concentrations (HbT). This study aims to assess fNIRS nociceptive functional activation in the prefrontal cortex of neonates undergoing circumcision through changes in HbO and HbT, and the correlation between changes in fNIRS and Neonatal Infant Pain Scale (NIPS), a behavioral pain assessment scale., Methods: In healthy term neonates, HbO, HbT, and NIPS were recorded during sequential circumcision events 1-Prep before local anesthetic injection; 2-Local anesthetic injection; 3-Prep before incision; 4-Oral sucrose; 5-Incision; 6-Gomco (hemostatic device) attached; 7-Gomco twisted on; and 8-Gomco removed. fNIRS and NIPS changes after each event were assessed with Wilcoxon signed-rank test and summarized as median and interquartile range (IQR). Changes in fNIRS vs. NIPS were correlated with Spearman coefficient., Results: In 31 neonates fNIRS increased (median [IQR] µmol/L) with noxious events: Local injection (HbO: 1.1 [0.5, 3.1], p < .001; HbT: 2.3 [0.2, 7.6], p < .001), Gomco attached (HbO: 0.7 [0.1, 1.7], p = .002; HbT: 0.7 [-0.2, 2.9], p = .02), and Gomco twisted on (HbO: 0.5 [-0.2, 1.7], p = .03; HbT: 0.8 [-0.1, 3.3], p = .02). fNIRS decreased with non-noxious event: Prep before incision (HbO: -0.6 [-1.2, -0.2] p < .001; HbT: -1 [-1.8, -0.4], p < .001). Local anesthetic attenuated fNIRS increases to subsequent sharp stimuli. NIPS increased with subsequent sharp stimuli despite local anesthetic. Although fNIRS and NIPS changed in the same direction, there was not a strong correlation between them., Conclusions: During neonatal circumcision, changes in fNIRS differed between different types of painful stimuli, which was not the case for NIPS, suggesting that fNIRS may complement NIPS to assess the quality of pain., (© 2021 John Wiley & Sons Ltd.)

Safe and effective techniques for propofol total intravenous anesthesia (TIVA) in infants are not well imbedded into clinical practice, resulting in practitioner unfamiliarity and potential for over- and under-dosing. In this education article, we describe our approach to TIVA dosing in infants and toddlers (birth to 36 months) which combines the use of pharmacokinetic models with EEG multi-parameter analysis. Pharmacokinetic models describe propofol and remifentanil effect site concentrations (Ce) over time in different age groups for a given dosing regimen. These models display substantial biological variability between individuals within age groups, impeding their application to clinical practice. Nevertheless, they reveal that younger infants require a higher propofol loading dose, a lower propofol maintenance dose, and a higher remifentanil dose compared with older infants. Proprietary EEG indices (eg, Bispectral Index) can serve as a biomarker of propofol Ce in adults and children to guide dosing to the individual patient; however, they are not recommended for infants as their validity remains uncertain this population. In our experience, EEG waveforms and processed parameters can reflect propofol Ce in infants, reflected by spectral edge frequency (SEF), density spectral array (DSA), and waveform patterns. In our practice, we use a "lookup table" of age-based dosing regimens or target-controlled infusion (TCI) based on the pharmacokinetic models to deliver a target propofol Ce and co-administer remifentanil and/or regional technique for analgesia. We analyze Electroencephalogram (EEG) waveforms, SEF, and DSA to adjust the propofol dose or TCI target concentration to the individual infant. EEG analysis mitigates against biological variability inherent in the pharmacokinetic models and has improved our experience with TIVA for infants., (© 2020 John Wiley & Sons Ltd.)

