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2. Parents' prioritised outcomes for trials investigating treatments for paediatric severe infection: a qualitative synthesis.

Author

Woolfall K, O'Hara C, Deja E, Canter R, Khan I, Mouncey P, Carter A, Jones N, Watkins J, Lyttle MD, Tume L, Agbeko R, Tibby SM, Pappachan J, Thorburn K, Rowan KM, Peters MJ, and Inwald D

Subjects
Bacterial Infections mortality, Child, Child, Preschool, Emotions, Feasibility Studies, Female, Humans, Male, Professional-Family Relations, Qualitative Research, Stress, Psychological, Virus Diseases mortality, Bacterial Infections therapy, Critical Care psychology, Intensive Care Units, Pediatric, Outcome Assessment, Health Care methods, Parents psychology, Virus Diseases therapy
Abstract

Objective: To identify parents' prioritised outcomes by combining qualitative findings from two trial feasibility studies of interventions for paediatric suspected severe infection., Design: Qualitative synthesis combining parent interview data from the Fluids in Shock (FiSh) and Fever feasibility studies. Parents had experience of their child being admitted to a UK emergency department or intensive care unit with a suspected infection., Participants: n=: 85 parents. FiSh study: n=41 parents, 37 mothers, 4 fathers, 7 were bereaved. Fever study: n=44 parents, 33 mothers, 11 fathers, 7 were bereaved., Results: In addition to survival, parents prioritised short-term outcomes including: organ and physiological functioning (eg, heart rate, breathing rate and temperature); their child looking and/or behaving more like their normal self; and length of time on treatments or mechanical support. Longer term prioritised outcomes included effects of illness on child health and development. We found that parents' prioritisation of outcomes was influenced by their experience of their child's illness, survival and the point at which they are asked about outcomes of importance in the course of their child's illness., Conclusions: Findings provide insight into parent prioritised outcomes to inform the design of future trials investigating treatments for paediatric suspected or proven severe infection as well as core outcome set development work., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.)

Published
2019
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3. Conservative versus liberal oxygenation targets in critically ill children: the randomised multiple-centre pilot Oxy-PICU trial.

Author

Peters MJ, Jones GAL, Wiley D, Wulff J, Ramnarayan P, Ray S, Inwald D, Grocott M, Griksaitis M, Pappachan J, O'Neill L, Eaton S, Mouncey PR, Harrison DA, and Rowan KM

Subjects
Adolescent, Child, Child, Preschool, Critical Illness, Hospitalization, Humans, Infant, Infant, Newborn, Intensive Care Units, Pediatric, Oximetry, Critical Care, Oxygen blood, Oxygen Inhalation Therapy
Abstract

Background: Oxygen saturation monitoring for children receiving respiratory support is standard worldwide. No randomised clinical trials have compared peripheral oxygen saturation (SpO 2 ) targets for critically ill children. The harm of interventions to raise SpO 2 to > 94% may exceed their benefits., Methods: We undertook an open, parallel-group randomised trial of children > 38 weeks completed gestation and < 16 years of age receiving invasive or non-invasive respiratory support and supplemental oxygen who were admitted urgently to one of three paediatric intensive care units. A 'research without prior consent' approach was employed. Children were randomly assigned to a liberal oxygenation group (SpO 2 targets > 94%) or a conservative oxygenation group (SpO 2  = 88-92% inclusive). Outcomes were measures of feasibility: recruitment rate, protocol adherence and acceptability, between-group separation of SpO 2 and safety. The Oxy-PICU trial was registered before recruitment: ClinicalTrials.gov identifier NCT03040570., Results: A total of 159 children met the inclusion criteria, of whom 119 (75%) were randomised between April and July 2017, representing a rate of 10 patients per month per site. The mean time to randomisation from first contact with an intensive care team was 1.9 (SD 2.2) h. Consent to continue in the study was obtained in 107 cases (90%); the children's parents/legal representatives were supportive of the consent process. The median (interquartile range, IQR) of time-weighted individual mean SpO 2 was 94.9% (92.6-97.1) in the conservative oxygenation group and 97.5% (96.2-98.4) in the liberal group [difference 2.7%, 95% confidence interval (95% CI) 1.3-4.0%, p < 0.001]. Median (IQR) time-weighted individual mean FiO 2 was 0.28 (0.24-0.37) in the conservative group and 0.37 (0.30-0.42) in the liberal group (difference 0.08, 95% CI 0.03-0.13, p < 0.001). There were no significant between-group differences in length of stay, duration of organ support or mortality. Two prespecified serious adverse events (cardiac arrests) occurred, both in the liberal oxygenation group., Conclusion: A definitive clinical trial of peripheral oxygen saturation targets is feasible in critically ill children.

