Objectives: Tracheal intubation (TI) is a critical skill for PICU attending physicians to maintain. We hypothesize that attendings perform fewer TIs and have lower success rate in PICU programs with a Pediatric Critical Care Medicine (PCCM) fellowship. Design: Retrospective study using the National Emergency Airway Registry for Children (NEAR4KIDS) from July 2016 to June 2020. Exposures were presence of PCCM fellowship and attending TI skill maintenance program (SMP). The primary outcome was attending's first attempt success and the secondary outcome was adverse airway outcome in the first attempt. Setting: Thirty-three PICUs in North America. Patients: Children receiving TI. Interventions: None. Measurements and Main Results: Overall, 23 of 33 PICUs had a PCCM fellowship with three of 23 having an attending TI SMP. Attendings performed TI in 24.1% (2,728/11,323): 13.9% (13.8 TI/yr per PICU) in PICUs with a fellowship vs. 66.0% (36.6 TI/yr per PICU) without a fellowship (p < 0.001). Attending first attempt success in PICUs with vs. without fellowships was 70.5% vs. 81.3% (difference, 10.8% [95% CI, 7.6-14.0%]; p < 0.0001). After controlling for confounders, attendings in a PICU with a fellowship had lower odds for first attempt success (adjusted odds ratio [aOR], 0.65 [95% CI, 0.47-0.90]). We failed to find an association between attending first attempt success and PICU program type, with vs. without a TI SMP (74.0% vs. 69.5%; p = 0.146). The adverse airway outcome rate of the TI with attending's first attempt was lower in PICU programs with vs. without a TI SMP (32.8% vs. 40.3%; p = 0.020). However, after adjusting for confounders, we failed to exclude the possibility of near halving of odds of adverse outcome (aOR, 0.75 [95% CI, 0.55-1.01]; p = 0.058). Conclusions: Attendings in PICU programs with a fellowship have fewer opportunities to perform TI and lower first attempt success rates. Opportunities exist for attending TI skill maintenance, especially in PICUs with a PCCM fellowship.

OBJECTIVES:Sedation and analgesia for infants and children requiring mechanical ventilation in the PICU is uniquely challenging due to the wide spectrum of ages, developmental stages, and pathophysiological processes encountered. Studies evaluating the safety and efficacy of sedative and analgesic management in pediatric patients have used heterogeneous methodologies. The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research (SCEPTER) IV hosted a series of multidisciplinary meetings to establish consensus statements for future clinical study design and implementation as a guide for investigators studying PICU sedation and analgesia.DESIGN:Twenty-five key elements framed as consensus statements were developed in five domains: study design, enrollment, protocol, outcomes and measurement instruments, and future directions.SETTING:A virtual meeting was held on March 2-3, 2022, followed by an in-person meeting in Washington, DC, on June 15-16, 2022. Subsequent iterative online meetings were held to achieve consensus.SUBJECTS:Fifty-one multidisciplinary, international participants from academia, industry, the U.S. Food and Drug Administration, and family members of PICU patients attended the virtual and in-person meetings. Participants were invited based on their background and experience.INTERVENTIONS:None.MEASUREMENTS AND MAIN RESULTS:Common themes throughout the SCEPTER IV consensus statements included using coordinated multidisciplinary and interprofessional teams to ensure culturally appropriate study design and diverse patient enrollment, obtaining input from PICU survivors and their families, engaging community members, and using developmentally appropriate and validated instruments for assessments of sedation, pain, iatrogenic withdrawal, and ICU delirium.CONCLUSIONS:These SCEPTER IV consensus statements are comprehensive and may assist investigators in the design, enrollment, implementation, and dissemination of studies involving sedation and analgesia of PICU patients requiring mechanical ventilation. Implementation may strengthen the rigor and reproducibility of research studies on PICU sedation and analgesia and facilitate the synthesis of evidence across studies to improve the safety and quality of care for PICU patients.