Sevoflurane and propofol-based anesthetics are dosed according to vital signs, movement, and expired sevoflurane concentrations, which do not assess the anesthetic state of the brain and, therefore, risk underdose and overdose. Electroencephalography (EEG) measures cortical brain activity and can assess hypnotic depth, a key component of the anesthetic state. Application of sevoflurane and propofol pharmacology along with EEG parameters can more precisely guide dosing to achieve the desired anesthetic state for an individual pediatric patient. This article reviews the principles underlying EEG use for sevoflurane and propofol dosing in pediatric anesthesia and offers case examples to illustrate their use in individual patients., Competing Interests: Disclosure The authors have nothing to disclose., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: In infants and young children, anesthetic dosing is based on population pharmacokinetics and patient hemodynamics not on patient-specific brain activity. Electroencephalography (EEG) provides insight into brain activity during anesthesia. The primary goal of this prospective observational pilot study was to assess the prevalence of isoelectric EEG events-a sign of deep anesthesia-in infants and young children undergoing general anesthesia using sevoflurane or propofol infusion for maintenance., Methods: Children 0-37 months of age requiring general anesthesia for surgery excluding cardiac, intracranial, and emergency cases were enrolled by age: 0-3, 4-6, 7-12, 13-18, and 19-37 months. Anesthesia was maintained with sevoflurane or propofol infusion. EEG was recorded from induction to extubation. Isoelectric EEG events (amplitude <20 µV, lasting ≥2 seconds) were characterized by occurrence, number, duration, and percent of isoelectric EEG time over anesthetic time. Associations with patient demographics, anesthetic, and surgical factors were determined., Results: Isoelectric events were observed in 63% (32/51) (95% confidence interval [CI], 49-76) of patients. The median (interquartile range [IQR]) number of isoelectric events per patient was 3 (0-31), cumulative isoelectric time per patient was 12 seconds (0-142 seconds), isoelectric time per event was 3 seconds (0-4 seconds), and percent of total isoelectric over anesthetic time was 0.1% (0%-2.2%). The greatest proportion of isoelectric events occurred between induction and incision. Isoelectric events were associated with higher American Society of Anesthesiologists (ASA) physical status, propofol bolus, endotracheal tube use, and lower arterial pressure during surgical phase., Conclusions: Isoelectric EEG events were common in infants and young children undergoing sevoflurane or propofol anesthesia. Although the clinical significance of these events remains uncertain, they suggest that dosing based on population pharmacokinetics and patient hemodynamics is often associated with unnecessary deep anesthesia during surgical procedures.

This Statistical Analysis Plan details the statistical procedures to be applied for the analysis of data for the multicenter electroencephalography study. It consists of a basic description of the study in broad terms and separate sections that detail the methods of different aspects of the statistical analysis, summarized under the following headings (a) Background; (b) Definitions of protocol violations; (c) Definitions of objectives and other terms; (d) Variables for analyses; (e) Handling of missing data and study bias; (f) Statistical analysis of the primary and secondary study outcomes; (g) Reporting of study results; and (h) References. It serves as a template for researchers interested in writing a Statistical Analysis Plan., (© 2019 John Wiley & Sons Ltd.)

Biomedical research has been struck with the problem of study findings that are not reproducible. With the advent of large databases and powerful statistical software, it has become easier to find associations and form conclusions from data without forming an a-priori hypothesis. This approach may yield associations without clinical relevance, false positive findings, or biased results due to "fishing" for the desired results. To improve reproducibility, transparency, and validity among clinical trials, the National Institute of Health recently updated its grant application requirements, which mandates registration of clinical trials and submission of the original statistical analysis plan (SAP) along with the research protocol. Many leading journals also require the SAP as part of the submission package. The goal of this article and the companion article detailing the SAP of an actual research study is to provide a practical guide on writing an effective SAP. We describe the what, why, when, where, and who of a SAP, and highlight the key contents of the SAP., (© 2019 John Wiley & Sons Ltd.)

