Developing a generalizable pediatric ECMO emergency checklist for clinical specialist: Progress and challenges.

INTRODUCTION: Extracorporeal membrane oxygenation (ECMO) emergencies require skilled clinical specialist (CS) who manage ECMO circuits. While tools for assessing CS skills have been published, there is significant variation in protocols and circuit design. This study aims to further develop these checklists to produce a generalizable ECMO skill assessment with adequate validity evidence to support its use as a summative evaluation tool. METHODS: An initial survey determined variation in ECMO circuit components and configurations, and the original checklists and simulations were altered through a modified Delphi process. The finalized checklist and simulation were then assessed for validity and reliability. Three trained raters assessed ten simulations from five subjects at two different institutions using two circuit designs. Data analysis was conducted using a fully crossed subject x rater x circuit generalizability (G) and decision (D) study. RESULTS: The G-study coefficient was 0 with 0% variance across subject and circuit. The greatest variance was among raters (28.7%). Significant variance was also associated with the subject and pump type relationship (27%). CONCLUSION: Despite the rigorous process used to modify the assessment, generalizability was poor. Lack of familiarity with center-specific circuit design played a key role. Future endeavors in ECMO skill assessment should focus either on developing and validating site-specific tools or standardizing circuit designs.

Associations With Severe Desaturation Events Among Children Receiving Noninvasive Respiratory Support at Time of Intubation.

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 [Formula: see text] < 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 [Formula: see text] ≥ 0.6 at the time of the decision to intubate (19.6%) versus [Formula: see text] < 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 [Formula: see text] > 0.60, the duration of noninvasive respiratory support, and exposure to NIV before an intubation are risk factors of severe desaturation events during intubation.

Association Between Mortality and Ventilator Parameters in Children With Respiratory Failure on ECMO.

BACKGROUND: In refractory respiratory failure, extracorporeal membrane oxygenation (ECMO) is a rescue therapy to prevent ventilator-induced lung injury. Optimal ventilator parameters during ECMO remain unknown. Our objective was to describe the association between mortality and ventilator parameters during ECMO for neonatal and pediatric respiratory failure. METHODS: We performed a secondary analysis of the Bleeding and Thrombosis on ECMO dataset. Ventilator parameters included breathing frequency, tidal volume, peak inspiratory pressure, PEEP, dynamic driving pressure, pressure support, mean airway pressure, and FIO2 . Parameters were evaluated before cannulation, on the calendar day of ECMO initiation (ECMO day 1), and the day before ECMO separation. RESULTS: Of 237 included subjects analyzed, 64% were neonates, of whom 36% had a congenital diaphragmatic hernia. Of all the subjects, 67% were supported on venoarterial ECMO. Overall in-hospital mortality was 35% (n = 83). The median (interquartile range) PEEP on ECMO day 1 was 8 (5.0-10.0) cm H2O for neonates and 10 (8.0-10.0) cm H2O for pediatric subjects. By multivariable analysis, higher PEEP on ECMO day 1 in neonates was associated with lower odds of in-hospital mortality (odds ratio 0.77, 95% CI 0.62-0.92; P = .01), with a further amplified effect in neonates with congenital diaphragmatic hernia (odds ratio 0.59, 95% CI 0.41-0.86; P = .005). No ventilator type or parameter was associated with mortality in pediatric subjects. CONCLUSIONS: Avoiding low PEEP on ECMO day 1 for neonates on ECMO may be beneficial, particularly those with a congenital diaphragmatic hernia. No additional ventilator parameters were associated with mortality in either neonatal or pediatric subjects. PEEP is a modifiable parameter that may improve neonatal survival during ECMO and requires further investigation.

Association of Ventilator Settings With Mortality in Pediatric Patients Treated With Extracorporeal Life Support for Respiratory Failure.

Extracorporeal life support (ECLS) is a treatment for acute respiratory failure that can provide extracorporeal gas exchange, allowing lung rest. However, while most patients remain mechanically ventilated during ECLS, there is a paucity of evidence to guide the choice of ventilator settings. We studied the associations between ventilator settings 24 hours after ECLS initiation and mortality in pediatric patients using a retrospective analysis of data from the Extracorporeal Life Support Organization Registry. 3497 patients, 29 days to 18 years of age, treated with ECLS for respiratory failure between 2015 and 2021, were included for analysis. 93.3% of patients on ECLS were ventilated with conventional mechanical ventilation. Common settings included positive end-expiratory pressure (PEEP) of 10 cm H 2 O (45.7%), delta pressure (ΔP) of 10 cm H 2 O (28.3%), rate of 10-14 breaths per minute (55.9%), and fraction of inspired oxygen (FiO 2 ) of 0.31-0.4 (30.3%). In a multivariate model, PEEP >10 cm H 2 O ( versus PEEP < 8 cm H 2 O, odds ratio [OR]: 1.53, 95% CI: 1.20-1.96) and FiO 2 ≥0.45 ( versus FiO 2 < 0.4; 0.45 ≤ FiO 2 < 0.6, OR: 1.31, 95% CI: 1.03-1.67 and FiO 2 ≥ 0.6, OR: 2.30; 95% CI: 1.81-2.93) were associated with higher odds of mortality. In a secondary analysis of survivors, PEEP 8-10 cm H 2 O was associated with shorter ECLS run times ( versus PEEP < 8 cm H 2 O, coefficient: -1.64, 95% CI: -3.17 to -0.11), as was ΔP >16 cm H 2 O ( versus ΔP < 10 cm H 2 O, coefficient: -2.72, 95% CI: -4.30 to -1.15). Our results identified several categories of ventilator settings as associated with mortality or ECLS run-time. Further studies are necessary to understand whether these results represent a causal relationship.

