Analysis of the factors contributing to residual weakness after sugammadex administration in pediatric patients under 2 years of age.

BACKGROUND: Sugammadex reverses the neuromuscular blockade induced by rocuronium and vecuronium and is approved by the U.S. Food and Drug Administration for use in patients aged over 2 years. There is, however, a paucity of data regarding its dosing profile in infants and children younger than 2 years. AIMS: The aim of this study was to assess the risk of recurarization, or re-paralysis, in children under 2 years of age to increase awareness on the importance of appropriate neuromuscular blocked monitoring and reversal. METHODS: All patients aged ≤24 months who underwent an operative procedure at a tertiary medical center between January 1, 2018, and December 31, 2021, and received both rocuronium for neuromuscular blockade and sugammadex for neuromuscular blockade reversal, were identified in the electronic medical record. Patients were excluded from analysis if they (1) received vecuronium, cisatracurium, atracurium, or succinylcholine for neuromuscular blockade, (2) received neostigmine for reversal, or (3) underwent more than one operation within 24 h. We performed a survival analysis of sugammadex redose using a Cox proportional hazards model. RESULTS: We reviewed 2923 records. Sugammadex was redosed in 123 (4.2%) cases. The median [IQR] time to redose was 7 [4-17] min, and the median [IQR] amount of redose administered was 2.74 [1.96-3.99] mg/kg. Increasing patient age (p < .01) and weight (p < .01) were associated with reduced hazard rate of sugammadex redose. For a patient of median weight, increasing age from 3 to 13 months was associated with a 53% risk reduction (HR: 0.47; 95% CI: 0.24-0.91). For a patient of median age, increasing weight from 4.7 to 9.2 kg was associated with 41% risk reduction (HR: 0.59; 95% CI: 0.32-1.07). We failed to detect any other associations. CONCLUSIONS: In this single-center, retrospective cohort study of pediatric surgery patients, there was an association between the hazard of sugammadex redose with both increased age and weight.

Understanding Patient and Clinician Reported Nonroutine Events in Ambulatory Surgery.

OBJECTIVE: Nonroutine events (NREs, i.e., deviations from optimal care) can identify care process deficiencies and safety risks. Nonroutine events reported by clinicians have been shown to identify systems failures, but this methodology fails to capture the patient perspective. The objective of this prospective observational study is to understand the incidence and nature of patient- and clinician-reported NREs in ambulatory surgery. METHODS: We interviewed patients about NREs that occurred during their perioperative care using a structured interview tool before discharge and in a 7-day follow-up call. Concurrently, we interviewed the clinicians caring for these patients immediately postoperatively to collect NREs. We trained 2 experienced clinicians and 2 patients to assess and code each reported NRE for type, theme, severity, and likelihood of reoccurrence (i.e., likelihood that the same event would occur for another patient). RESULTS: One hundred one of 145 ambulatory surgery cases (70%) contained at least one NRE. Overall, 214 NREs were reported-88 by patients and 126 by clinicians. Cases containing clinician-reported NREs were associated with increased patient body mass index ( P = 0.023) and lower postcase patient ratings of being treated with respect ( P = 0.032). Cases containing patient-reported NREs were associated with longer case duration ( P = 0.040), higher postcase clinician frustration ratings ( P < 0.001), higher ratings of patient stress ( P = 0.019), and lower patient ratings of their quality of life ( P = 0.010), of the quality of clinician teamwork ( P = 0.010), being treated with respect ( P = 0.003), and being listened to carefully ( P = 0.012). Trained patient raters evaluated NRE severity significantly higher than did clinician raters ( P < 0.001), while clinicians rated recurrence likelihood significantly higher than patients for both clinician ( P = 0.032) and patient-reported NREs ( P = 0.001). CONCLUSIONS: Both patients and clinicians readily report events during clinical care that they believe deviate from optimal care expectations. These 2 primary stakeholders in safe, high-quality surgical care have different experiences and perspectives regarding NREs. The combination of patient- and clinician-reported NREs seems to be a promising patient-centered method of identifying healthcare system deficiencies and opportunities for improvement.

A pilot study to determine the incidence, type, and severity of non-routine events in neonates undergoing gastrostomy tube placement.