Background: Near-infrared spectroscopy can interrogate functional optical signal changes in regional brain oxygenation and blood volume to nociception analogous to functional magnetic resonance imaging., Aims: This exploratory study aimed to characterize the near-infrared spectroscopy signals for oxy-, deoxy-, and total hemoglobin from the brain in response to nociceptive stimulation of varying intensity and duration, and after analgesic and neuromuscular paralytic in a pediatric population., Methods: We enrolled children 6 months-21 years during propofol sedation before surgery. The near-infrared spectroscopy sensor was placed on the forehead and nociception was produced from an electrical current applied to the wrist. We determined the near-infrared spectroscopy signal response to increasing current intensity and duration, and after fentanyl, sevoflurane, and neuromuscular paralytic. Heart rate and arm movement during electrical stimulation was also recorded. The near-infrared spectroscopy signals for oxy-, deoxy-, and total hemoglobin were calculated as optical density*time (area under curve)., Results: During electrical stimulation, nociception was evident: tachycardia and arm withdrawal was observed that disappeared after fentanyl and sevoflurane, whereas after paralytic, tachycardia persisted while arm withdrawal disappeared. The near-infrared spectroscopy signals for oxy-, deoxy-, and total hemoglobin increased during stimulation and decreased after stimulation; the areas under the curves were greater for stimulations 30 mA vs 15 mA (13.9 [5.6-22.2], P = .0021; 5.6 [0.8-10.5], P = .0254, and 19.8 [10.5-29.1], P = .0002 for HbO 2 , Hb, and Hb T , respectively), 50 Hz vs 1 Hz (17.2 [5.8-28.6], P = .0046; 7.5 [0.7-14.3], P = .0314, and 21.9 [4.2-39.6], P = .0177 for HbO 2 , Hb, and Hb T , respectively) and 45 seconds vs 15 seconds (16.3 [3.4-29.2], P = .0188 and 22.0 [7.5-36.5], P = .0075 for HbO 2 and Hb T , respectively); the areas under the curves were attenuated by analgesics but not by paralytic., Conclusion: Near-infrared spectroscopy detected functional activation to nociception in a broad pediatric population. The near-infrared spectroscopy response appears to represent nociceptive processing because the signals increased with noxious stimulus intensity and duration, and were blocked by analgesics but not paralytics., (© 2017 John Wiley & Sons Ltd.)

Background: General anesthesia during infancy is associated with neurocognitive abnormalities. Potential mechanisms include anesthetic neurotoxicity, surgical disease, and cerebral hypoxia-ischemia. This study aimed to determine the incidence of low cerebral oxygenation and associated factors during general anesthesia in infants., Methods: This multicenter study enrolled 453 infants aged less than 6 months having general anesthesia for 30 min or more. Regional cerebral oxygenation was measured by near-infrared spectroscopy. We defined events (more than 3 min) for low cerebral oxygenation as mild (60 to 69% or 11 to 20% below baseline), moderate (50 to 59% or 21 to 30% below baseline), or severe (less than 50% or more than 30% below baseline); for low mean arterial pressure as mild (36 to 45 mmHg), moderate (26 to 35 mmHg), or severe (less than 25 mmHg); and low pulse oximetry saturation as mild (80 to 89%), moderate (70 to 79%), or severe (less than 70%)., Results: The incidences of mild, moderate, and severe low cerebral oxygenation were 43%, 11%, and 2%, respectively; mild, moderate, and severe low mean arterial pressure were 62%, 36%, and 13%, respectively; and mild, moderate, and severe low arterial saturation were 15%, 4%, and 2%, respectively. Severe low oxygen saturation measured by pulse oximetry was associated with mild and moderate cerebral desaturation; American Society of Anesthesiology Physical Status III or IV versus I was associated with moderate cerebral desaturation. Severe low cerebral saturation events were too infrequent to analyze., Conclusions: Mild and moderate low cerebral saturation occurred frequently, whereas severe low cerebral saturation was uncommon. Low mean arterial pressure was common and not well associated with low cerebral saturation. Unrecognized severe desaturation lasting 3 min or longer in infants seems unlikely to explain the subsequent development of neurocognitive abnormalities.

