Abstract Background Critically unwell babies in intensive care units may develop acute renal failure. Options for renal replacement therapy are limited by their small size and available technology. Objectives To determine the clinical efficacy, outcomes and safety profile of the NIDUS® (a novel infant haemodialysis device) for babies under 8 kg, compared with current renal replacement therapy. Design A clinical investigation using a non-blinded cluster stepped wedge design with paediatric intensive care units randomised to sequences. Setting Paediatric intensive care units in six UK hospitals. Participants Children under 8 kg who required renal replacement therapy for fluid overload or biochemical disturbance. Interventions Continuous renal replacement therapy was provided by the usual methods: peritoneal dialysis and continuous haemofiltration (during control periods) and by the NIDUS (during intervention periods), a novel device designed for babies with a smaller circuit and filter and volumetric control of ultrafiltration. Main outcome measures Primary outcome was precision of ultrafiltration compared with prescription; secondary outcomes included biochemical clearances, accuracy of reported ultrafiltration and mortality. Data sources Bedside study data collected by weighing bags of fluid entering and leaving the device were entered into the study database along with case descriptors. Some secondary outcome data was collected via the Paediatric Intensive Care Audit Network. Results Ninety-seven participants were recruited by study closure, 62 to control and 35 to intervention. The primary outcome was obtained from 62 control but only 21 intervention patients, largely because of technical difficulties using NIDUS. The analysis comparing the available primary outcomes showed that ultrafiltration with NIDUS was closer to that prescribed than with control: standard deviations controls 18.75, intervention 2.95 (ml/hour), adjusted ratio 0.13, 95% confidence interval (0.03 to 0.71); p = 0.018. The mean clearances for creatinine, urea and phosphate were lower on peritoneal dialysis than NIDUS, which were in turn lower than continuous veno-venous haemofiltration. The variability in the clearances was in the same order. Of the 62 control patients, 10 died (2/62 on peritoneal dialysis; 7/13 on continuous haemofiltration) before discharge from paediatric intensive care unit (16%), compared with 12 out of 35 (34%) in the NIDUS group: p = 0.04, 95% confidence interval for difference (0 to 36%). Harms No important adverse events occurred and the NIDUS has an acceptable safety profile compared with other renal replacement therapies in this critically ill population with multi-organ failure. Mortality was lowest for Peritoneal Dialysis, highest for continuous haemofiltration, with the NIDUS in-between. Only one serious adverse device event which was reported to the Medicines and Healthcare products Regulatory Agency. Conclusions NIDUS works effectively, delivering appropriate blood clearances and accurate, controllable fluid removal (ultrafiltration), indicating that it has an important place alongside other dialysis modalities for infant renal replacement therapy. Future work Findings from this study indicate some modifications are required to NIDUS to improve usability. Further studies on use of the NIDUS device in other populations of babies for example those with chronic renal failure, and long-term outcomes are required. Trial registration This trial is registered as ISRCTN 13787486. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Efficacy and Mechanism Evaluation Programme (NIHR award ref: 14/23/26) and is published in full in Efficacy and Mechanism Evaluation; Vol. 11, No. 1. See the NIHR Funding and Awards website for further award information. Plain language summary Why do this study? Some children in intensive care are so poorly that their kidneys do not work well, and they need help, called dialysis, to get rid of fluid and chemicals from their blood. For babies, we currently use peritoneal dialysis, where fluid is cycled in and out of the tummy, or adapted machines designed for bigger children (continuous veno-venous haemofiltration). A new machine, the NIDUS® (Allmed, www.allmedgroup.com), was developed specifically for babies weighing under 8 kg with much smaller tubing. NIDUS worked well when studied in Newcastle but needed testing elsewhere. What was the question? How well does NIDUS work compared to other dialysis methods? What are the problems? What did we do? The study was done in six paediatric intensive care units who used their usual dialysis methods (=control) in the first part of the study and then later swapped to using the NIDUS (=intervention). What did we find? We recruited 97 participants, 62 to control (49 peritoneal dialysis, 13 continuous veno-venous haemofiltration) and 35 intervention (NIDUS). We found NIDUS provided much better control of fluid removal. The CVVH machines were more efficient at blood cleaning than NIDUS, which was better than peritoneal dialysis. What does this mean? We learnt a lot about babies needing kidney support in paediatric intensive care units and that all methods have advantages and disadvantages. We showed that NIDUS could be very useful for some participants because it cleans blood effectively and gives accurate, controllable fluid removal. We have gathered important information to help us improve NIDUS to make it easier to use and run. Many parents responded to our questionnaire and most told us they felt it was acceptable to be approached about taking part in research despite the circumstances. This is very important for future research studies. We are very grateful to families for their generosity in becoming involved in this study. Scientific summary Background Critically unwell babies in paediatric intensive care units (PICUs) may develop acute renal failure and require management with renal replacement therapy. Although mortality and morbidity vary and are related to the underlying diagnosis, survival of babies in paediatric intensive care is worse for those with fluid overload. Babies requiring renal replacement treatment present specific therapeutic challenges because of their small size and the current technology available. Difficulties with vascular access and blood flows, fluid balance, loss of circuits, filter clotting and hypotensive episodes at initiation are all described in the literature. The need for new solutions and improved technology is well recognised. Continuous veno-venous haemofiltration (CVVH) machines in use in the UK at the time of this study are not approved for use in babies weighing <8 kg (<20 kg in the USA), but because of lack of alternatives, they are frequently used by clinicians outside of licence and recommendations. Objectives The objectives of the I-KID study were to determine the clinical efficacy, outcomes and safety profile of a novel non-CE marked infant haemodialysis (HD) device for babies under 8 kg: the NIDUS® (Allmed, www.allmedgroup.com) compared to current renal replacement treatment. Methods The study used a cluster-randomised standard stepped wedge (SW) design with 4 periods and 3 sequences, hence 12 treatment cells. The clusters were PICUs. Conventional therapy [peritoneal dialysis (PD) or CVVH] was used in the control cells, with the NIDUS used in the intervention cells. Each site was trained in setting up and using the NIDUS before switching to an intervention period. The design meant that all participating centres had the chance to use both treatments during the course of the study. PICU nurses were competency-assessed before each site could begin using the intervention; 24-hour on-call nurse/clinician telephone support was provided from Newcastle. Using a SW design permitted phased training on the NIDUS and allowed within-centre comparisons to contribute to the treatment estimate. The setting was PICUs in six hospitals in the UK, chosen because of their experience of performing renal replacement treatment in babies, and willingness to collaborate. Informed consent was sought from parents/guardians of children weighing from 800 g to 8 kg who required renal replacement treatment for fluid overload or biochemical disturbance (babies with suspected inborn errors of metabolism, for example leading to hyperammonaemia were excluded). Because of the urgency of requirement to start renal replacement treatment in some cases, where necessary, deferred consent was sought as soon as possible. Interventions During control periods, renal replacement treatment was provided by the usual methods in each PICU: PD and CVVH and, after a period of training and competency assessment, by the NIDUS during intervention periods. In addition, one infant being treated on an extracorporeal membrane oxygenation circuit during the control period had renal replacement treatment added by the integration of a HD filter inserted into that circuit. There was no blinding. Outcome measures Primary outcome The first observation of precision of fluid removal [ultrafiltration (UF)] from an episode lasting at least one hour for CVVH or the NIDUS, or at least 5 hours for PD within 48 hours of the start of renal replacement treatment. Secondary outcomes (related to the primary outcome) average of all precision values observed on the patient biochemical clearance rates for creatinine, urea and phosphate precision of observed versus reported fluid removal (CVVH and NIDUS only). Other secondary outcomes survival haemodynamic status (drop in blood pressure after connection to CVVH or dialysis device, requiring intervention of fluid bolus or administration of inotropes) number of ventilator-free days during renal replacement treatment completion of intended renal replacement treatment course need for additional vascular or dialysis access unplanned change in circuits exposure to blood transfusion bleeding events anticoagulant use. Secondary outcomes from questionnaires parent/guardian experience staff acceptability and usability of device. Data sources Data were collected on UF by timed weighing of fluid delivery and output bags used by the CVVH (Prismaflex® and Aquarius®) and NIDUS. For PD using manual circuits, volumes delivered and removed were measured by the bedside nurse. Timed UF and blood samples were performed to calculate biochemical clearances. Bedside study data were entered into a bespoke study database along with case descriptors. Some secondary outcome data were collected via the Paediatric Intensive Care Audit Network (PICANet), as