Published
2018
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4. The effects of two methods for customising the original SAPS II model for intensive care patients from South England.

Author

Beck DH, Smith GB, and Pappachan JV

Subjects
Adolescent, Adult, Aged, Aged, 80 and over, England epidemiology, Female, Hospital Mortality, Humans, Logistic Models, Male, Middle Aged, Prognosis, Reproducibility of Results, Critical Care, Critical Illness mortality, Health Status Indicators
Abstract

Model customisation is used to adjust prognostic models by re-calibrating them to obtain more reliable mortality estimates. We used two methods for customising the Simplified Acute Physiology Score II model for 15,511 intensive care patients by altering the logit and the coefficients of the original equation. Both methods significantly improved model calibration, but customising the coefficients was slightly more effective. The Hosmer-Lemeshow chi(2)-value improved from 306.0 (p< 0.001) before, to 14.5 (p < 0.07) and 23.3 (p < 0.06) after customisation of the coefficients and the logit, respectively. Discrimination was not affected. The standardised mortality ratio for the entire population declined from 1.16 (95% confidence interval: 1.13-1.20, p < 0.001) to 0.99 (95% confidence interval: 0.96-1.02, p < 0.22) after customisation of the coefficients. The uniformity-of-fit for patients grouped by operative status and comorbidities also improved, but remained imperfect for patients stratified by location before intensive care unit admission. Amalgamation of large, regional databases could provide the basis for the re-calibration of standard prognostic models, which could then be used as a national reference system to allow more reliable comparisons of the efficacy and quality of care based on severity adjusted outcome measures.

Published
2002
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5. Analysis of intensive care populations to select possible candidates for high dependency care.

Author

Pappachan JV, Millar BW, Barrett DJ, and Smith GB

Subjects
APACHE, Adult, Aged, Aged, 80 and over, Female, Hospital Mortality, Humans, Male, Middle Aged, Patient Selection, United Kingdom, Critical Care classification, Risk Assessment
Abstract

Objectives: To identify the proportion, and range across intensive care units, of intensive care patients who might potentially be managed on a high dependency unit (HDU) using three different classification systems., Methods: 8095 adult patients admitted to 15 intensive care units in the south of England between 1 April 1993 and 31 December 1994 were studied. Patients were identified as potential HDU admissions if their APACHE III derived risk of hospital mortality was < or =10%, if they were categorised as a low risk monitor (LRM) patient using the Wagner risk stratification method, or if they did not require advanced respiratory support (ARS)., Results: 4146 patients (51.2%) had an APACHE III derived risk of hospital death of < or =10%, 1687 (20.8%) were classified as LRM, and 3860 (47.7%) did not receive ARS. The values for each intensive care unit ranged from 32.8-63.3% (APACHE III group), 7.2-29.9% (LRM group), and 14.4-68.2% (ARS group). No matter which of the three methods was used, there were significant differences between the 15 units (p<0.0001) with regard to the number of potential HDU patients identified within the scored population., Conclusions: The percentage of intensive care patients who might be more appropriately managed in a HDU varies considerably between hospitals, and depends upon both local circumstances and the method used to define a high dependency patient. However, whichever method is used, it appears that significant numbers of patients of low dependency status currently fill intensive care beds in the units studied. If these analyses are correct, the perceived national shortage in intensive care beds might be improved by the development of HDUs.