Respiratory complaints, and concern for the presence and/or development of hypoxemia, compose one of the most common reasons for pediatric patients to present for health care provider evaluation, and disposition decisions for these providers are strongly influenced by SpO2 measured by pulse oximetry.1,2 Whereas in the acute care setting SpO2 monitoring with medical-grade devices is standard practice, pulse oximetry monitoring in the home setting is increasingly common either for children with chronic cardiorespiratory disease or by individuals who are simply curious about their oxygen status. There is wide variability in provider decisions to prescribe home pulse oximetry.3 However, feasibility and efficacy of this practice have been described in several adult and pediatric conditions including obstructive sleep apnea,4 acute COVID-19,5 bronchopulmonary dysplasia,6 and congenital cardiac disease.7,8 Whereas monitoring in these scenarios is typically performed using medical-grade devices, patients and/or their parents are increasingly able to obtain non–medical-grade (home grade) devices designed for out-of-hospital use, which can be inexpensively purchased in person or online. Whereas medical-grade pulse oximeters are approved by regulatory bodies such as the United States FDA and must be accurate within 3% of a measured oxyhemoglobin saturation, these home-grade pulse oximeters are not subject to the same approval rigor.9 Because of the ease with which caregivers or patients can purchase these devices, it behooves the medical community to understand their accuracy and limitations.9,10 Whereas some studies11 have been performed to assess the accuracy of home-grade devices in adults, pediatric data are scarce and limited by either small sample sizes or lack of enrolled subjects with overt hypoxemia.12,13 … Correspondence: John W Berkenbosch MD, Pediatrics/Pediatric Critical Care University of Louisville, Norton Children's Hospital 571 S. Floyd, Suite 332, Louisville, KY 40202. E-mail: john.berkenbosch{at}louisville.edu

Enteral ibuprofen was first approved as a prescription drug in 1974 for the US market. An intravenous (IV) ibuprofen formulation is approved for use in children older than 6 months of age, but there are limited studies specifically evaluating the pharmacokinetics and safety in children 1–6 months of age. The primary purpose of this study was to evaluate the pharmacokinetics of IV ibuprofen in infants younger than 6 months of age. The secondary objective was to evaluate the safety of single and repeated doses of IV ibuprofen in infants younger than 6 months of age. This was an industry-sponsored multi-center study. Institutional Review Board approval and informed parental consent were obtained prior to enrollment. Hospitalized neonates and infants younger than 6 months of age with fever or expected postoperative pain were eligible. Enrolled patients received 10 mg/kg of IV ibuprofen every 6 h, with up to four doses per day. Patients were randomized to two sparse sampling technique pharmacokinetic sample time groups. Group 1 samples were drawn at 0, 30 min, and 2 h, while group 2 samples were drawn at 0 min, 1, and 4 h after administration. A total of 24 children were enrolled in the study, with 15 male patients and 9 female patients. The median age of the cohort was 4.4 months (range 1.1–5.9 months), and the median weight was 5.9 kg (range 2.3–8.8 kg). The arithmetic mean and standard error for peak plasma ibuprofen concentration was 56.28 ± 2.77 µg/mL. Plasma levels declined rapidly with a mean elimination half-life of 1.30 h. Time to peak ibuprofen effect and concentration were similar when compared with older pediatric patients. Clearance and volume of distribution were also similar to those reported in older pediatric patients. No drug-related adverse events were reported. The pharmacokinetic and short-term safety profiles of IV ibuprofen in pediatric patients 1–6 months of age are comparable to those in children older than 6 months of age. Clinicaltrials.gov Trial Registration number and date: NCT02583399—Registered July 2017.

Introduction: Endotracheal intubation can be associated with adverse events, including severe desaturation. Non-invasive ventilation (NIV) is often used to reduce the need for intubation; however, some patients will fail NIV and require intubation. Few data surrounding the association between NIV settings and risk of desaturation during intubation exists. We sought to identify the at-risk population and modifiable risk factors associated with severe desaturation during intubation among patients receiving NIV. Methods: We reviewed all intubations at our institution from 10/2018—07/2020. Severe desaturation was defined as SpO2 < 70% or >15% decrease in patients with congenital heart disease. Collected data included FiO2 2-hours prior to and at time of intubation (high FiO2 was ≥0.6), NIV settings and duration, indication for intubation, pH, heart rate, and respiratory rate at intubation, intubator, and number of intubation attempts. High NIV support was defined as any level of BiPAP or CPAP, increased home vent settings, and high flow nasal cannula >2L/kg/min (< 12mo), ≥15LPM (1-2yo), ≥20LPM (3-11yo), or ≥30LPM (12-18yo). Univariate and multivariate analyses were used to determine risks associated with severe desaturation in these patients. Results: After exclusions, 245 intubations were included with 122 on high support and 123 on low support. Those requiring high support were younger and weighed less. They were also more likely to require high FiO2 and have a longer duration on NIV prior to intubation. Of 30 documented severe desaturation events, more patients had high NIV support, higher FiO2, and longer NIV duration prior to intubation and had an increased number of intubation attempts. Those on high support were more likely to be intubated by an attending. Those on high NIV did not have any significant variables associated with risk of desaturation. Those on low NIV had FiO2, duration of NIV, CO2 prior to intubation, and multiple intubation attempts associated with risk of desaturation. Conclusions: The use of NIV may potentially contribute to risk of severe desaturation if the settings are high or the duration is prolonged. Further investigation, with a standardized definition of high support, is needed to demonstrate more modifiable risk factors associated with severe desaturation in these patients.