this was already established in use at study sites. Results The planned sample size was 95 participants. By study closure 97 participants were recruited, 62 to control and 35 to intervention. Descriptive summaries were similar in both control and intervention groups; around half the participants had unplanned admissions to paediatric intensive care and approximately a third were transferred from outside hospitals. Renal replacement treatment was required post surgery in 52% of control and 40% of intervention cases. For those requiring renal replacement treatment post surgery this involved cardiac bypass surgery in 97% of controls and 84% of intervention participants. Systolic blood pressure, median [interquartile range (IQR)] control 68 (59, 78), intervention 68 (60, 86) mmHg and need for mechanical ventilation (>80%) were similar. The median (IQR) age in controls 10.5 (7, 38) days was similar to that in the intervention group 11 (7, 61) days; the range of age of participants was between 1 and 477 days (approximately 15 months). The median (IQR) weights 3.2 (2.9, 3.9) and 3.7 (3.1, 5.6) kg were similar between control and intervention. Availability of primary outcome The primary outcome was available on all 62 control patients but only 21 of the 35 intervention patients. This was due to a range of reasons including difficulties in obtaining the information needed to compute the UF rate (accurate timing and weighing data) and technical difficulties using the NIDUS: full details are in the report. Precision of UF Analysis comparing the 62 control patients with the 21 intervention patients with a primary outcome showed that UF with the NIDUS was closer to that prescribed than with control: standard deviations (SDs) controls 18.75, intervention 2.95 (ml/hour), adjusted ratio 0.13, 95% confidence interval (0.03 to 0.71); p = 0.018. For the NIDUS and CVVH devices, an important measure was to compare the difference between the actual fluid removal measured and that reported by the device. This had a mean closer to zero for the NIDUS than CVVH (means −0.44 vs. 11.6 ml/hour, respectively), with less variation in NIDUS than CVVH (SDs 3.2 vs. 28.4 ml/hour). Biochemical clearances The initial intention was to compare clearance rate on NIDUS with the control group. However, for these variables combining PD and CVVH in this way proved to be misleading because NIDUS clearances rates were intermediate between those of PD and CVVH. The clearance for creatinine on PD was smaller and less variable (mean 0.08, SD 0.03 ml/min/kg) than on the NIDUS (mean 0.46, SD 0.30 ml/min/kg), which was in turn smaller and less variable than for CVVH (mean 1.20, SD 0.72 ml/min/kg). The pattern was repeated for urea: PD (0.12, 0.06), NIDUS (0.48, 0.30) and CVVH (1.15, 0.67), all in ml/min/kg, and also for phosphate: PD (0.07, 0.04), NIDUS (0.44, 0.27) and CVVH (1.16, 0.71), all in ml/min/kg. All pairwise treatment comparisons of means and of SDs gave p < 0.001. More detail on the UF and clearances are provided in the results section of the main report. Survival Of the 62 participants receiving control treatment, 54 survived to 30 days (87%) and 52 (84%) survived until discharge. For the 35 participants in the NIDUS group, 25 survived to 30 days (71%) and 23 (66%) survived to discharge. For the participants receiving PD 47 of 48 participants (98%) survived to 30 days, and 46 (96%) survived to discharge, whereas for the 13 participants on CVVH the corresponding values were 7 (54%) and 6 (46%). The participant receiving ECMO plus haemodialysis is not included in these figures. Exposure to blood transfusion while on renal replacement treatment Median (IQR) haemoglobin concentrations prior to starting renal replacement treatment were similar. However, only 7 (15%) of the participants on PD required a blood transfusion, whereas 12 (92%) of the 13 on CVVH required blood transfusion and 27 (77%) of those on NIDUS required blood transfusion. Five of the ten babies, whose CVVH circuits were via conventional central venous access lines, required priming with blood rather than saline, but none of the NIDUS circuits needed this. Use of inotropes or fluid bolus Hundred per cent of participants on PD, seventy-seven per cent of those on CVVH and eighty-nine per cent of those on NIDUS were reported as receiving additional fluid bolus (defined as 80 ml/kg by the PICANet) or inotropes infusion in the first 48 hours of renal replacement treatment. Safety reporting There were 27 adverse events (AEs) across 23 participants (15 control, 8 intervention). Adverse device events were only reported for the NIDUS intervention. There was one adverse device event which was possibly related to the NIDUS device/tubing set. There were 17 serious adverse events across 15 participants (8 control, 7 intervention). One serious adverse device event was reported throughout the study. Conclusions The I-KID study provides important new information about renal replacement treatment in babies on PICUs. The results show that the UF obtained with the NIDUS was closer to that prescribed than with control. Moreover, the UF reported by the NIDUS was a reliable reflection of the true UF. Clinically both aspects are important. While measurement of UF with PD is easy and accurate, the uncontrollability and unpredictability of UF is clinically recognised as an issue. It is also very important to be able to rely on the information given by a dialysis/filtration device being accurate for the clinician to make appropriate adjustments to the patient’s overall fluid balance. Conversely, if the device gives inaccurate information to the clinical team it contributes to uncertainty and difficulty in overall fluid management. Manufacturers are aware of the inherent imprecision of their devices and give warnings in their technical documentation and indeed, concern regarding variability in fluid removal was the initial reason for licensing restriction of CVVH devices. There is currently only one device licensed for babies under 8 kg, the Cardio-Renal Pediatric Dialysis Emergency Machine (CARPEDIEM®) (Medtronic, www.medtronic.com), which was not in use in the UK during this study time and was not available for study in I-KID. The clearance comparison between PD and NIDUS reflects that found in a previous study, whereas this is the first comparison between CVVH (Prismaflex® and Aquarius®) and NIDUS. Given the greater blood flow and larger filter surface area of the CVVH devices, these results are as anticipated. Clinically, the NIDUS would provide adequate biochemical clearance for controlling biochemical disturbance in babies with acute renal failure. Many babies requiring renal replacement treatment in PICUs are critically unwell, as reflected by the vast majority of participants in I-KID having multi-organ failure; most were on positive pressure ventilatory support. There was a very high use of inotrope infusions, but it is unclear whether this was largely ‘routine use’ in babies postoperatively after cardiac surgery or related to hypotensive episodes. The survival data reflects the high mortality associated with the underlying clinical diagnoses. Mortality was lowest for PD and highest for CVVH, with NIDUS in between. Babies who are unwell and particularly post surgical may require blood transfusion for a number of different reasons. Few babies on PD required blood transfusion but rates were much higher in babies treated with CVVH and NIDUS. Those participants may have been more unwell or the process of haemofiltration and dialysis renal replacement treatment increases the need for blood transfusion. Half of the CVVH circuits connected to the babies’ central venous lines required blood priming, but none of the NIDUS circuits did. Recruitment was high in the first part of the study, when most participants were entering the control phase, but was less good as the study progressed and sites were mainly enrolling babies into the intervention phase. The study faced a number of challenges to delivery, including moratoria on non-COVID-19 research during the early phases of the COVID pandemic. The number of control cases on PD (vs. CVVH) was higher than we had estimated. There were AEs reported in both control subgroups and in intervention cases. NIDUS was shown to have an acceptable safety profile compared with other modalities used in this critically unwell population. Implications for health care The I-KID study had high input from public and parents at all stages from the early development phase onwards and this was crucial to ensuring acceptability to participant parents. Importantly, most parents who responded to the questionnaire indicated they felt it was acceptable to be approached about taking part in research despite the circumstances. This is important for future research studies in critical care. The study required and achieved a high degree of support from clinicians and nursing staff. An important safety profile has been created and user feedback from I-KID has provided vital information on improvements required to NIDUS to improve usability. Peritoneal dialysis is likely to remain a commonly used technique for babies with less severe renal failure who require less intensive dialysis. Many postoperative babies (especially those undergoing cardiac surgery) have a PD catheter inserted during surgery, which is sometimes just used for draining ascitic fluid and can be easily used for dialysis if required. However, insertion of a PD catheter is not without its risks, and there is room for future studies questioning the best immediate postoperative renal support modality. Where PD is not possible or fails, it is clear that NIDUS provides a good therapeutic option to be considered. Largely the results were in concordance with clinical experience of renal replacement treatment in babies and with previous NIDUS animal and compassionate use reports. The results show that the intervention device, NIDUS, works effectively delivering appropriate blood clearances and accurate, controllable fluid removal (UF), with an appropriate safety profile, indicating that it has an important place alongside other dialysis modalities in the management of babies with renal failure. Trial registration This trial is registered as ISRCTN 13787486. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Efficacy and Mechanism Evaluation Programme (NIHR award ref: 14/23/26) and is published in full in Efficacy and Mechanism Evaluation; Vol. 11, No. 1. See the NIHR Funding and Awards website for further award information.

