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Item Executive Summary: International Clinical Practice Guidelines for Pediatric Ventilator Liberation, A PALISI Network Document(American Thoracic Society Journals, 2022-08-15) Abu-Sultaneh, Samer; Iyer, Narayan Prabhu; Fernández, Analía; Gaies, Michael; González-Dambrauskas, Sebastián; Hotz, Justin Christian; Kneyber, Martin C.J.; López-Fernández, Yolanda M.; Rotta, Alexandre T.; Werho, David K.; Baranwal, Arun Kumar; Blackwood, Bronagh; Craven, Hannah J.; Curley, Martha A.Q.; Essouri, Sandrine; Fioretto, Jose Roberto; Hartmann, Silvia M.M.; Jouvet, Philippe; Korang, Steven Kwasi; Rafferty, Gerrard F.; Ramnarayan, Padmanabhan; Rose, Louise; Tume, Lyvonne N.; Whipple, Elizabeth C.; Wong, Judith Ju Ming; Emeriaud, Guillaume; Mastropietro, Christopher W; Napolitano, Natalie; Newth, Christopher J.L.; Khemani, Robinder G.RATIONALE: Pediatric specific ventilator liberation guidelines are lacking despite the many studies exploring elements of extubation readiness testing. The lack of clinical practice guidelines has led to significant and unnecessary variation in methods used to assess pediatric patients' readiness for extubation. METHODS: Twenty-six international experts comprised a multi-professional panel to establish pediatric specific ventilator liberation clinical practice guidelines, focusing on acutely hospitalized children receiving invasive mechanical ventilation for more than 24 hours. Eleven key questions were identified and first prioritized using the Modified Convergence of Opinion on Recommendations and Evidence. Systematic review was conducted for questions which did not meet an a-priori threshold of ≥80% agreement, with Grading of Recommendations, Assessment, Development, and Evaluation methodologies applied to develop the guidelines. The panel evaluated the evidence, drafted, and voted on the recommendations. MEASUREMENTS AND MAIN RESULTS: Three questions related to systematic screening, using an extubation readiness testing bundle and use of a spontaneous breathing trial as part of the bundle met Modified Convergence of Opinion on Recommendations criteria of ≥80% agreement. For the remaining 8 questions, 5 systematic reviews yielded 12 recommendations related to the methods and duration of spontaneous breathing trials; measures of respiratory muscle strength; assessment of risk of post-extubation upper airway obstruction and its prevention; use of post-extubation non-invasive respiratory support; and sedation. Most recommendations were conditional and based on low to very low certainty of evidence. CONCLUSION: This clinical practice guideline provides a conceptual framework with evidence-based recommendations for best practices related to pediatric ventilator liberation.Item Executive Summary: International Clinical Practice Guidelines for Pediatric Ventilator Liberation, A Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network Document(American Thoracic Society, 2023) Abu-Sultaneh, Samer; Iyer, Narayan Prabhu; Fernández, Analía; Gaies, Michael; González-Dambrauskas, Sebastián; Hotz, Justin Christian; Kneyber, Martin C. J.; López-Fernández, Yolanda M.; Rotta, Alexandre T.; Werho, David K.; Baranwal, Arun Kumar; Blackwood, Bronagh; Craven, Hannah J.; Curley, Martha A. Q.; Essouri, Sandrine; Fioretto, Jose Roberto; Hartmann, Silvia M. M.; Jouvet, Philippe; Korang, Steven Kwasi; Rafferty, Gerrard F.; Ramnarayan, Padmanabhan; Rose, Louise; Tume, Lyvonne N.; Whipple, Elizabeth C.; Wong, Judith J. M.; Emeriaud, Guillaume; Mastropietro, Christopher W.; Napolitano, Natalie; Newth, Christopher J. L.; Khemani, Robinder G.; Pediatrics, School of MedicineRationale: Pediatric-specific ventilator liberation guidelines are lacking despite the many studies exploring elements of extubation readiness testing. The lack of clinical practice guidelines has led to significant and unnecessary variation in methods used to assess pediatric patients’ readiness for extubation. Methods: Twenty-six international experts comprised a multiprofessional panel to establish pediatrics-specific ventilator liberation clinical practice guidelines, focusing on acutely hospitalized children receiving invasive mechanical ventilation for more than 24 hours. Eleven key questions were identified and first prioritized using the Modified Convergence of Opinion on Recommendations and Evidence. A systematic review was conducted for questions that did not meet an a priori threshold of ⩾80% agreement, with Grading of Recommendations, Assessment, Development, and Evaluation methodologies applied to develop the guidelines. The panel evaluated the evidence and drafted and voted on the recommendations. Measurements and Main Results: Three questions related to systematic screening using an extubation