BACKGROUND: Non-routine events (NRE) are defined as any suboptimal occurrences in a process being measured in the opinion of the reporter and comes from the field of human factors engineering. These typically occur well up-stream of an adverse event and NRE measurement has not been applied to the complex context of neonatal surgery. We sought to apply this novel safety event measurement methodology to neonates in the NICU undergoing gastrostomy tube placement. METHODS: A prospective pilot study was conducted between November 2016 and August 2020 in the Level IV NICU and the pediatric operating rooms of an urban academic children's hospital to determine the incidence, severity, impact, and contributory factors of clinician-reported non-routine events (NREs, i.e., deviations from optimal care) and 30-day NSQIP occurrences in neonates receiving a G-tube. RESULTS: Clinicians reported at least one NRE in 32 of 36 (89%) G-tube cases, averaging 3.0 (Standard deviation: 2.5) NRE reports per case. NSQIP-P review identified 7 cases (19%) with NSQIP-P occurrences and each of these cases had multiple reported NREs. One case in which NREs were not reported was without NSQIP-P occurrences. The odds ratio of having a NSQIP-P occurrence with the presence of an NRE was 0.695 (95% CI 0.06-17.04). CONCLUSION: Despite being considered a "simple" operation, >80% of neonatal G-tube placement operations had at least one reported NRE by an operative team member. In this pilot study, NRE occurrence was not significantly associated with the subsequent reporting of an NSQIP-P occurrence. Understanding contributory factors of NREs that occur in neonatal surgery may promote surgical safety efforts and should be evaluated in larger and more diverse populations. LEVEL OF EVIDENCE: IV.

Defining the Epidemiology of Safety Risks in Neonatal Intensive Care Unit Patients Requiring Surgery.

OBJECTIVE: The aim of the study was to determine the incidence, type, severity, preventability, and contributing factors of nonroutine events (NREs)-events perceived by care providers or skilled observers as a deviations from optimal care based on the clinical situation-in the perioperative (i.e., preoperative, operative, and postoperative) care of surgical neonates in the neonatal intensive care unit and operating room. METHODS: A prospective observational study of noncardiac surgical neonates, who received preoperative and postoperative neonatal intensive care unit care, was conducted at an urban academic children's hospital between November 1, 2016, and March 31, 2018. One hundred twenty-nine surgical cases in 109 neonates were observed. The incidence and description of NREs were collected via structured researcher-administered survey tool of involved clinicians. Primary measurements included clinicians' ratings of NRE severity and contributory factors and trained research assistants' ratings of preventability. RESULTS: One or more NREs were reported in 101 (78%) of 129 observed cases for 247 total NREs. Clinicians reported 2 (2) (median, interquartile range) NREs per NRE case with a maximum severity of 3 (1) (possible range = 1-5). Trained research assistants rated 47% of NREs as preventable and 11% as severe and preventable. The relative risks for National Surgical Quality Improvement Program - pediatric major morbidity and 30-day mortality were 1.17 (95% confidence interval = 0.92-1.48) and 1.04 (95% confidence interval = 1.00-1.08) in NRE cases versus non-NRE cases. CONCLUSIONS: The incidence of NREs in neonatal perioperative care at an academic children's hospital was high and of variable severity with a myriad of contributory factors.

Pediatric Anesthesia Specialty Societies and Multi-Institutional Collaborations.

Pediatric anesthesiology is a subspecialty of anesthesiology that deals with the high-risk pediatric population. The specialty has made significant advancement in large collaborative efforts to study and increase patient safety, including the creation of international societies, a dedicated journal, special committees and interest groups, and multi-institution databases for research and quality improvement. Readily available resources were created to help with the education of future pediatric anesthesiologists as well as continuing medical education. Conclusions: Specialty societies and collaborations in pediatric anesthesia are crucial for continuous improvement in the care of children. They promote research, education, quality improvement, and advocacy at the local, national, and international level.

Hot Topics in Safety for Pediatric Anesthesia.