Simulation educators are often requested to provide multidisciplinary and/or interprofessional simulation training in response to critical incidents. Current perspectives on patient safety focus on learning from failure, success and everyday variation. An international collaboration has led to the development of an accessible and practical framework to guide the implementation of appropriate simulation-based responses to clinical events, integrating quality improvement, simulation and patient safety methodologies to design appropriate and impactful responses. In this article, we describe a novel five-step approach to planning simulation-based interventions after any events that might prompt simulation-based learning in healthcare environments. This approach guides teams to identify pertinent events in healthcare, involve relevant stakeholders, agree on appropriate change interventions, elicit how simulation can contribute to them and share the learning without aggravating the second victim phenomenon. The framework is underpinned by Deming's System of Profound Knowledge, the Model for Improvement and translational simulation. It aligns with contemporary socio-technical models in healthcare, by emphasising the role of clinical teams in designing adaptation and change for improvement, as well as encouraging collaborations to enhance patient safety in healthcare. For teams to achieve this adaptive capacity that realises organisational goals of continuous learning and improvement requires the breaking down of historical silos through the creation of an infrastructure that formalises relationships between service delivery, safety management, quality improvement and education. This creates opportunities to learn by design, rather than chance, whilst striving to close gaps between work as imagined and work as done.

Objectives:Renal replacement therapy (RRT) options are limited for small babies because of lack of available technology. We investigated the precision of ultrafiltration, biochemical clearances, clinical efficacy, outcomes, and safety profile for a novel non-Conformite Europeenne-marked hemodialysis device for babies under 8 kg, the Newcastle Infant Dialysis Ultrafiltration System (NIDUS), compared with the current options of peritoneal dialysis (PD) or continuous venovenous hemofiltration (CVVH). Design:Nonblinded cluster-randomized cross-sectional stepped-wedge design with four periods, three sequences, and two clusters per sequence. Setting:Clusters were six U.K. PICUs. Patients:Babies less than 8 kg requiring RRT for fluid overload or biochemical disturbance. Interventions:In controls, RRT was delivered by PD or CVVH, and in interventions, NIDUS was used. The primary outcome was precision of ultrafiltration compared with prescription; secondary outcomes included biochemical clearances. Measurements and Main Results:At closure, 97 participants were recruited from the six PICUs (62 control and 35 intervention). The primary outcome, obtained from 62 control and 21 intervention patients, showed that ultrafiltration with NIDUS was closer to that prescribed than with control: sd controls, 18.75, intervention, 2.95 (mL/hr); adjusted ratio, 0.13; 95% CI, 0.03-0.71; p = 0.018. Creatinine clearance was smallest and least variable for PD (mean, sd) = (0.08, 0.03) mL/min/kg, larger for NIDUS (0.46, 0.30), and largest for CVVH (1.20, 0.72). Adverse events were reported in all groups. In this critically ill population with multiple organ failure, mortality was lowest for PD and highest for CVVH, with NIDUS in between. Conclusions:NIDUS delivers accurate, controllable fluid removal and adequate clearances, indicating that it has important potential alongside other modalities for infant RRT.