readiness testing bundle and a spontaneous breathing trial as part of the bundle met Modified Convergence of Opinion on Recommendations criteria of ⩾80% agreement. For the remaining eight questions, five systematic reviews yielded 12 recommendations related to the methods and duration of spontaneous breathing trials, measures of respiratory muscle strength, assessment of risk of postextubation upper airway obstruction and its prevention, use of postextubation noninvasive respiratory support, and sedation. Most recommendations were conditional and based on low to very low certainty of evidence. Conclusions: This clinical practice guideline provides a conceptual framework with evidence-based recommendations for best practices related to pediatric ventilator liberation.Item Fluid Accumulation After Neonatal Congenital Cardiac Surgery; Clinical Implications and Outcomes(Elsevier, 2022) Bailly, David K.; Alten, Jeffrey A.; Gist, Katja M.; Mah, Kenneth E.; Kwiatkowski, David M.; Valentine, Kevin M.; Diddle, J. Wesley; Tadphale, Sachin; Clarke, Shanelle; Selewski, David T.; Banerjee, Mousumi; Reichle, Garrett; Lin, Paul; Gaies, Michael; Blinder, Joshua J.; Pediatrics, School of MedicineBACKGROUND To determine the association between fluid balance metrics and mortality and other postoperative outcomes after neonatal cardiac surgery in a contemporary multi-center cohort. METHODS Observational cohort study across 22 hospitals in neonates (≤30 days) undergoing cardiac surgery. We explored overall % fluid overload, postoperative day 1 % fluid overload, peak % fluid overload, and time to first negative daily fluid balance. The primary outcome was in-hospital mortality. Secondary outcomes included postoperative duration of mechanical ventilation, and intensive care unit (ICU) and hospital length of stay. Multivariable logistic or negative binomial regression was used to determine independent associations between fluid overload variables and each outcome. RESULTS The cohort included 2223 patients. In-hospital mortality was 3.9% (n=87). Overall median peak % fluid overload was 4.9%, (interquartile range 0.4-10.5%). Peak % fluid overload and postoperative day 1 % fluid overload were not associated with primary or secondary outcomes. Hospital resource utilization increased on each successive day of not achieving a first negative daily fluid balance and was characterized by longer duration of mechanical ventilation (incidence rate ratio 1.11, 95% confidence interval 1.08-1.14, ICU length of stay (incidence rate ratio 1.08, 95% confidence interval 1.03-1.12), and hospital length of stay (incidence rate ratio 1.09, 95% confidence interval 1.05-1.13). CONCLUSIONS Time to first negative daily fluid balance, but not % fluid overload is associated with improved postoperative outcomes in neonates after cardiac surgery. Specific treatments to achieve an early negative fluid balance may decrease postoperative care durations.Item Influence of Early Extubation Location on Outcomes Following Pediatric Cardiac Surgery(Wolters Kluwer, 2020-10) Rooney, Sydney R.; Mastropietro, Christopher M.; Benneyworth, Brian; Graham, Eric M.; Klugman, Darren; Costello, John; Ghanayem, Nancy; Zhang, Wenying; Banerjee, Mousumi; Gaies, Michael; Pediatrics, School of MedicineObjectives: Early extubation following pediatric cardiac surgery is common, but debate exists whether location affects outcome, with some centers performing routine early extubations in the operating room (odds ratio) and others in the cardiac ICU. We aimed to define early extubation practice variation across hospitals and assess impact of location on hospital length-of-stay and other outcomes. Design: Secondary analysis of the Pediatric Cardiac Critical Care Consortium registry. Setting: Twenty-eight Pediatric Cardiac Critical Care Consortium hospitals. Patients: Patients undergoing Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery mortality category 1-3 operations between August 2014 and February 2018. Interventions: None. Measurements and main results: We defined early extubation as extubation less than 6 hours after postoperative admission. Hospitals were categorized based on the proportion of their early extubation patients who underwent an odds ratio extubation. Categories included low- (< 50% of early extubation, n = 12), medium- (50%-90%, n = 8), or high- (> 90%, n = 8) frequency odds ratio early extubation centers. The primary outcome of interest was postoperative hospital length-of-stay. We analyzed 16,594 operations (9,143 early extubation, 55%). Rates of early extubation ranged from 16% to 100% across hospitals. Odds ratio early extubation rates varied from 16% to 99%. Patient characteristics were similar across hospital odds ratio early extubation categories. Early extubation rates