Anesthesiology is one of the leading medical specialties in patient safety. Pediatric anesthesiology is inherently higher risk than adult anesthesia due to differences in the physiology in children. In this review, we aimed to describe the highest yield safety topics for pediatric anesthesia and efforts to ameliorate risk. Conclusions: Pediatric anesthesiology has made great strides in patient perioperative safety with initiatives including the creation of a specialty society, quality and safety committees, large multi-institutional research efforts, and quality improvement initiatives. Common pediatric peri-operative events are now monitored with multi-institution and organization collaborative efforts, such as Wake Up Safe.

Outcomes from wake up safe, the pediatric anesthesia quality improvement initiative.

BACKGROUND: Wake Up Safe, a Patient Safety Organization founded by the Society for Pediatric Anesthesia, collects data on serious adverse events along with demographic data from all pediatric patients receiving anesthesia care at participating institutions. This report reviews all events occurring between 2010 and 2015 and focuses on common adverse events that are anesthesia-related. AIMS: Determine which adverse events were most common from 2010 to 2015 among participating Wake Up Safe institutions. Determine how many anesthesia-related events were deemed to be preventable. METHODS: This is a descriptive report. The Wake Up Safe registry data were queried on September 29, 2017. Institutions were included if they had complete demographic data and at least 5 adverse events per year reported. At that time, 19 out of 29 institutions had complete demographic data for events from 2010 to 2015. This study describes demographic data and adverse events from these nineteen institutions. Descriptive data were extracted, and event rate was calculated for each adverse event category. In events that were assessed as primarily related to anesthesia, further detailed analysis was performed. RESULTS: Of all reported adverse events (2544 events), the most common were cardiac arrests (646, 31.6%), respiratory complications (598, 29.2%), and medication events (345, 16.9%). Of all anesthesia-related events (612 events), medication events were the most common (239, 31.9%), followed by respiratory complications (181, 24.1%), and cardiac arrests (139, 18.5%). Overall, 85% of anesthesia-related serious adverse events were deemed somewhat or almost certainly preventable. CONCLUSIONS: The majority of anesthesia-related serious adverse events reported to the Wake Up Safe database are preventable. Medication events are the most common anesthesia-related adverse events. Innovations aimed at decreasing medication events may be the most impactful.

Residual Weakness and Recurarization After Sugammadex Administration in Pediatric Patients: A Case Series.

While shown to be safe for administration in pediatric patients, sugammadex has recently been associated with residual weakness or recurarization. We describe 4 additional cases of pediatric patients with residual or recurrent weakness following rocuronium reversal with sugammadex. Two infant patients developed postoperative ventilatory distress, which was possibly related to recurarization after sugammadex reversal. A third patient received sugammadex with apparent waning of clinical effect and subsequently required neostigmine reversal. A fourth patient was observed to have residual weakness, which led to prolonged intubation despite appropriate train-of-four results after reversal with sugammadex.

Incidence and Classification of Nonroutine Events during Anesthesia Care.

BACKGROUND: A nonroutine event is any aspect of clinical care perceived by clinicians or trained observers as a deviation from optimal care based on the context of the clinical situation. The authors sought to delineate the incidence and nature of intraoperative nonroutine events during anesthesia care. METHODS: The authors prospectively collected audio, video, and relevant clinical information on 556 cases at three academic hospitals from 1998 to 2004. In addition to direct observation, anesthesia providers were surveyed for nonroutine event occurrence and details at the end of each study case. For the 511 cases with reviewable video, 400 cases had no reported nonroutine events and 111 cases had at least one nonroutine event reported. Each nonroutine event was analyzed by trained anesthesiologists. Rater reliability assessment, comparisons (nonroutine event vs. no event) of patient and case variables were performed. RESULTS: Of 511 cases, 111 (21.7%) contained 173 nonroutine events; 35.1% of event-containing cases had more than one nonroutine event. Of the 173 events, 69.4% were rated as having patient impact and 12.7% involved patient injury. Longer case duration (25th vs. 75th percentile; odds ratio, 1.83; 95% CI, 1.15 to 2.93; P = 0.032) and presence of a comorbid diagnosis (odds ratio, 2.14; 95% CI, 1.35 to 3.40; P = 0.001) were associated with nonroutine events. Common contributory factors were related to the patient (63.6% [110 of 173]) and anesthesia provider (59.0% [102 of 173]) categories. The most common patient impact events involved the cardiovascular system (37.4% [64 of 171]), airway (33.3% [57 of 171]), and human factors, drugs, or equipment (31.0% [53 of 171]). CONCLUSIONS: This study describes characteristics of intraoperative nonroutine events in a cohort of cases at three academic hospitals. Nonroutine event-containing cases were commonly associated with patient impact and injury. Thus, nonroutine event monitoring in conjunction with traditional error reporting may enhance our understanding of potential intraoperative failure modes to guide prospective safety interventions.