BACKGROUND: Endotracheal intubation is a common procedure associated with adverse events, including severe desaturation. Many patients receive noninvasive respiratory support to reduce the need for intubation. There are minimal data about the association between noninvasive respiratory support and the risk of a severe desaturation event during intubation. We aim to differentiate patients based on the level of noninvasive respiratory support, analyze the severe desaturation event by groups, and identify modifiable risk factors. METHODS: Oral intubations, excluding tube exchanges or re-intubation after unplanned extubation, from October 2018 through July 2020, at the study site were reviewed. A severe desaturation event was defined as SpO2 < 70% or a >15% decrease from baseline in cyanotic heart disease. We analyzed outcomes by 4 groups: room air/nasal cannula (≤0.5 L/kg/min), high-flow nasal cannula (HFNC) (0.5–2 L/kg/min), high HFNC (≥2 L/kg/min), and noninvasive ventilation (NIV). RESULTS: Of 243 subjects who were intubated, 31% were receiving room air/nasal cannula, 25% were receiving HFNC, 18% were receiving high HFNC, and 26% were receiving NIV. Twelve percent of all the subjects had a severe desaturation event. In a univariate analysis, the incidence of a severe desaturation event was similar among all levels of respiratory support (P = .14). A severe desaturation event was more likely in those subjects who were receiving FIO2 ≥ 0.6 at the time of the decision to intubate (19.6%) versus FIO2 < 0.6 (8.1%) (P = .02). The duration of noninvasive respiratory support was longer (5 vs 1 h; P = .02) among those with a severe desaturation event. In a regression analysis, when adjusting for ≥2 intubation attempts pre-intubation, NIV use was independently associated with increased odds of severe desaturation events (odds ratio 3.14, CI 1.08–10.5). CONCLUSIONS: Results of our study suggest that FIO2 > 0.60, the duration of noninvasive respiratory support, and exposure to NIV before an intubation are risk factors of severe desaturation events during intubation.

Ketamine has traditionally been avoided for tracheal intubations (TIs) in patients with acute neurological conditions. We evaluate its current usage pattern in these patients and any associated adverse events. We conducted a retrospective observational cohort study of critically ill children undergoing TI for neurological indications in 53 international pediatric intensive care units and emergency departments. We screened all intubations from 2014 to 2020 entered into the multicenter National Emergency Airway Registry for Children (NEAR4KIDS) registry database. Patients were included if they were under the age of 18 years and underwent TI for a primary neurological indication. Usage patterns and reported periprocedural composite adverse outcomes (hypoxemia < 80

OBJECTIVES: To describe tracheal intubation (TI) practice by Advanced Practice Registered Nurses (APRNs) in North American PICUs, including rates of TI-associated events (TIAEs) from 2015 to 2019. DESIGN/SETTING: Retrospective study using the National Emergency Airway Registry for Children with all TIs performed in PICU and pediatric cardiac ICU between January 2015 and December 2019. The primary outcome was first attempt TI success rate. Secondary outcomes were TIAEs, severe TIAEs, and hypoxemia. SUBJECTS: Critically ill children requiring TI in a PICU or pediatric cardiac ICU. INTERVENTIONS: None MEASUREMENTS AND MAIN RESULTS: Among 11,012 TIs, APRNs performed 1,626 (14.7%). Overall, TI by APRNs, compared with other clinicians, occurred less frequently in patients with known difficult airway (11.1% vs. 14.3%; p < 0.001), but more frequently in infants younger than 1 year old (55.9% vs. 44.4%; p < 0.0001), and in patients with cardiac disease (26.3% vs. 15.9%; p < 0.0001).There was lower odds of success in first attempt TI for APRNs vs. other clinicians (adjusted odds ratio, 0.70; 95% CI, 0.62–0.79). We failed to identify a difference in rates of TIAE, severe TIAE, and oxygen desaturation events for TIs by APRNs compared with other clinicians. The TI first attempt success rate improved with APRN experience (< 1 yr: 54.2%, 1–5 yr: 59.4%, 6–10 yr: 67.6%, > 10 yr: 63.1%; p = 0.021). CONCLUSIONS: TI performed by APRNs was associated with lower odds of first attempt success when compared with other ICU clinicians although there was no appreciable difference in procedural adverse events. There appears to be a positive relationship between experience and success rates. These data suggest there is an ongoing need for opportunities to build on TI competency with APRNs.