Published
1999
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6. Mechanical power in pediatric acute respiratory distress syndrome: a PARDIE study

Author

Bhalla AK, Klein MJ, Modesto I Alapont V, Emeriaud G, Kneyber MCJ, Medina A, Cruces P, Diaz F, Takeuchi M, Maddux AB, Mourani PM, Camilo C, White BR, Yehya N, Pappachan J, Di Nardo M, Shein S, Newth C, Khemani R, and Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network

Subjects
Mechanical, Pediatrics, Ventilator-induced lung injury, Ventilators, Critical care
Abstract

BACKGROUND: Mechanical power is a composite variable for energy transmitted to the respiratory system over time that may better capture risk for ventilator-induced lung injury than individual ventilator management components. We sought to evaluate if mechanical ventilation management with a high mechanical power is associated with fewer ventilator-free days (VFD) in children with pediatric acute respiratory distress syndrome (PARDS). METHODS: Retrospective analysis of a prospective observational international cohort study. RESULTS: There were 306 children from 55 pediatric intensive care units included. High mechanical power was associated with younger age, higher oxygenation index, a comorbid condition of bronchopulmonary dysplasia, higher tidal volume, higher delta pressure (peak inspiratory pressure-positive end-expiratory pressure), and higher respiratory rate. Higher mechanical power was associated with fewer 28-day VFD after controlling for confounding variables (per 0.1 J·min(-1)·Kg(-1) Subdistribution Hazard Ratio (SHR) 0.93 (0.87, 0.98), p = 0.013). Higher mechanical power was not associated with higher intensive care unit mortality in multivariable analysis in the entire cohort (per 0.1 J·min(-1)·Kg(-1) OR 1.12 [0.94, 1.32], p = 0.20). But was associated with higher mortality when excluding children who died due to neurologic reasons (per 0.1 J·min(-1)·Kg(-1) OR 1.22 [1.01, 1.46], p = 0.036). In subgroup analyses by age, the association between higher mechanical power and fewer 28-day VFD remained only in children < 2-years-old (per 0.1 J·min(-1)·Kg(-1) SHR 0.89 (0.82, 0.96), p = 0.005). Younger children were managed with lower tidal volume, higher delta pressure, higher respiratory rate, lower positive end-expiratory pressure, and higher PCO(2) than older children. No individual ventilator management component mediated the effect of mechanical power on 28-day VFD. CONCLUSIONS: Higher mechanical power is associated with fewer 28-day VFDs in children with PARDS. This association is strongest in children < 2-years-old in whom there are notable differences in mechanical ventilation management. While further validation is needed, these data highlight that ventilator management is associated with outcome in children with PARDS, and there may be subgroups of children with higher potential benefit from strategies to improve lung-protective ventilation. TAKE HOME MESSAGE: Higher mechanical power is associated with fewer 28-day ventilator-free days in children with pediatric acute respiratory distress syndrome. This association is strongest in children

Published
2022

7. Non-invasive respiratory support for infants with bronchiolitis: a national survey of practice

Author

Turnham, H., Agbeko, R. S., Furness, J., Pappachan, J., Sutcliffe, A. G., and Ramnarayan, P.

Subjects
Male, Wales, Continuous Positive Airway Pressure, Infant, Newborn, Oxygen Inhalation Therapy, Infant, Respiratory failure, Critical care, Cross-Sectional Studies, England, Health Care Surveys, Bronchiolitis, Humans, Female, Pediatrics, Perinatology, and Child Health, Practice Patterns, Physicians', Non-invasive respiratory support, Research Article
Abstract

Background Bronchiolitis is a common respiratory illness of early childhood. For most children it is a mild self-limiting disease but a small number of children develop respiratory failure. Nasal continuous positive airway pressure (nCPAP) has traditionally been used to provide non-invasive respiratory support in these children, but there is little clinical trial evidence to support its use. More recently, high-flow nasal cannula therapy (HFNC) has emerged as a novel respiratory support modality. Our study aims to describe current national practice and clinician preferences relating to use of non-invasive respiratory support (nCPAP and HFNC) in the management of infants (