Objectives The aim of the Emergency Triage Assessment and Treatment (ETAT) plus trauma course is to improve the quality of care provided to infants and children younger than 5 years. The curriculum was revised and shortened from 5 to 2.5 days by enhancing simulation and active learning opportunities. The aim of this study was to examine the feasibility and value of the new short-form ETAT course by assessing postcourse knowledge and satisfaction. Methods We delivered the short-form ETAT course to a group of interdisciplinary health workers in Malawi. Precourse and postcourse knowledge was assessed using a standardized 20 questions short answer test used previously in the 5-day courses. A 13-statement survey with 2 open-ended questions was used to examine participant satisfaction. Results Participants' postcourse knowledge improved significantly (P < 0.001) after the shorter ETAT course. Participants reported high levels of satisfaction with the short-form ETAT. Conclusions Simulation and other active learning strategies reduced training time by 50% in the short-form ETAT course. Participants with and without previous ETAT training improved their knowledge after participating in the short-form ETAT course. Reduced training time is beneficial in settings already burdened by scarce human resources, may facilitate better access to in-service training, and build capacity while conserving resources in low-resource settings.

A pandemic has sent the world into chaos. It has not only upended our lives; hundreds of thousands of lives have already been tragically lost. The global crisis has been disruptive, even a threat, to healthcare simulation, affecting all aspects of operations from education to employment. While simulationists around the world have responded to this crisis, it has also provided a stimulus for the continued evolution of simulation. We have crafted a manifesto for action, incorporating a more comprehensive understanding of healthcare simulation, beyond tool, technique or experience, to understanding it now as a professional practice. Healthcare simulation as a practice forms the foundation for the three tenets comprising the manifesto: safety, advocacy and leadership. Using these three tenets, we can powerfully shape the resilience of healthcare simulation practice for now and for the future. Our call to action for all simulationists is to adopt a commitment to comprehensive safety, to advocate collaboratively and to lead ethically.

Objectives: Crisis resource management principles dictate appropriate distribution of mental and/or physical workload so as not to overwhelm any one team member. Workload during pediatric emergencies is not well studied. The National Aeronautics and Space Administration-Task Load Index is a multidimensional tool designed to assess workload validated in multiple settings. Low workload is defined as less than 40, moderate 40–60, and greater than 60 signify high workloads. Our hypothesis is that workload among both team leaders and team members is moderate to high during a simulated pediatric sepsis scenario and that team leaders would have a higher workload than team members. Design: Multicenter observational study. Setting: Nine pediatric simulation centers (five United States, three Canada, and one United Kingdom). Patients: Team leaders and team members during a 12-minute pediatric sepsis scenario. Interventions: National Aeronautics and Space Administration-Task Load Index. Measurements and Main Results: One hundred twenty-seven teams were recruited from nine sites. One hundred twenty-seven team leaders and 253 team members completed the National Aeronautics and Space Administration-Task Load Index. Team leader had significantly higher overall workload than team member (51 ± 11 vs 44 ± 13; p < 0.01). Team leader had higher workloads in all subcategories except in performance where the values were equal and in physical demand where team members were higher than team leaders (29 ± 22 vs 18 ± 16; p < 0.01). The highest category for each group was mental 73 ± 13 for team leader and 60 ± 20 for team member. For team leader, two categories, mental (73 ± 17) and effort (66 ± 16), were high workload, most domains for team member were moderate workload levels. Conclusions: Team leader and team member are under moderate workloads during a pediatric sepsis scenario with team leader under high workloads (> 60) in the mental demand and effort subscales. Team leader average significantly higher workloads. Consideration of decreasing team leader responsibilities may improve team workload distribution.