RATIONALE:A guideline that both evaluates current practice and provides recommendations to address sedation, pain, and delirium management with regard for neuromuscular blockade and withdrawal is not currently available.OBJECTIVE:To develop comprehensive clinical practice guidelines for critically ill infants and children, with specific attention to seven domains of care including pain, sedation/agitation, iatrogenic withdrawal, neuromuscular blockade, delirium, PICU environment, and early mobility.DESIGN:The Society of Critical Care Medicine Pediatric Pain, Agitation, Neuromuscular Blockade, and Delirium in critically ill pediatric patients with consideration of the PICU Environment and Early Mobility Guideline Taskforce was comprised of 29 national experts who collaborated from 2009 to 2021 via teleconference and/or e-mail at least monthly for planning, literature review, and guideline development, revision, and approval. The full taskforce gathered annually in-person during the Society of Critical Care Medicine Congress for progress reports and further strategizing with the final face-to-face meeting occurring in February 2020. Throughout this process, the Society of Critical Care Medicine standard operating procedures Manual for Guidelines development was adhered to.METHODS:Taskforce content experts separated into subgroups addressing pain/analgesia, sedation, tolerance/iatrogenic withdrawal, neuromuscular blockade, delirium, PICU environment (family presence and sleep hygiene), and early mobility. Subgroups created descriptive and actionable Population, Intervention, Comparison, and Outcome questions. An experienced medical information specialist developed search strategies to identify relevant literature between January 1990 and January 2020. Subgroups reviewed literature, determined quality of evidence, and formulated recommendations classified as "strong" with "we recommend" or "conditional" with "we suggest." Good practice statements were used when indirect evidence supported benefit with no or minimal risk. Evidence gaps were noted. Initial recommendations were reviewed by each subgroup and revised as deemed necessary prior to being disseminated for voting by the full taskforce. Individuals who had an overt or potential conflict of interest abstained from relevant votes. Expert opinion alone was not used in substitution for a lack of evidence.RESULTS:The Pediatric Pain, Agitation, Neuromuscular Blockade, and Delirium in critically ill pediatric patients with consideration of the PICU Environment and Early Mobility taskforce issued 44 recommendations (14 strong and 30 conditional) and five good practice statements.CONCLUSIONS:The current guidelines represent a comprehensive list of practical clinical recommendations for the assessment, prevention, and management of key aspects for the comprehensive critical care of infants and children. Main areas of focus included 1) need for the routine monitoring of pain, agitation, withdrawal, and delirium using validated tools, 2) enhanced use of protocolized sedation and analgesia, and 3) recognition of the importance of nonpharmacologic interventions for enhancing patient comfort and comprehensive care provision.

Damme, Danielle Van1; McRae, Emily2; Irving, Sharon3; Kelly, Serena4; Nishisaki, Akira5; Berkenbosch, John6 Author Information

Use of viscoelastic tests (VETs), including thromboelastography (TEG) and rotational thromboelastometry (ROTEM), is increasing in the management of anticoagulation in extracorporeal membrane oxygenation (ECMO) patients. A retrospective review of data on 265 pediatric (<20 years old) ECMO patients who underwent VET and were submitted to the Pediatric ECMO Outcomes Registry (PEDECOR) was conducted to describe common coagulopathies in patients who underwent VET; associations between the VET parameters and traditional tests of coagulation; and comparisons in blood product usage in patients who underwent VET with those who did not. We calculated patient-level summary statistics and assessed differences between the groups using chi(2) tests (categorical variables) and Kruskal-Wallis and Wilcoxon rank-sum tests (continuous variables). Viscoelastic test was utilized in 77% of patients in the analysis. Platelet dysfunction was the most common abnormality identified by TEG (30.8%) and ROTEM (9.7%). Bleeding patients who had VET performed received more cryoprecipitate transfusions than those who did not have VET (VET median = 9.7 ml/kg; interquartile range (IQR) = 4.3-22.0 ml/kg vs. no VET median = 5.1 ml/kg; IQR = 0-10.4 ml/kg; p = 0.0013). Given the growing use of VET in pediatric ECMO patients, further studies evaluating VET in managing complications as well as aiding in titration of anticoagulation therapy are needed.