Published
2017

8. Comparison of Pediatric Severe Sepsis Managed in U.S. and European ICUs

Author

Giuliano, John S, Markovitz, Barry P., Brierley, Joe, Levin, Richard, Williams, Gary, Lum, Lucy Chai See, Dorofaeff, Tavey, Cruces, Pablo, Bush, Jenny L., Keele, Luke, Nadkarni, Vinay M., Thomas, Neal J., Fitzgerald, Julie C., Weiss, Scott L., Fontela, P., Tucci, M., Dumistrascu, M., Skippen, P., Krahn, G., Bezares, E., Puig, G., Puig Ramos, A., Garcia, R., Villar, M., Bigham, M., Polanski, T., Latifi, S., Giebner, D., Anthony, H., Hume, J., Galster, A., Linnerud, L., Sanders, R., Hefley, G., Madden, K., Thompson, A., Shein, S., Gertz, S., Han, Y., Williams, T., Hughes Schalk, A., Chandler, H., Orioles, A., Zielinski, E., Doucette, A., Zebuhr, C., Wilson, T., Dimitriades, C., Ascani, J., Layburn, S., Valley, S., Markowitz, B., Terry, J., Morzov, R., Mcinnes, A., Mcarthur, J., Woods, K., Murkowski, K., Spaeder, M., Sharron, M., Wheeler, D., Beckman, E., Frank, E., Howard, K., Carroll, C., Nett, S., Jarvis, D., Patel, V., Higgerson, R., Christie, L., Typpo, K., Deschenes, J., Kirby, A., Uhl, T., Rehder, K., Cheifetz, I., Wrenn, S., Kypuros, K., Ackerman, K., Maffei, F., Bloomquist, G., Rizkalla, N., Kimura, D., Shah, S., Tigges, C., Su, F., Barlow, C., Michelson, K., Wolfe, K., Goodman, D., Campbell, L., Sorce, L., Bysani, K., Monjure, T., Evans, M., Totapally, B., Chegondi, M., Rodriguez, C., Frazier, J., Steele, L., Viteri, S., Costarino, A., Thomas, N., Spear, D., Hirshberg, E., Lilley, J., Rowan, C., Rider, C., Kane, J., Zimmerman, J., Greeley, C., Lin, J., Jacobs, R., Parker, M., Culver, K., Loftis, L., Jaimon, N., Goldsworthy, M., Fitzgerald, J., Weiss, S., Nadkarni, V., Bush, J., Diliberto, M., Alen, C., Gessouroun, M., Sapru, A., Lang, T., Alkhouli, M., Kamath, S., Friel, D., Daufeldt, J., Hsing, D., Carlo, C., Pon, S., Scimeme, J., Shaheen, A., Hassinger, A., Qiao, H., Giuliano, J., Tala, J., Vinciguerra, D., Fernandez, A., Carrero, R., Hoyos, P., Jaramillo, J., Posada, A., Izquiierdo, L., Piñeres Olave, B. E., Donado, J., Dalmazzo, R., Rendich, S., Palma, L., Lapadula, M., Acuna, C., Cruces, P., Clement De Clety, S., Dujardin, M., Berghe, C., Renard, S., Zurek, J., Steinherr, H., Mougkou, K., Critselis, E., Di Nardo, M., Picardo, S., Tortora, F., Rossetti, E., Fragasso, T., Cogo, Paola, Netto, R., Dagys, A., Gurskis, V., Kevalas, R., Neeleman, C., Lemson, J., Luijten, C., Wojciech, K., Pagowska Klimek, I., Szczepanska, M., Karpe, J., Nunes, P., Almeida, H., Rios, J., Vieira, M., Revilla, P., Urbano, J., Lopez Herce, J., Bustinza, A., Cuesta, A., Hofheinz, S., Rodriguez Nunez, A., Sanagustin, S., Gonzalez, E., Riaza, M., Piaya, R., Soler, P., Esteban, E., Laraudogoitia, J., Monge, C., Herrera, V., Granados, J., Gonzalez, C., Koroglu, T., Ozcelik, E., Baines, P., Plunkett, A., Davis, P., George, S., Tibby, S., Harris, J., Agbeko, R., Lampitt, R., Brierley, J., Peters, M., Jones, A., Dominguez, T., Thiruchelvam, T., Deep, A., Ridley, L., Bowen, W., Levin, R., Macleod, I., Gray, M., Hemat, N., Alexander, J., Ali, S., Pappachan, J., Mccorkell, J., Fortune, P., Macdonald, M., Hudnott, P., Suyun, Q., Singhi, S., Nallasamy, K., Lodha, R., Shime, N., Tabata, Y., Saito, O., Ikeyama, T., Kawasaki, T., Lum, L., Abidin, A., Kee, S., Tang, S., Jalil, R., Guan, Y., Yao, L., Lin, K., Ong, J., Salloo, A., Doedens, L., Mathivha, L., Reubenson, G., Moaisi, S., Pentz, A., Green, R., Schibler, A., Erickson, S., Mceneiry, J., Long, D., Dorofaeff, T., Coulthard, M., Millar, J., Delzoppo, C., Williams, G., Morritt, M., Watts, N., Beca, J., Sherring, C., and Bushell, T.