Analysis of Viscoelastic Testing in Pediatric Patients Using the Pediatric Extracorporeal Membrane Oxygenation Outcomes Registry.

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 χ2 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.

External validation of the Pediatric Extracorporeal Membrane Oxygenation Prediction model for risk adjusting mortality.

INTRODUCTION: The Pediatric Extracorporeal Membrane Oxygenation Prediction (PEP) model was created to provide risk stratification for all pediatric patients requiring extracorporeal life support (ECLS). Our purpose was to externally validate the model using contemporaneous cases submitted to the Extracorporeal Life Support Organization (ELSO) registry. METHODS: This multicenter, retrospective analysis included pediatric patients (<19 years) during their initial ECLS run for all indications between January 2012 and September 2014. Median values from the BATE dataset for activated partial thromboplastin time and internationalized normalized ratio were used as surrogates as these were missing in the ELSO group. Model discrimination was evaluated using area under the receiver operating characteristic curve (AUC), and goodness-of-fit was evaluated using the Hosmer-Lemeshow test. RESULTS: A total of 4,342 patients in the ELSO registry were compared to 514 subjects from the bleeding and thrombosis on extracorporeal membrane oxygenation (BATE) dataset used to develop the PEP model. Overall mortality was similar (42% ELSO vs. 45% BATE). The c-statistic after external validation decreased from 0.75 to 0.64 and model calibration decreases most in the highest risk deciles. CONCLUSION: Discrimination of the PEP model remains modest after external validation using the largest pediatric ECLS cohort. While the model overestimates mortality for the highest risk patients, it remains the only prediction model applicable to both neonates and pediatric patients who require ECLS for any indication and thus maintains potential for application in research and quality benchmarking.

The association between feeding protocol compliance and weight gain following high-risk neonatal cardiac surgery.

BACKGROUND: Children with congenital heart disease are at high risk for malnutrition. Standardisation of feeding protocols has shown promise in decreasing some of this risk. With little standardisation between institutions' feeding protocols and no understanding of protocol adherence, it is important to analyse the efficacy of individual aspects of the protocols. METHODS: Adherence to and deviation from a feeding protocol in high-risk congenital heart disease patients between December 2015 and March 2017 were analysed. Associations between adherence to and deviation from the protocol and clinical outcomes were also assessed. The primary outcome was change in weight-for-age z score between time intervals. RESULTS: Increased adherence to and decreased deviation from individual instructions of a feeding protocol improves patients change in weight-for-age z score between birth and hospital discharge (p = 0.031). Secondary outcomes such as markers of clinical severity and nutritional delivery were not statistically different between groups with high or low adherence or deviation rates. CONCLUSIONS: High-risk feeding protocol adherence and fewer deviations are associated with weight gain independent of their influence on nutritional delivery and caloric intake. Future studies assessing the efficacy of feeding protocols should include the measures of adherence and deviations that are not merely limited to caloric delivery and illness severity.

Use of Extracorporeal Membrane Oxygenation and Mortality in Pediatric Cardiac Surgery Patients With Genetic Conditions: A Multicenter Analysis.

OBJECTIVE: Congenital heart disease is commonly a manifestation of genetic conditions. Surgery and/or extracorporeal membrane oxygenation were withheld in the past from some patients with genetic conditions. We hypothesized that surgical care of children with genetic conditions has increased over the last decade, but their cardiac extracorporeal membrane oxygenation use remains lower and mortality greater. DESIGN: Retrospective cohort study. SETTING: Patients admitted to the Pediatric Health Information System database 18 years old or younger with cardiac surgery during 2003-2014. Genetic conditions identified by International Classification of Diseases, 9th Edition codes were grouped as follows: trisomy 21, trisomy 13 or 18, 22q11 deletion, and all "other" genetic conditions and compared with patients without genetic condition. PATIENTS: A total of 95,253 patients met study criteria, no genetic conditions (85%), trisomy 21 (10%), trisomy 13 or 18 (0.2%), 22q11 deletion (1%), and others (5%). INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Annual surgical cases did not vary over time. Compared to patients without genetic conditions, trisomy 21 patients, extracorporeal membrane oxygenation use was just over half (odds ratio, 0.54), but mortality with and without extracorporeal membrane oxygenation were similar. In trisomy 13 or 18 patients, extracorporeal membrane oxygenation use was similar to those without genetic condition, but all five treated with extracorporeal membrane oxygenation died. 22q11 patients compared with those without genetic condition had similar extracorporeal membrane oxygenation use, but greater odds of extracorporeal membrane oxygenation mortality (odds ratio, 3.44). Other genetic conditions had significantly greater extracorporeal membrane oxygenation use (odds ratio, 1.22), mortality with extracorporeal membrane oxygenation (odds ratio, 1.42), and even greater mortality odds without (odds ratio, 2.62). CONCLUSIONS: The proportion of children undergoing cardiac surgery who have genetic conditions did not increase during the study. Excluding trisomy 13 or 18, all groups of genetic conditions received and benefited from extracorporeal membrane oxygenation, although extracorporeal membrane oxygenation mortality was greater for those with 22q11 deletion and other genetic conditions.