Objectives: Pauses in cardiopulmonary resuscitation negatively impact clinical outcomes; however, little is known about the contributing factors. The objective of this study is to determine the frequency, duration, and causes for pauses during cardiac arrest. Design: This is a secondary analysis of video data collected from a prospective multicenter trial. Twenty-six simulated pediatric cardiac arrest scenarios each lasting 12 minutes in duration were analyzed by two independent reviewers to document events surrounding each pause in chest compressions. Setting: Ten children’s hospitals across Canada, the United, and the United Kingdom. Subjects: Resuscitation teams composed of three healthcare providers trained in cardiopulmonary resuscitation. Interventions: A simulated pediatric cardiac arrest case in a 5 year old. Measurements and Main Results: The frequency, duration, and associated factors for each pause were recorded. Communication was rated using a four-point scale reflecting the team’s shared mental model. Two hundred fifty-six pauses were reviewed with a median of 10 pauses per scenario (interquartile range, 7–12). Median pause duration was 5 seconds (interquartile range, 2–9 s), with 91% chest compression fraction per scenario (interquartile range, 88–94%). Only one task occurred during most pauses (66%). The most common tasks were a change of chest compressors (25%), performing pulse check (24%), and performing rhythm check (15%). Forty-nine (19%) of the pauses lasted greater than 10 seconds and were associated with shock delivery (p < 0.001), performing rhythm check (p < 0.001), and performing pulse check (p < 0.001). When a shared mental model was rated high, pauses were significantly shorter (mean difference, 4.2 s; 95% CI, 1.6–6.8 s; p = 0.002). Conclusions: Pauses in cardiopulmonary resuscitation occurred frequently during simulated pediatric cardiac arrest, with variable duration and underlying causes. A large percentage of pauses were greater than 10 seconds and occurred more frequently than the recommended 2-minute interval. Future efforts should focus on improving team coordination to minimize pause frequency and duration.

This chapter discusses how pediatric simulation should evolve in the future to best address the needs of pediatric patients and their families. The chapter specifically highlights several key areas that offer opportunity for the future: (1) optimizing simulation resources within and between programs to enhance productivity, (2) integration of simulation into clinical governance, family-centered care, and assessment of healthcare professionals, (3) innovation in the forms of asynchronous learning, improved education management systems, distance learning, and improving the safety of clinical environments, (4) investigating pertinent clinical questions using simulation as a research tool, and (5) inspiring the future generation of simulation leaders by establishing a vision of how simulation can be used as a tool to enhance education, research, and patient safety.

Aim: The variability in quality of CPR provided during cardiac arrest across pediatric institutions is unknown. We aimed to describe the degree of variability in the quality of CPR across 9 pediatric institutions, and determine if variability across sites would be affected by Just-in-Time CPR training and/or visual feedback during simulated cardiac arrest.Methods: We conducted secondary analyses of data collected from a prospective, multi-center trial. Participants were equally randomized to either: (1) No intervention; (2) Real-time CPR visual feedback during cardiac arrest or (3) Just-in-Time CPR training. We report the variability in median chest compression depth and rate across institutions, and the variability in the proportion of 30-s epochs of CPR meeting 2010 American Heart Association guidelines for depth and rate.Result: We analyzed data from 528 epochs in the no intervention group, 552 epochs in the visual feedback group, and 525 epochs in the JIT training group. In the no intervention group, compression depth (median range 22.2-39.2 mm) and rate (median range 116.0-147.6 min(-1)) demonstrated significant variability between study sites (p < 0.001). The proportion of compressions with adequate depth (0-11.5%) and rate ( 0-60.5%) also varied significantly across sites (p < 0.001). The variability in compression depth and rate persisted despite use of real-time visual feedback or JIT training (p < 0.001).Conclusion: The quality of CPR across multiple pediatric institutions is variable. Variability in CPR quality across institutions persists even with the implementation of a Just-in-Time training session and visual feedback for CPR quality during simulated cardiac arrest. (C) 2015 Elsevier Ireland Ltd. All rights reserved.