Subjects
Male, Pediatrics, Cross-sectional study, shock, Critical Care and Intensive Care Medicine, Severity of Illness Index, 0302 clinical medicine, Prevalence, Hospital Mortality, Prospective Studies, 030212 general & internal medicine, Practice Patterns, Physicians', Child, Prospective cohort study, Pediatric intensive care unit, Perinatology and Child Health, Europe, Treatment Outcome, Child, Preschool, outcome, children, management, pediatric intensive care unit, Pediatrics, Perinatology and Child Health, Female, medicine.symptom, medicine.medical_specialty, Adolescent, Critical Care, Intensive Care Units, Pediatric, Sepsis, 03 medical and health sciences, Intensive care, Severity of illness, medicine, Humans, Healthcare Disparities, business.industry, Organ dysfunction, Infant, Newborn, Infant, 030208 emergency & critical care medicine, Health Status Disparities, medicine.disease, United States, Clinical trial, Cross-Sectional Studies, Multivariate Analysis, Emergency medicine, business
Abstract

Copyright © 2016 by the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies.Objectives: Pediatric severe sepsis remains a significant global health problem without new therapies despite many multicenter clinical trials. We compared children managed with severe sepsis in European and U.S. PICUs to identify geographic variation, which may improve the design of future international studies. Design: We conducted a secondary analysis of the Sepsis PRevalence, OUtcomes, and Therapies study. Data about PICU characteristics, patient demographics, therapies, and outcomes were compared. Multivariable regression models were used to determine adjusted differences in morbidity and mortality. Setting: European and U.S. PICUs. Patients: Children with severe sepsis managed in European and U.S. PICUs enrolled in the Sepsis PRevalence, OUtcomes, and Therapies study. Interventions: None. Measurements and Main Results: European PICUs had fewer beds (median, 11 vs 24; p < 0.001). European patients were younger (median, 1 vs 6 yr; p < 0.001), had higher severity of illness (median Pediatric Index of Mortality-3, 5.0 vs 3.8; p = 0.02), and were more often admitted from the ward (37% vs 24%). Invasive mechanical ventilation, central venous access, and vasoactive infusions were used more frequently in European patients (85% vs 68%, p = 0.002; 91% vs 82%, p = 0.05; and 71% vs 50%; p < 0.001, respectively). Raw morbidity and mortality outcomes were worse for European compared with U.S. patients, but after adjusting for patient characteristics, there were no significant differences in mortality, multiple organ dysfunction, disability at discharge, length of stay, or ventilator/vasoactive-free days. Conclusions: Children with severe sepsis admitted to European PICUs have higher severity of illness, are more likely to be admitted from hospital wards, and receive more intensive care therapies than in the United States. The lack of significant differences in morbidity and mortality after adjusting for patient characteristics suggests that the approach to care between regions, perhaps related to PICU bed availability, needs to be considered in the design of future international clinical trials in pediatric severe sepsis.

Published
2016

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