目的:气管插管(tracheal intubation，TI)不良事件风险较高。目前文献对PICU内气管插管安全性的"新受训者效应"尚无清楚报告。本文评估PICU主治医生学术周期时机对TI相关事件(TI associated events，TIAEs)的影响。本文假设(1)具有儿科重症监护医学(pediatric critical care medicine，PCCM)主治医生培训计划的PICUs在学年的第1季度(7-9月)与本学年其余时间相比有更多的TIAEs；(2)PCCM主治医师首次插管成功情况及TIAE发生率通过3年的临床培训得到改善。设计:回顾性队列研究。场所:37家加入国家儿童紧急气道登记数据库(NEAR4KIDS)的北美PICUs。对象:2013年7月至2017年6月在PICU接受TI的所有患儿。干预:无。测量方法和主要结果:将四种不同类型PICUs(有主治和住院医师的PICUs，仅有主治医师的PICUs，仅有住院医师的PICUs，以及没有受训人员的PICUs)第1季度(7-9月)发生的所有TIAEs情况与其余时间进行比较。对于第2个假设，PCCM主治医师完成的TIs按培训水平和3年主治医师培训期的不同季度进行分类(如第1年PCCM主治医师培训期的7-9月＝1st季度，第1年的10-12月＝2st季度，第3年的4月-6月＝12st季度)。结论:在不同类型的PICUs中未观察到新受训人员对TI安全性预后的影响。PCCM主治医师首次插管成功率显著提高，TIAE率显著下降，提示其在整个PCCM主治医师培训期间习得了大量技能。

Komeswaran, Kavipriya; Hamelink, Alexis; Scott, Taryn; Infanti, Lisa; Berkenbosch, John Author Information

OBJECTIVES:Tracheal intubation carries a high risk of adverse events. The current literature is unclear regarding the "New Trainee Effect" on tracheal intubation safety in the PICU. We evaluated the effect of the timing of the PICU fellow academic cycle on tracheal intubation associated events. We hypothesize 1) PICUs with pediatric critical care medicine fellowship programs have more adverse tracheal intubation associated events during the first quarter (July-September) of the academic year compared with the rest of the year and 2) tracheal intubation associated event rates and first attempt success performed by pediatric critical care medicine fellows improve through the 3-year clinical fellowship. DESIGN:Retrospective cohort study. SETTING:Thirty-seven North American PICUs participating in National Emergency Airway Registry for Children. PATIENTS:All patients who underwent tracheal intubations in the PICU from July 2013 to June 2017. INTERVENTIONS:None. MEASUREMENTS AND MAIN RESULTS:The occurrence of any tracheal intubation associated events during the first quarter of the academic year (July-September) was compared with the rest in four different types of PICUs: PICUs with fellows and residents, PICUs with fellows only, PICUs with residents only, and PICUs without trainees. For the second hypothesis, tracheal intubations by critical care medicine fellows were categorized by training level and quarter for 3 years of fellowship (i.e., July-September of 1st yr pediatric critical care medicine fellowship = first quarter, October-December of 1st yr pediatric critical care medicine fellowship = second quarter, and April-June during 3rd year = 12th quarter). A total of 9,774 tracheal intubations were reported. Seven-thousand forty-seven tracheal intubations (72%) were from PICUs with fellows and residents, 525 (5%) with fellows only, 1,201 (12%) with residents only, and 1,001 (10%) with no trainees. There was no difference in the occurrence of tracheal intubation associated events in the first quarter versus the rest of the year (all PICUs: July-September 14.9% vs October-June 15.2%; p = 0.76). There was no difference between these two periods in each type of PICUs (all p ≥ 0.19). For tracheal intubations by critical care medicine fellows (n = 3,836), tracheal intubation associated events significantly decreased over the fellowship: second quarter odds ratio 0.64 (95% CI, 0.45-0.91), third quarter odds ratio 0.58 (95% CI, 0.42-0.82), and 12th quarter odds ratio 0.40 (95% CI, 0.24-0.67) using the first quarter as reference after adjusting for patient and device characteristics. First attempt success significantly improved during fellowship: second quarter odds ratio 1.39 (95% CI, 1.04-1.85), third quarter odds ratio 1.59 (95% CI, 1.20-2.09), and 12th quarter odds ratio 2.11 (95% CI, 1.42-3.14). CONCLUSIONS:The New Trainee Effect in tracheal intubation safety outcomes was not observed in various types of PICUs. There was a significant improvement in pediatric critical care medicine fellows' first attempt success and a significant decline in tracheal intubation associated event rates, indicating substantial skills acquisition throughout pediatric critical care medicine fellowship.

Department of Pediatrics, Division of Pediatric Critical Care, University of Louisville; and “Just For Kids” Critical Care Center, Norton Children’s Hospital, Louisville, KY *See also p. 625. Dr. Berkenbosch received funding from Pfizer Pharmaceuticals, and he disclosed off-label product use of dexmedetomidine.