Hypothesis Each year, cardiopulmonary resuscitation (CPR) is provided for thousands of children in North America.1-2 Quality of CPR directly impacts hemodynamics, survival, and neurologic outcome following cardiac arrest.3-4 Unfortunately, well-trained healthcare providers fail to consistently perform CPR within established American Heart Association (AHA) guidelines.5-8 Just-in-Time (JIT) bedside CPR practice with audiovisual feedback improves compliance with AHA guidelines on manikins and real children during cardiopulmonary arrest (CPA).9-10 CPR feedback devices provide visual and/or auditory feedback during CPA, and have been shown to improve the quality of CC when used during training11 and during CPA events.12 We sought to determine whether JIT CPR Training with visual feedback (VisF) before CPA and/or real-time VisF during CPA improves quality of CPR during simulated CPA. Methods We conducted a prospective, randomized, 2x2 factorial trial with explicit methodology.13 Ten International Network for Simulation-based Pediatric Innovation, Research and Education (INSPIRE) simulation programs participated by running standardized 12-minute simulated CPAs from July 2012 to April 2014. We recruited 324 pediatric CPR certified healthcare providers, assigned to 3-person resuscitation teams (n =108 teams). Our two interventions were: a) “Just-in-Time” standardized, brief CPR training with video and VisF before simulated CPA; and b) Real-Time VisF during simulated CPA. Each team was randomized to one of four permutations of JIT-CPR VisF training versus no JIT-CPRVisF training before CPA, and real-time VisF versus no real-time VisF during simulated CPA. Our main outcome measures were: proportion of chest compressions (CC) with depth > 50mm, proportion of CPR time with CC rate 100-120/min, and CC fraction (CCF, % of CPR time) for each simulated CPA event. Results We used a 2x2 factorial analysis to assess the effects of JIT CPR training and/or VisF on the primary and secondary outcome measures. The quality of CPR was poor in the control group, with 12.7% (95% CI: 5.2, 20.1%) mean CC depth compliance and 27.1% (95% CI: 14.2, 40.1%) mean CC rate compliance. JIT-CPR VisF Training, compared to no JIT-CPR VisF training, improved CC depth compliance by 19.9% (95% CI: 11.1, 28.7%; p <0.001) and CC rate compliance by 12.0% (95% CI: 0.8, 23.2%; p=0.037). Real-time VisF, compared to no real-time VisF, improved CC depth compliance by 15.4% (95% CI: 6.6, 24.2%; p value = 0.001) and CC rate compliance by 40.1% (95% CI: 28.8, 51.3%; p< 0.001). Neither intervention had a statistically significant effect on CCF, which was excellent (>89%) in all groups. Combining both interventions showed the highest compliance with AHA guidelines, but was not significantly better than either intervention in isolation. Conclusion The quality of CPR provided by healthcare providers is poor. It is feasible to improve CPR quality using a simple visual CPR quality feedback device during JIT CPR training (with video) or during a simulated CPA event (real-time feedback). JIT CPR VisF training and/or “real-time” VisF during CPR can improve compliance with AHA guidelines for CPR quality that are associated with improved survival outcomes. References 1. Parra DA, Totapally BR, Zahn E, et al. Outcome of cardiopulmonary resuscitation in a pediatric cardiac arrest unit. Crit Care Med. 2000; 28:3296-300. 2. Slonim AD, Patel KM, Ruttimann UE, Pollack MM. Cardiopulmonary resuscitation in pediatric intensive care units. Crit Care Med. 1997; 25:1951-5. 3. Cheskes S, Schmicker RH, Christenson J, et al. Perishock pause: an independent predictor of survival from out-of-hospital shockable cardiac arrest. Circulation. 2011; 124:58-66. 4. Christenson J, Andrusiek D, Everson-Stewart S, et al. Chest compression fraction determines survival in patients with out-of-hospital ventricular fibrillation. Circulation. 2009; 120:1241-7. 5. Kaye W, Mancini ME. Retention of cardiopulmonary resuscitation skills by physicians, registered nurses, and the general public. Crit Care Med. 1986;14:620-622. 6. Broomfield R. A quasi-experimental research to investigate the retention of basic cardioKpulmonKary resuscitation skills and knowledge by qualified nurses following a course in professional development. J Adv Nurs. 1996; 23:1016-1023. 7. Abella B, Becker L, et al. Quality of cardiopulmonary resuscitation during in-hospital cardiac arrest. JAMA. 2005; 293:305-310. 8. Wik L, Kramer-Johansen, Myklebust H, et al. Quality of cardiopulmonary resuscitation during out-of-hospital cardiac arrest. JAMA. 2005; 293:305-310. 9. Niles D, Donoghue A, Kalsi MS et al. “Rolling Refreshers”: a novel approach to maintain CPR psychomotor skill competence. Resuscitation. 2009;80:909-12. 10. Sutton RM, Niles D, Meaney PA et al. “Booster” training: evaluation of instructor-led bedside cardiopulmonary resuscitation skill training and automated corrective feedback to improve cardiopulmonary resuscitation compliance of pediatric basic life support providers during simulated cardiac arrest. Pediatr Crit Care Med. 2011;12:e116-21. 11. Yeung J, Meeks R, Edelson D, Gao F, Soar J, Perkins GD. The use of CPR feedback/prompt devices during training and CPR performance: a systematic review. Resuscitation. 2009;80:743-51. 12. Kirkbright S, Finn J, Tohira H, Bremner A, Jacobs I, Celenza A. Audiovisual feedback device use by health care professionals during CPR: A systematic review and meta-analysis of randomized and non-randomised trials. Resuscitation. 2014; 85:460-71. 13. Cheng A, Auerbach M, Chang T, Hunt EA, Pusic M, Nadkarni V, Kessler D. Designing and Conducting Simulation-based Research. [Published online May 12, 2014]. Pediatrics. Doi: 10.1542/peds.2013-3267. Disclosures Adam Cheng receives grant support from the Heart and Stroke Foundation of Canada, and the Canadian Institute for Health Research. Vincent Grant serves on the Board of Directors and is a stockholder for PACEWellness. David Kessler is a consultant for SonoSim. Vinay Nadkarni receives grant support from Laerdal Foundation, Laerdal Corporation, Nihon-Kohden Corporation; Zoll Corporation, and the Zoll Foundation. Nancy Tofil spoke at a Laerdal Conference, presenting her own original material. She did not receive honoraria, but was reimbursed travel expenses.