Handovers in Perioperative Care.

Handovers around the time of surgery are common, yet complex and error prone. Interventions aimed at improving handovers have shown increased provider satisfaction and teamwork, improved efficiency, and improved communication and have been shown to reduce errors and improve clinical outcomes in some studies. Common recommendations in the literature include a standardized institutional process that allows flexibility among different units and settings, the completion of urgent tasks before information transfer, the presence of all members of the team for the duration of the handover, a structured conversation that uses a cognitive aid, and education in team skills and communication.

Prevalence of Potentially Distracting Noncare Activities and Their Effects on Vigilance, Workload, and Nonroutine Events during Anesthesia Care.

BACKGROUND: When workload is low, anesthesia providers may perform non-patient care activities of a clinical, educational, or personal nature. Data are limited on the incidence or impact of distractions on actual care. We examined the prevalence of self-initiated nonclinical distractions and their effects on anesthesia workload, vigilance, and the occurrence of nonroutine events. METHODS: In 319 qualifying cases in an academic medical center using a Web-based electronic medical chart, a trained observer recorded video and performed behavioral task analysis. Participant workload and response to a vigilance (alarm) light were randomly measured. Postoperatively, participants were interviewed to elicit possible nonroutine events. Two anesthesiologists reviewed each event to evaluate their association with distractions. RESULTS: At least one self-initiated distraction was observed in 171 cases (54%), largely during maintenance. Distractions accounted for 2% of case time and lasted 2.3 s (median). The most common distraction was personal internet use. Distractions were more common in longer cases but were not affected by case type or American Society of Anesthesiologists physical status. Workload ratings were significantly lower during distraction-containing case periods and vigilance latencies were significantly longer in cases without any distractions. Three distractions were temporally associated with, but did not cause, events. CONCLUSIONS: Both nurse anesthetists and residents performed potentially distracting tasks of a personal and/or educational nature in a majority of cases. Self-initiated distractions were rarely associated with events. This study suggests that anesthesia professionals using sound judgment can self-manage nonclinical activities. Future efforts should focus on eliminating more cognitively absorbing and less escapable distractions, as well as training in distraction management.

Evaluation of the skin to epidural and subarachnoid space distance in young children using magnetic resonance imaging.

BACKGROUND AND OBJECTIVES: Epidural catheters placed for perioperative analgesia in young children confer clinical benefits but are technically challenging to insert. Approximations of the skin to epidural space depth in this population are limited to direct needle measurement and ultrasonography. Magnetic resonance imaging (MRI) is the most comprehensive imaging modality of the spine. This study aims to produce a more clinically useful formula from MRI data to estimate pediatric epidural depth. METHODS: Seventy children with normal lumbar spine MR images were enrolled. After determination of epidural depth, linear regression was used to estimate a weight-based formula. Analysis of variance and bootstrap methods were used to evaluate this formula against 4 commonly cited formulae. The quality of predictions was evaluated using the mean absolute prediction error. RESULTS: The estimated weight-based formula as derived by MRI data is given by: skin to epidural depth (mm) = 9.00 + 0.62 * weight in kilograms. The mean absolute prediction error was 2.56 mm (95% confidence interval [95% CI], 2.12-3.04) for the new formula. Additional derived formulae are skin to dorsal dura depth (mm) = 13.52 + 0.71 * weight in kilograms (mean absolute prediction error, 2.48 mm; 95% CI, 2.00-3.03) and skin to ventral dural depth (mm) = 23.08 + 0.86 * weight in kilograms (mean absolute prediction error, 2.50 mm; 95% CI, 2.04-3.06). CONCLUSIONS: We provide the first predictive formulae, based on MRI data, for pediatric epidural depth estimation.

A multispecialty pediatric neurovascular conference: a model for interdisciplinary management of complex disease.