paralleled the hospital odds ratio early extubation rates-77% patients underwent early extubation at high-frequency odds ratio extubation centers compared with 39% at low-frequency odds ratio extubation centers (p < 0.001). High- and low-frequency odds ratio early extubation hospitals had similar length-of-stay, cardiac arrest rates, and low mortality. However, high-frequency odds ratio early extubation hospitals used more noninvasive ventilation than low-frequency hospitals (15% vs. 9%; p < 0.01), but had fewer extubation failures (3.6% vs. 4.5%; p = 0.02). Conclusions: Considerable variability exists in early extubation practices after low- and moderate-complexity pediatric cardiac surgery. In this patient population, hospital length-of-stay did not differ significantly between centers with different early extubation strategies based on location or frequency.Item Operational Definitions related to Pediatric Ventilator Liberation(Elsevier, 2022-12-20) Abu-Sultaneh, Samer; Iyer, Narayan Prabhu; Fernández, Analía; Gaies, Michael; González-Dambrauskas, Sebastián; Hotz, Justin Christian; Kneyber, Martin C.J.; López-Fernández, Yolanda M.; Rotta, Alexandre T.; Werho, David K.; Baranwal, Arun Kumar; Blackwood, Bronagh; Craven, Hannah J.; Curley, Martha A.Q.; Essouri, Sandrine; Fioretto, Jose Roberto; Hartmann, Silvia M.M.; Jouvet, Philippe; Korang, Steven Kwasi; Rafferty, Gerrard F.; Ramnarayan, Padmanabhan; Rose, Louise; Tume, Lyvonne N.; Whipple, Elizabeth C.; Wong, Judith Ju Ming; Emeriaud, Guillaume; Mastropietro, Christopher W.; Napolitano, Natalie; Newth, Christopher J.L.; Khemani, Robinder G.BACKGROUND: Common, operational definitions are crucial to assess interventions and outcomes related to pediatric mechanical ventilation. These definitions can reduce unnecessary variability amongst research and quality improvement efforts, to ensure findings are generalizable and can be pooled to establish best practices. RESEARCH QUESTION: Can we establish operational definitions for key elements related to pediatric ventilator liberation using a combination of detailed literature review and consensus-based approaches? STUDY DESIGN AND METHODS: A panel of 26 international experts in pediatric ventilator liberation, two methodologists and two librarians conducted systematic reviews on eight topic areas related to pediatric ventilator liberation. Through a series of virtual meetings, we established draft definitions which were voted upon using an anonymous web-based process. Definitions were revised by incorporating extracted data gathered during the systematic review and discussed in another consensus meeting. A second round of voting was conducted to confirm the final definitions. RESULTS: In eight topic areas identified by the experts, 16 preliminary definitions were established. Based on initial discussion and the first round of voting, modifications were suggested for 11 of the 16 definitions. There was significant variability in how these items were defined in the literature reviewed. The final round of voting achieved ≥80% agreement for all 16 definitions in the following areas: what constitutes respiratory support (invasive mechanical ventilation and non-invasive respiratory support), liberation and failed attempts to liberate from invasive mechanical ventilation, liberation from respiratory support, duration of non-invasive respiratory support, total duration of invasive mechanical ventilation, spontaneous breathing trials, extubation readiness testing, 28-ventilator free days, and planned vs rescue use of post-extubation non-invasive respiratory support. INTERPRETATION: We propose these consensus-based definitions for elements of pediatric ventilator liberation, informed by evidence, be used for future quality improvement initiatives and research studies to improve generalizability, and facilitate comparison.Item Pediatric Organ Dysfunction Information Update Mandate (PODIUM) Contemporary Organ Dysfunction Criteria: Executive Summary(American Academy of Pediatrics, 2022) Bembea, Melania M.; Agus, Michael; Akcan-Arikan, Ayse; Alexander, Peta; Basu, Rajit; Bennett, Tellen D.; Bohn, Desmond; Brandão, Leonardo R.; Brown, Ann-Marie; Carcillo, Joseph A.; Checchia, Paul; Cholette, Jill; Cheifetz, Ira M.; Cornell, Timothy; Doctor, Allan; Eckerle, Michelle; Erickson, Simon; Farris, Reid W.D.; Faustino, E. Vincent S.; Fitzgerald, Julie C.; Fuhrman, Dana Y.; Giuliano, John S.; Guilliams, Kristin; Gaies, Michael; Gorga, Stephen M.; Hall, Mark; Hanson, Sheila J.; Hartman, Mary; Hassinger, Amanda B.; Irving, Sharon Y.; Jeffries, Howard; Jouvet, Philippe; Kannan, Sujatha; Karam, Oliver; Khemani, Robinder G.; Kissoon, Niranjan; Lacroix, Jacques; Laussen, Peter; Leclerc, Francis; Lee, Jan Hau; Leteurtre, Stephane; Lobner, Katie; McKiernan, Patrick