IMPORTANCE The quality of cardiopulmonary resuscitation (CPR) affects hemodynamics, survival, and neurological outcomes following pediatric cardiopulmonary arrest (CPA). Most health care professionals fail to perform CPR within established American Heart Association guidelines. OBJECTIVE To determine whether "just-in-time" (JIT) CPR training with visual feedback (VisF) before CPA or real-time VisF during CPA improves the quality of chest compressions (CCs) during simulated CPA. DESIGN, SETTING, AND PARTICIPANTS Prospective, randomized, 2 × 2 factorial-design trial with explicit methods (July 1, 2012, to April 15, 2014) at 10 International Network for Simulation-Based Pediatric Innovation, Research, & Education (INSPIRE) institutions running a standardized simulated CPA scenario, including 324 CPR-certified health care professionals assigned to 3-person resuscitation teams (108 teams). INTERVENTIONS Each team was randomized to 1 of 4 permutations, including JIT training vs no JIT training before CPA and real-time VisF vs no real-time VisF during simulated CPA. MAIN OUTCOMES AND MEASURES The proportion of CCs with depth exceeding 50 mm, the proportion of CPR time with a CC rate of 100 to 120 per minute, and CC fraction (percentage CPR time) during simulated CPA. RESULTS The quality of CPR was poor in the control group, with 12.7% (95% CI, 5.2%-20.1%) mean depth compliance and 27.1% (95% CI, 14.2%-40.1%) mean rate compliance. JIT training compared with no JIT training improved depth compliance by 19.9% (95% CI, 11.1%-28.7%; P < .001) and rate compliance by 12.0% (95% CI, 0.8%-23.2%; P = .037). Visual feedback compared with no VisF improved depth compliance by 15.4% (95% CI, 6.6%-24.2%; P = .001) and rate compliance by 40.1% (95% CI, 28.8%-51.3%; P < .001). Neither intervention had a statistically significant effect on CC fraction, which was excellent (>89.0%) in all groups. Combining both interventions showed the highest compliance with American Heart Association guidelines but was not significantly better than either intervention in isolation. CONCLUSIONS AND RELEVANCE The quality of CPR provided by health care professionals is poor. Using novel and practical technology, JIT training before CPA or real-time VisF during CPA, alone or in combination, improves compliance with American Heart Association guidelines for CPR that are associated with better outcomes. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT02075450.

Introduction/Background Malawi has among the highest pediatric mortality rates in the world, exceeding 120 deaths/1000 admissions in some hospitals.1,2 Fifty to eighty two percent of these deaths occur within 48 hours of admission2,3 and many are attributable to deficiencies in the care received by critically ill children, which may in part be due to inadequate health worker training.2 Recent introduction of educational programs, such as Emergency Triage Assessment and Treatment (ETAT) have reduced mortality by 10% at some centers.3 As ETAT incorporates elements of simulation, national interest in developing simulation training capacity has grown. At the request of the Malawi Ministry of Health (MMoH), members of the International Pediatric Simulation Society (IPSS) have evaluated ETAT, to delineate strengths and weaknesses in simulation pedagogy within the program, and identify opportunities and threats to the development of simulation-based education in the country. Methods An eight person multidisciplinary team of simulation experts from IPSS travelled to Malawi in May 2013 to conduct the evaluation. A utilization focused evaluation framework known as the Context, Input, Process, Product (CIPP)4 model was adopted to guide the process. For each CIPP element, multiple data sources were collected, including field notes and interviews with stakeholders completed during site visits to the MMoH, central and district hospitals, rural healthcare centers and both medical and nursing training colleges; direct observations of an ETAT course; and follow up interviews with faculty and participants. Borrowing on the SWOT (strengths, weaknesses, opportunities and threats) matrix,5 data were organized as drivers (strengths and opportunities) or barriers (weaknesses and threats). Our evaluation revealed that although simulation is incorporated as an educational tool within ETAT, it may be significantly underutilized. Evaluation of context identified primary drivers to be buy in from the MMoH for national scale-up of ETAT and support from faculty for revising the curriculum to align with simulation best practices. Barriers included high patient volumes and staff shortages, limiting time for faculty and participants to attend ETAT training. However, this was also identified as an opportunity to incorporate in-situ simulation into ETAT. The evaluation of input identified access to simulation materials (e.g. mannequins, animal models and patients for ‘clinical practice’) to meet educational needs as a driver. Conversely, the increasing number of trainees and limited number of trainers were identified as barriers. Drivers identified during process evaluation included passionate faculty keenly interested in developing their simulation skills, opportunities for interprofessional education and team training (given ETAT is delivered in an interdisciplinary fashion) and dedicated moments for simulation training within the course. Barriers included lack of faculty training in simulation pedagogy, resulting in limited scenario based training, no debriefing and failure to facilitate deliberate practice.6 Finally, product evaluation revealed that participants perceived ETAT training significantly improved their skills. However, severe clinical resource shortages, resulting in a mismatch between what participants are taught and what they can deliver was identified as a significant barrier to subsequent improvement in pediatric outcomes. Results: Conclusion Recent evidence suggests training health workers through educational programs incorporating simulation significantly impacts pediatric mortality, supporting arguments for capacity development of simulation in Malawi. Our evaluation reveals faculty development and enhancement of simulation pedagogy within ETAT are the most pressing needs in this regard. This may be facilitated through a ‘train the trainers’ program focused on best practices in simulation.7 We are currently developing such a program, with anticipated rollout in 2014. Subsequent evaluation of its impact on the delivery and effectiveness of future ETAT courses is planned. Once a highly trained cadre of simulation educators has been established, development of programs beyond ETAT (e.g. in-situ simulation in healthcare facilities) may be explored. However, in such low resource settings, educational content must be appropriately matched to the realities of clinical practice. References 1. You D, New JR, Wardlaw T: Levels & Trends in Child Mortality. New York, NY: United Nations Children’s Fund 2012; 1-32. Available at: http://www.childinfo.org/files/Child_Mortality_Report_2012.pdf. 2. Lufesi N: Assessment of Hospital Based Child Care Services in Malawi: Final Report. Malawi Ministry of Health Acute Respiratory Infections Control Program; 2010:1-42. 3. Robison JA, Ahmad ZP, Nosek CA, Durand C, Namathanga A, Milazi R, Thomas A, Soprano JV, Mwansambo C, Kazembe PN, Torrey SB: Decreased Pediatric Hospital Mortality After an Intervention to Improve Emergency Care in Lilongwe, Malawi. PEDIATRICS 2012; 130(3):e676-82. 4. Stufflebeam D: The CIPP model for program evaluation, Evaluation models: Viewpoints on educational and human services evaluation. Edited by Madaus G, Scriven M, Stufflebeam D. Boston, Kluwer-Nijhoff, 1983, pp 117-41. 5. Gordon J, Hazlett C, Cate Ten O, Mann K, Kilminster S, Prince K, O’Driscoll E, Snell L, Newble D: Strategic planning in medical education: enhancing the learning environment for students in clinical settings. Medical Education 2000; 34(10):841-850. 6. McGaghie WC, Issenberg SB, Cohen ER, Barsuk JH, Wayne DB: Does Simulation-Based Medical Education With Deliberate Practice Yield Better Results Than Traditional Clinical Education? A Meta-Analytic Comparative Review of the Evidence. Academic Medicine. 2011;86(6):706-711. 7. Dorman K, Derbew M, Henok F, Desalegn D, Dubrowski A, Satterthwaite L, Pittini R, Tajirian T, Kneebone R, Bello F, Byrne N: A Training Cascade for Interprofessional Surgical and Obstetrical Care in Ethiopia. In: 2012 Abstracts, Canadian Conference on Global Health 2012: 29. Disclosures Royal College of Physicians and Surgeons of Canada Fellowship for Studies in Medical Education