Background: In children, postoperative respiratory rate (RR) monitoring by transthoracic impedance (TI), capnography, and manual counting has limitations. The rainbow acoustic monitor (RAM) measures continuous RR noninvasively by a different methodology. Our primary aim was to compare the degree of agreement and accuracy of RR measurements as determined by RAM and TI to that of manual counting. Secondary aims include tolerance and analysis of alarm events., Methods: Sixty-two children (2-16 years old) were admitted after tonsillectomy or receiving postoperative patient/parental-controlled analgesia. RR was measured at regular intervals by RAM, TI, and manual count. Each TI or RAM alarm resulted in a clinical evaluation to categorize as a true or false alarm. To assess accuracy and degree of agreement of RR measured by RAM or TI compared with manual counting, a Bland-Altman analysis was utilized showing the average difference and the limits of agreement. Sensitivity and specificity of RR alarms by TI and RAM are presented., Results: Fifty-eight posttonsillectomy children and 4 patient/parental-controlled analgesia users aged 6.5 ± 3.4 years and weighting 35.3 ± 22.7 kg (body mass index percentile 76.6 ± 30.8) were included. The average monitoring time per patient was 15.9 ± 4.8 hours. RAM was tolerated 87% of the total monitoring time. The manual RR count was significantly different from TI (P = .007) with an average difference ± SD of 1.39 ± 10.6 but were not significantly different from RAM (P = .81) with an average difference ± SD of 0.17 ± 6.8. The proportion of time when RR measurements differed by ≥4 breaths was 22% by TI and was 11% by RAM. Overall, 276 alarms were detected (mean alarms/patient = 4.5). The mean number of alarms per patient were 1.58 ± 2.49 and 2.87 ± 4.32 for RAM and TI, respectively. The mean number of false alarms was 0.18 ± 0.71 for RAM and 1.00 ± 2.78 for TI. The RAM was found to have 46.6% sensitivity (95% confidence interval [CI], 0.29-0.64), 95.9% specificity (95% CI, 0.90-1.00), 88.9% positive predictive value (95% CI, 0.73-1.00), and 72.1% negative predictive value (95% CI, 0.61-0.84), whereas the TI monitor had 68.5% sensitivity (95% CI, 0.53-0.84), 72.0% specificity (95% CI, 0.60-0.84), 59.0% positive (95% CI, 0.44-0.74), and 79.5% negative predictive value (95% CI, 0.69-0.90)., Conclusions: In children at risk of postoperative respiratory depression, RR assessment by RAM was not different to manual counting. RAM was well tolerated, had a lower incidence of false alarms, and had better specificity and positive predictive value than TI. Rigorous evaluation of the negative predictive value is essential to determine the role of postoperative respiratory monitoring with RAM.

Background: Rainbow Pulse CO-Oximetry technology (Masimo Corporation, Irvine, CA) provides continuous and noninvasive measurement of arterial hemoglobin concentration (SpHb). We assessed the trending and accuracy of SpHb by this innovative monitoring compared with Hb concentration obtained with conventional laboratory techniques (Hb) in children undergoing surgical procedures with potential for substantial blood loss., Methods: Hb concentrations were recorded from Pulse CO-Oximetry and a conventional hematology analyzer. Regression analysis and 4-quadrant plot were used to evaluate the trending for changes in SpHb and Hb measurements (ΔSpHb and ΔHb). Bias, precision, and limits of agreement of SpHb and of in vivo adjusted SpHb (SpHb - first bias to HB) compared with Hb were calculated., Results: One hundred fifty-eight SpHb-Hb data pairs and 105 delta pairs (ΔSpHb and ΔHb) from 46 patients aged 2 months to 17 years with Hb ranging from 16.7 to 7.9 g/dL were collected. To evaluate trending, the delta pairs (ΔSpHb and ΔHb) were plotted, which revealed a positive correlation (ΔSpHb = 0.022 + 0.76ΔHb) with correlation coefficient r = 0.76, 95% CI [confidence interval] = 0.57-0.86. The bias and precision of SpHb to Hb and in vivo adjusted SpHb were 0.4 ± 1.3 g/dL and 0.1 ± 1.2 g/dL, respectively; the limits of agreement were -2.0 to 3.2 g/dL before in vivo adjustment and -2.4 to 2.2 g/dL after in vivo adjustment (P value = 0.04). The mean percent bias (from the reference Hb concentration) decreased from 4.1% ± 11.9% to 0.7% ± 11.3% (P value = 0.01). No drift in bias over time was observed during the study procedure. Of patient demographic and physiological factors tested for correlation with the SpHb, only perfusion index at sensor site showed a weak correlation., Conclusions: The accuracy of SpHb in children with normal Hb and mild anemia is similar to that previously reported in adults and is independent of patient demographic and physiological states except for a weak correlation with perfusion index. The trending of SpHb and Hb in children with normal Hb and mild anemia showed a positive correlation. Further studies are necessary in children with moderate and severe anemia.