J.; Menon, Kusum; Monagle, Paul; Muszynski, Jennifer A.; Odetola, Folafoluwa; Parker, Robert; Pathan, Nazima; Pierce, Richard W.; Pineda, Jose; Prince, Jose M.; Robinson, Karen A.; Rowan, Courtney M.; Ryerson, Lindsay M.; Sanchez-Pinto, L. Nelson; Schlapbach, Luregn J.; Selewski, David T.; Shekerdemian, Lara S.; Simon, Dennis; Smith, Lincoln S.; Squires, James E.; Squires, Robert H.; Sutherland, Scott M.; Ouellette, Yves; Spaeder, Michael C.; Srinivasan, Vijay; Steiner, Marie E.; Tasker, Robert C.; Thiagarajan, Ravi; Thomas, Neal; Tissieres, Pierre; Traube, Chani; Tucci, Marisa; Typpo, Katri V.; Wainwright, Mark S.; Ward, Shan L.; Watson, R. Scott; Weiss, Scott; Whitney, Jane; Willson, Doug; Wynn, James L.; Yehya, Nadir; Zimmerman, Jerry J.; Pediatrics, School of MedicinePrior criteria for organ dysfunction in critically ill children were based mainly on expert opinion. We convened the Pediatric Organ Dysfunction Information Update Mandate (PODIUM) expert panel to summarize data characterizing single and multiple organ dysfunction and to derive contemporary criteria for pediatric organ dysfunction. The panel was composed of 88 members representing 47 institutions and 7 countries. We conducted systematic reviews of the literature to derive evidence-based criteria for single organ dysfunction for neurologic, cardiovascular, respiratory, gastrointestinal, acute liver, renal, hematologic, coagulation, endocrine, endothelial, and immune system dysfunction. We searched PubMed and Embase from January 1992 to January 2020. Study identification was accomplished using a combination of medical subject headings terms and keywords related to concepts of pediatric organ dysfunction. Electronic searches were performed by medical librarians. Studies were eligible for inclusion if the authors reported original data collected in critically ill children; evaluated performance characteristics of scoring tools or clinical assessments for organ dysfunction; and assessed a patient-centered, clinically meaningful outcome. Data were abstracted from each included study into an electronic data extraction form. Risk of bias was assessed using the Quality in Prognosis Studies tool. Consensus was achieved for a final set of 43 criteria for pediatric organ dysfunction through iterative voting and discussion. Although the PODIUM criteria for organ dysfunction were limited by available evidence and will require validation, they provide a contemporary foundation for researchers to identify and study single and multiple organ dysfunction in critically ill children.Item Variation in extubation failure rates after neonatal congenital heart surgery across Pediatric Cardiac Critical Care Consortium hospitals(Elsevier, 2017-06) Benneyworth, Brian D.; Mastropietro, Christopher W.; Graham, Eric M.; Klugman, Darren; Costello, John M.; Zhang, Wenying; Gaies, Michael; Pediatrics, School of MedicineOBJECTIVE: In a multicenter cohort of neonates recovering from cardiac surgery, we sought to describe the epidemiology of extubation failure and its variability across centers, identify risk factors, and determine its impact on outcomes. METHODS: We analyzed prospectively collected clinical registry data on all neonates undergoing cardiac surgery in the Pediatric Cardiac Critical Care Consortium database from October 2013 to July 2015. Extubation failure was defined as reintubation less than 72 hours after the first planned extubation. Risk factors were identified using multivariable logistic regression with generalized estimating equations to account for within-center correlation. RESULTS: The cohort included 899 neonates from 14 Pediatric Cardiac Critical Care Consortium centers; 14% were premature, 20% had genetic abnormalities, 18% had major extracardiac anomalies, and 74% underwent surgery with cardiopulmonary bypass. Extubation failure occurred in 103 neonates (11%), within 24 hours in 61%. Unadjusted rates of extubation failure ranged from 5% to 22% across centers; this variability was unchanged after adjusting for procedural complexity and airway anomaly. After multivariable analysis, only airway anomaly was identified as an independent risk factor for extubation failure (odds ratio, 3.1; 95% confidence interval, 1.4-6.7; P = .01). Neonates who failed extubation had a greater median postoperative length of stay (33 vs 23 days, P < .001) and in-hospital mortality (8% vs 2%, P = .002). CONCLUSIONS: This multicenter study showed that 11% of neonates recovering from cardiac surgery fail initial postoperative extubation. Only congenital airway anomaly was independently associated with extubation failure. We observed a 4-fold variation in extubation failure rates across hospitals, suggesting a role for collaborative quality improvement to optimize outcomes.