As the time available for medical education is shortened by reductions in training hours and the demands of modern healthcare delivery, educators are increasingly looking towards simulation as a means of providing safe and reproducible situations for clinical skills teaching, decision-making and team training. The tools available for simulation-based training have developed rapidly over the past 15 years. There is an increasing range of manikins and part-task trainers - devices that permit selected elements of a skill or task to be practised independently of a whole-body manikin. Those interested in simulation have also focused significantly on adult learning theory to ensure that the training offered through simulation is appropriate, effective and complementary to other educational approaches. By mapping simulated scenarios to the Royal College of Paediatrics and Child Health Curriculum for General Paediatric Training at Level 1, the authors have developed two complementary courses aimed at preparing the general paediatric trainee for progression to the middle grade role. It is hoped that such approaches will become integral to paediatric training in the future.

As the time available for medical education is shortened by reductions in training hours and the demands of modern healthcare delivery, educators are increasingly looking towards simulation as a means of providing safe and reproducible situations for clinical skills teaching, decision-making and team training. The tools available for simulation-based training have developed rapidly over the past 15 years. There is an increasing range of manikins and part-task trainers – devices that permit selected elements of a skill or task to be practised independently of a whole-body manikin. Those interested in simulation have also focused significantly on adult learning theory to ensure that the training offered through simulation is appropriate, effective and complementary to other educational approaches. By mapping simulated scenarios to the Royal College of Paediatrics and Child Health Curriculum for General Paediatric Training at Level 1, the authors have developed two complementary courses aimed at preparing the general paediatric trainee for progression to the middle grade role. It is hoped that such approaches will become integral to paediatric training in the future.

Aims. To outline the etiology, clinical course, short-term survival to discharge and neurological outcome of infants (<1 yr) with new cardiac diagnoses presenting to a pediatric intensive care (PICU) unit with acute cardiac compromise.Methods. Retrospective search of a computerized database and medical case notes for all acute cardiac admissions to PICU from June 2001 to 2006. Pre-existing hospital-based patients with new cardiac diagnoses were excluded.Results. Seventy patients were identified, 38 (54%) of whom were male. There were six main subgroups: obstructive left heart lesions (n = 20), transposition of the great arteries (TGA) (n = 9), total anomalous pulmonary venous drainage (TAPVD) (n = 7), dilated cardiomyopathy (n = 11), arrhythmia (n = 12), and others (n = 11). Fifty-nine patients (84%) were external referrals to our center. The median age at presentation was 13.5 days (0-272) with median duration of symptoms of 1 day (0-21). The median base deficit at presentation was -7.6 mEq/L (-43 to +4.2). Fifty-three patients (76%) required respiratory support with a median duration of ventilation of 4 days (1-49). Fifty-six patients (80%) required inotropic support. The median PICU stay was 7 days (1-64) with a median total hospital stay of 16 days (1-71). Six patients (9%) died prior to discharge. Of the survivors 7 (11%) had seizure activity or evolving clinical neurological abnormalities.Conclusions. Cardiovascular compromise due to previously unrecognized congenital or acquired heart disease is associated with clinically significant morbidity and mortality. Longer term follow-up is required to evaluate the initial effect of poor cardiac output and hypoxia on long-term neurodevelopmental outcome.

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OBJECTIVES:Acidosis caused by increased unmeasured anion levels occurs frequently after cardiac surgery, with uncertain significance. We examined the ability of unmeasured anions and lactate to predict major events after cardiac surgery, in addition to lactate/increased unmeasured anion levels during low cardiac output states.METHODS:In the initial 6 months, all patients admitted after cardiac surgery were enrolled. Arterial samples were taken at 0, 4, 8, 12, 24, and 36 hours postoperatively. The Stewart method was used to calculate excess acid and unmeasured anion levels. Major adverse events were defined as low cardiac output states requiring cardiac massage or mechanical support. In the second 6-month period, data were collected from a further 8 infants during cardiac arrest/extracorporeal membrane oxygenation cannulation.RESULTS:One hundred thirteen patients were analyzed. Major adverse events occurred in 8 (7.1%) of 113 patients. On admission, metabolic acidosis occurred in 94 of 113 samples: lactate alone (n = 25); mixed lactate and unmeasured anions (n = 44); and unmeasured anions alone (n = 25). All of the patients who experienced major adverse events had unmeasured anion levels of greater than 3 mEq/L on admission. Initial unmeasured anion levels were significantly higher in those infants with major adverse events (10.6 mEq/L [standard deviation, 8.2 mEq/L] vs 4.8 mEq/L [standard deviation, 6.6 mEq/L], P = .024). Lactate levels did not differ between the 2 groups. In the 16 patients sampled during major adverse events, metabolic acidosis occurred in 15 of 16, with a mean excess acid level of 14.9 mEq/L (standard deviation, 8.3 mEq/L). Although unmeasured anions made a significant contribution, lactate was the predominant acid.CONCLUSIONS:After cardiac surgery, unmeasured anion levels were significantly higher in those children with major adverse events. The greatest risk of major adverse events was found in children with both increased lactate levels and increased unmeasured anion levels on admission.