Background: As pediatric anesthesia has become safer over the years, it is difficult to quantify these safety advances at any 1 institution. Safety analytics (SA) and quality improvement (QI) are used to study and achieve high levels of safety in nonhealth care industries. We describe the development of a multiinstitutional program in the United States, known as Wake-Up Safe (WUS), to determine the rate of serious adverse events (SAE) in pediatric anesthesia and to apply SA and QI in the pediatric anesthesia departments to decrease the SAE rate., Methods: QI was used to design and implement WUS in 2008. The key drivers in the design were an organizational structure; an information system for the SAE; SA to characterize the SAE; QI to imbed high-reliability care; communications to disseminate the learnings; and engaged leadership in each department. Interventions for the key drivers, included Participation Agreements, Patient Safety Organization designation, IRB approval, Data Management Co., membership fee, SAE standard templates, SA and QI workshops, and department leadership meetings., Results: WUS has 19 institutions, 39 member anesthesiologists, 734 SAE, and 736,365 anesthetics as of March, 2013. The initial members joined at year 1, and initial SAE were recorded by year 2. The SAE rate is 1.4 per 1000 anesthetics. Of SAE, respiratory was most common, followed by cardiac arrest, care escalation, and cardiovascular, collectively 76% of SAE. In care escalation, medication errors and equipment dysfunction were 89%. Of member anesthesiologists, 70% were trained in SA and QI by March 2013; virtually, none had SA and QI expertise before joining WUS., Conclusion: WUS documented the incidence and types of SAE nationally in pediatric anesthesiology. Education and application of QI and SA in anesthesia departments are key strategies to improve perioperative safety by WUS.

Purpose of Review: Cognitive aids are tangible or intangible instruments that guide users in decision-making and in the completion of a complex series of tasks. Common examples include mnemonics, checklists, and algorithms. Cognitive aids constitute very effective approaches to achieve well tolerated, high quality healthcare because they promote highly reliable processes that reduce the likelihood of failure. This review describes recent advances in quality improvement for pediatric anesthesiology with emphasis on application of cognitive aids to impact patient safety and outcomes., Recent Findings: Quality improvement encourages the examination of systems to create stable processes and ultimately high-value care. Quality improvement initiatives in pediatric anesthesiology have been shown to improve outcomes and the delivery of efficient and effective care at many institutions. The use of checklists, in particular, improves adherence to evidence-based care in crisis situations, decreases catheter-associated bloodstream infections, reduces blood product utilization, and improves communication during the patient handoff process. Use of this simple tool has been associated with decreased morbidity, fewer medical errors, improved provider satisfaction, and decreased mortality in nonanesthesia disciplines as well., Summary: Successful quality improvement initiatives utilize cognitive aids such as checklists and have been shown to optimize pediatric patient experience and anesthesia outcomes and reduce perioperative complications.

Objective: The primary outcome of this study was to examine the cost-effectiveness of the intraoperative combination of intravenous (IV) acetaminophen and IV opioids, versus IV opioids alone, as a part of an inhalational anesthetic technique for tonsillectomy in children., Methods: We used Decision Maker® software to construct and analyze a decision analytic model. Base-case and sensitivity analyses were performed. We studied the use of rescue analgesics in the postanesthesia care unit (PACU), adverse effects of acetaminophen and opioids, and costs associated with adverse effects. Costs were in 2013 US dollars, and effectiveness was measured as frequency of avoiding the need for rescue analgesics. Direct medical costs included medication, equipment, supplies, and labor associated with the treatment of adverse events from pain medications. Medication costs assumed single-dose vials., Results: In the base case, IV acetaminophen in combination with opioids was both less costly ($17.12) and more effective (3.3% fewer rescue events). In sensitivity analyses, the combination strategy remained cost-effective as long as the frequency of rescue analgesic administration was less than that in the opioid-alone strategy. Although medication costs of the combination strategy were higher, the overall costs were less than the competing strategy due to reduced adverse effects and reduced time spent in PACU., Conclusions: The routine use of IV acetaminophen as an adjuvant to IV opioids for tonsillectomy with or without adenoidectomy in children aged <17 years should be considered as a means to reduce the need for rescue analgesia and in turn reduce costs., (© 2014 John Wiley & Sons Ltd.)