INTRODUCTION: In 2013, our institution established a multidisciplinary pediatric neurovascular conference for coordination of care. Here, we review our initial experience. METHODS: Clinical and demographic data were obtained from medical records for patients presented to the pediatric neurovascular conference from April 2013 to July 2014. Patient descriptive characteristics were described by mean and standard deviation for continuous measures and by number and percent for categorical measures. Patients were secondarily stratified by lesion/disease type, and descriptive statistics were used to measure demographic and clinical variables. RESULTS: The pediatric neurovascular conference met 26 times in the study period. Overall, 75 children were presented to the conference over a 15-month period. The mean age was 9.8 (standard deviation, 6.3) years. There were 42 (56%) male patients. These 75 children were presented a total of 112 times. There were 28 (37%) patients with history of stroke. Complex vascular lesions were the most frequently discussed entity; of 62 children (83%) with a diagnosed vascular lesion, brain arteriovenous malformation (29%), cavernous malformation (15%), and moyamoya (11%) were most common. Most discussions were for review of imaging (35%), treatment plan formulation (27%), the need for additional imaging (25%), or diagnosis (13%). Standardized care protocols for arteriovenous malformation and moyamoya were developed. CONCLUSION: A multidisciplinary conference among a diverse group of providers guides complex care decisions, helps standardize care protocols, promotes provider collaboration, and supports continuity of care in pediatric neurovascular disease.

Identification and characterization of a compound that protects cardiac tissue from human Ether-à-go-go-related gene (hERG)-related drug-induced arrhythmias.

The human Ether-à-go-go-related gene (hERG)-encoded K(+) current, I(Kr) is essential for cardiac repolarization but is also a source of cardiotoxicity because unintended hERG inhibition by diverse pharmaceuticals can cause arrhythmias and sudden cardiac death. We hypothesized that a small molecule that diminishes I(Kr) block by a known hERG antagonist would constitute a first step toward preventing hERG-related arrhythmias and facilitating drug discovery. Using a high-throughput assay, we screened a library of compounds for agents that increase the IC(70) of dofetilide, a well characterized hERG blocker. One compound, VU0405601, with the desired activity was further characterized. In isolated, Langendorff-perfused rabbit hearts, optical mapping revealed that dofetilide-induced arrhythmias were reduced after pretreatment with VU0405601. Patch clamp analysis in stable hERG-HEK cells showed effects on current amplitude, inactivation, and deactivation. VU0405601 increased the IC(50) of dofetilide from 38.7 to 76.3 nM. VU0405601 mitigates the effects of hERG blockers from the extracellular aspect primarily by reducing inactivation, whereas most clinically relevant hERG inhibitors act at an inner pore site. Structure-activity relationships surrounding VU0405601 identified a 3-pyridiyl and a naphthyridine ring system as key structural components important for preventing hERG inhibition by multiple inhibitors. These findings indicate that small molecules can be designed to reduce the sensitivity of hERG to inhibitors.

Using the healthcare matrix with interns and medical students as a tool to effect change.

The Healthcare Matrix is a tool developed at Vanderbilt University Medical Center which assesses the care of patients using the Accreditation Council for Graduate Medical Education (ACGME) competencies and the Institute of Medicine (IOM) Aims for Improvement. House staff have been using this tool since 2004 as a means of learning the competencies in the daily care of patients. As the residents fill in the cells of the Matrix, the opportunities for improvement become evident. Anesthesia interns were introduced to the Matrix at bimonthly meetings to analyze a real case of complex and/or flawed patient management. Each resident completed his/her own Matrix and then the group selected one Matrix as their improvement project. This article will present one Matrix case, how quality improvement (QI) tools and methods were utilized and what resulting improvements were made. The analyzed case revealed numerous flaws with nonstandardized handoffs, incorrect and insufficient documentation, and unclear roles/responsibilities. An ideal process flowchart was developed highlighting improved handoffs and the need for a new admitting policy to the intensive care unit (ICU). The Healthcare Matrix is an effective tool for teaching the ACGME competencies in patient care. The resequencing of the competencies in the Matrix makes it easy to identify where improvements are needed. When taught the tools and methods of quality improvement, even interns can make a significant contribution to the improvement of patient care.