Organizational culture underlies every improvement strategy; without a strong culture, a change, even if initially successful, is short lived. Changing culture and improving quality require commitment of leadership, and leaders must play an active and visible role to articulate the vision and create the proper environment. Quality-improvement projects require a consistent framework for outlining a process, identifying problems, and testing, evaluating, and implementing changes. Wake Up Safe is a patient safety organization that strives to use quality improvement to make anesthesia care safer. Root cause analysis is a methodology in safety analytics based on a sequence of events model of safety., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Background: Rainbow acoustic monitoring (RRa) utilizes acoustic technology to continuously and noninvasively determine respiratory rate from an adhesive sensor located on the neck., Objective: We sought to validate the accuracy of RRa, by comparing it to capnography, impedance pneumography, and to a reference method of counting breaths in postsurgical children., Methods: Continuous respiration rate data were recorded from RRa and capnography. In a subset of patients, intermittent respiration rate from thoracic impedance pneumography was also recorded. The reference method, counted respiratory rate by the retrospective analysis of the RRa, and capnographic waveforms while listening to recorded breath sounds were used to compare respiration rate of both capnography and RRa. Bias, precision, and limits of agreement of RRa compared with capnography and RRa and capnography compared with the reference method were calculated. Tolerance and reliability to the acoustic sensor and nasal cannula were also assessed., Results: Thirty-nine of 40 patients (97.5%) demonstrated good tolerance of the acoustic sensor, whereas 25 of 40 patients (62.5%) demonstrated good tolerance of the nasal cannula. Intermittent thoracic impedance produced erroneous respiratory rates (>50 b·min(-1) from the other methods) on 47% of occasions. The bias ± SD and limits of agreement were -0.30 ± 3.5 b·min(-1) and -7.3 to 6.6 b·min(-1) for RRa compared with capnography; -0.1 ± 2.5 b·min(-1) and -5.0 to 5.0 b·min(-1) for RRa compared with the reference method; and 0.2 ± 3.4 b·min(-1) and -6.8 to 6.7 b·min(-1) for capnography compared with the reference method., Conclusions: When compared to nasal capnography, RRa showed good agreement and similar accuracy and precision but was better tolerated in postsurgical pediatric patients., (© 2013 John Wiley & Sons Ltd.)

Background and Objective: In multicase pediatric ear, nose, and throat operating rooms (ORs), brief delays in early case start times often produce a cascading effect of lengthy delays by the end of the day and can often lead to patient, family, and staff dissatisfaction and increased labor costs due to unplanned overtime. We sought to improve actual end of day relative to scheduled end of day from 40% to 60%., Methods: Key drivers of the process included case scheduling, ordering of sedative medications, and nurse availability in the post anesthesia care unit to receive the patient from the anesthesia provider. A multidisciplinary team conducted a series of tests of change addressing the various key drivers. Data were collected by using an independent, impartial data collector as well as being extracted from the hospital information technology system. Data were analyzed by using control charts and statistical process control methods., Results: The percentage of ORs ending on time increased from 40% to 60%. Appropriate scheduling of complex cases increased from 10% to 87%, and accurate scheduling of case duration improved from 21% to 48%. Timely premedication increased from 55% to 90% and immediate availability of a nurse in the postanesthesia care unit from 68% to.90%., Conclusions: By applying quality-improvement methods, significant improvements were made in a multicase pediatric ear, nose, and throat OR. The impact can be significant by reducing wait times for patients, as well as staff overtime for the institution.

Although the case for quality in hospitals is compelling, doctors are often uncertain how to achieve it. This article forms the third and final part of a series providing practical guidance on getting started with a first quality improvement project. Introduction.

Background: Cerebral hypoxia-ischemia remains a complication in children with congenital heart disease. Near-infrared spectroscopy can be utilized at the bedside to detect cerebral hypoxia-ischemia. This study aimed to calibrate and validate an advanced technology near-infrared cerebral oximeter for use in children with congenital heart disease., Methods: After institutional review board approval and parental consent, 100 children less than 12 years and less than 40 kg were enrolled. Phase I (calibration) measured arterial and jugular venous saturation (SaO(2), SjO(2)) by co-oximetry simultaneously with device signals to calibrate an algorithm to determine regional cerebral saturation against a weighted average cerebral saturation (0.7 SjO(2) + 0.3 SaO(2)). Phase II (validation) evaluated regional cerebral saturation from the algorithm against the weighted average cerebral saturation by correlation, bias, precision, and A(Root Mean Square) assessed by linear regression and Bland-Altman analysis., Results: Of 100 patients, 86 were evaluable consisting of 7 neonates, 44 infants, and 35 children of whom 55% were female, 79% Caucasian, and 41% with cyanotic disease. The SaO(2) and regional cerebral saturation ranged from 34% to 100% and 34% to 91%, respectively. There were no significant differences in subject characteristics between phases. For the entire cohort, A(RMS), bias, precision, and correlation coefficient were 5.4%, 0.5%, 5.39%, and 0.88, respectively. Age, skin color, and hematocrit did not affect these values., Conclusions: This cerebral oximeter accurately measures the absolute value of cerebral saturation in children over a wide range of oxygenation and subject characteristics, offering advantages in assessment of cerebral hypoxia-ischemia in congenital heart disease., (Copyright © 2012 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Fetal IM injection of fentanyl is frequently performed during ex utero intrapartum therapy (EXIT procedure). We quantified the concentration of fentanyl in umbilical vein blood. Thirteen samples from 13 subjects were analyzed. Medians and ranges are reported as follows. Weight of the newborn at delivery was 3000 g (2020-3715 g). The dose of fentanyl was 60 μg (45-65 μg). The time between IM administration of fentanyl and collection of the sample was 37 minutes (5-86 minutes). Fentanyl was detected in all of the samples, with a median serum concentration of 14.0 ng/mL (4.3-64.0 ng/mL).

Significant advances in perinatal and neonatal medicine over the last 20 years and the recent emergence of fetal surgery has resulted in anesthesia providers caring for a growing number of infants born at the margin of viability. Anesthetic management in this patient population has to take into consideration the immature function of many vital organ systems as well as the effects of the underlying disease processes, which can frequently lead to severe physiological derangements. Accordingly, premature infants presenting for major surgeries early in life can represent a significant anesthetic challenge. However, even with advanced anesthetic and surgical management and optimal intensive care, extremely premature infants face substantial postoperative morbidity and mortality, as well as prolonged hospital courses. In this article, we will discuss the following questions: How far have we come in improving outcomes of extreme prematurity? And what will the future medical and societal challenges be, as we continue to redefine the limits of viability?, (© 2011 Blackwell Publishing Ltd.)

Objective: To lower the incidence and severity of fetal cardiovascular depression during maternal fetal surgery under general anesthesia., Aim: We hypothesized that supplemental intravenous anesthesia (SIVA) with propofol and remifentanil would lower the need for high-dose inhalational anesthesia and provide adequate maternal depth of anesthesia and uterine relaxation. SIVA technique would minimize prolonged fetal exposure to deep inhalational anesthetics and significant intraoperative fetal cardiovascular depression., Background: Fetal hypoxia and significant fetal hemodynamic changes occur during open fetal surgery because of the challenges such as surgical manipulation, hysterotomy, uterine contractions, and effects of anesthetic drugs. Tocolysis, a vital component of fetal surgery, is usually achieved using volatile anesthetic agents. High concentrations of volatile agents required to provide an appropriate degree of uterine relaxation may cause maternal hypotension and placental hypoperfusion, as well as direct fetal cardiovascular depression., Methods: We reviewed medical records of 39 patients who presented for ex utero intrapartum treatment and mid-gestation open fetal surgery between April 2004 and March 2009. Out of 39 patients, three were excluded because of the lack of echocardiographic data; 18 patients received high-concentration desflurane anesthesia and 18 patients had SIVA with desflurane for uterine relaxation. We analyzed the following data: demographics, fetal medical condition, anesthetic drugs, concentration and duration of desflurane, maternal arterial blood pressure, intraoperative fetal echocardiogram, presence of fetal bradycardia, and need for intraoperative fetal resuscitation., Results: Adequate uterine relaxation was achieved with about 1.5 MAC of desflurane in the SIVA group compared to about 2.5 MAC in the desflurane only anesthesia group (P = 0.0001). More fetuses in the high-dose desflurane group compared to the SIVA group developed moderate-severe left ventricular systolic dysfunction over time intraoperatively (P = 0.02). 61% of fetuses in the high-dose desflurane group received fetal resuscitative interventions compared to 26% of fetuses in the SIVA group (P = 0.0489)., Conclusion: SIVA as described provides adequate maternal anesthesia and uterine relaxation, and it allows for decreased use of desflurane during open fetal surgery. Decreased use of desflurane may better preserve fetal cardiac function.