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Journal ArticleDOI

International collaborative research for pediatric and neonatal lung injury: the example of an ESPNIC initiative to validate definitions and formulate future research questions

01 Mar 2014-Jornal De Pediatria (SOC BRASIL PEDIATRIA)-Vol. 90, Iss: 2, pp 209-211

TL;DR: The European Society for Pediatric and Neonatal Intensive Care (ESPNIC), together with some members of the original ARDS Task Force, have set up an international collaborative project to validate the new Berlin definition for infants and toddlers.

AbstractAn interesting review of acute respiratory distress (ARDS) definitions has been recently published in the Jornal de Pediatria, focusing on actual needs in terms of research and clinical care of pediatric ARDS. Unfortunately, timing prevented the consideration of an important step forward in this field. The European Society for Pediatric and Neonatal Intensive Care (ESPNIC), together with some members of the original ARDS Task Force, have set up an international collaborative project to validate the new Berlin definition for infants and toddlers. This project is the first initiative linking different pediatric intensive care units (PICU) in order to reach enough statistical power to address a specific research need. Figure 1 shows the ESPNIC net for this project. Indeed, as Fioretto et al. summarized, no specific pediatric validation had ever been conducted, even though some children were included in the original ARDS definition proposed by Ashbaugh et al. in 1967. Fioretto et al. described several possible limitations of the Berlin definition: however, some of the points raised by these authors should not be considered as a limitation, since the new Berlin definition is not supposed to be a predictive tool, but rather a framework to define a syndrome for epidemiology, clinical care, and research.

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Citations
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Journal ArticleDOI
TL;DR: The Berlin definition can identify a subgroup of patients with distinctly worse outcomes, as shown by the increased mortality and reduced number of ventilator-free days in pediatric patients with severe acute respiratory distress syndrome.
Abstract: Objectives:In 2012, a new acute respiratory distress syndrome definition was proposed for adult patients. It was later validated for infants and toddlers. Our objective was to evaluate the prevalence, outcomes, and risk factors associated with acute respiratory distress syndrome in children up to 15

28 citations


Journal ArticleDOI
TL;DR: Recommendations for the implementation of mechanical ventilation strategies in the treatment of acute respiratory distress syndrome in children and the use of adjuvant therapies are discussed.
Abstract: Acute respiratory distress syndrome is a disease of acute onset characterized by hypoxemia and infiltrates on chest radiographs that affects both adults and children of all ages. It is an important cause of respiratory failure in pediatric intensive care units and is associated with significant morbidity and mortality. Nevertheless, until recently, the definitions and diagnostic criteria for acute respiratory distress syndrome have focused on the adult population. In this article, we review the evolution of the definition of acute respiratory distress syndrome over nearly five decades, with a special focus on the new pediatric definition. We also discuss recommendations for the implementation of mechanical ventilation strategies in the treatment of acute respiratory distress syndrome in children and the use of adjuvant therapies.

18 citations


Cites background from "International collaborative researc..."

  • ...The Berlin definition does not include specific pediatric criteria but appears to have a good diagnostic performance in children younger than 24 months of age.(19) Children of all ages can be affected by and develop ARDS, including full-term newborns, but its prevalence increases with age; additionally, significant differences in prevalence are rarely observed between genders....

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01 Jan 2014
TL;DR: enrolled 221 children, medianage 6 months (range 2-13 months), which were categorized according to the two definitions, and the authors found veryinteresting and important results.
Abstract: enrolled 221 children, medianage 6 months (range 2-13 months), which were categorizedaccording to the two definitions. The authors found veryinteresting and important results. Applying AECC, 36 chil-dren were classified as ALI and 185 as ARDS, with mortalityrates of 13.9% and 17.8%, respectively. Conversely, 36 wereclassified as mild, 97 as moderate, and 88 as severe ARDS

Cites background from "International collaborative researc..."

  • ...Dear Sir, It was with great interest and pleasure that we read the Letter to the Editor entitled ‘‘International collaborative research for pediatric and neonatal lung injury: the example of an ESPNIC initiative to validate definitions and formulate future research questions’’ by Daniele De Luca et al.1 The authors commented that the European Society for Pediatric and Neonatal Intensive Care (ESPNIC) published the first validation of the acute respiratory distress syndrome (ARDS) Berlin Definition (BD) in early childhood.2 Members of the ESPNIC Respiratory Section performed a retrospective international (Italy, Spain, France, Austria, and the Netherlands) multicenter study including children aged between 30 days and 18 months with ARDS according to the American-European Consensus Conference (AECC) criteria.3 It elegantly addresses our concerns on the applicability of BD in pediatrics when we described the evolution of ARDS definitions.4 A time lapse between the two publications prevented exact connections between them; now is the opportunity to do so....

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  • ...In summary, we congratulate De Luca et al.2 for their timely study, and thank them for their comments....

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  • ...It was with great interest and pleasure that we read the Letter to the Editor entitled ‘‘International collaborative research for pediatric and neonatal lung injury: the example of an ESPNIC initiative to validate definitions and formulate future research questions’’ by Daniele De Luca et al.(1) The authors commented that the European Society for Pediatric and Neonatal Intensive Care (ESPNIC) published the first validation of the acute respiratory distress syndrome (ARDS) Berlin Definition (BD) in early childhood....

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References
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Journal ArticleDOI
20 Jun 2012-JAMA
TL;DR: The updated and revised Berlin Definition for ARDS addresses a number of the limitations of the AECC definition and may serve as a model to create more accurate, evidence-based, critical illness syndrome definitions and to better inform clinical care, research, and health services planning.
Abstract: The acute respiratory distress syndrome (ARDS) was defined in 1994 by the American-European Consensus Conference (AECC); since then, issues regarding the reliability and validity of this definition have emerged. Using a consensus process, a panel of experts convened in 2011 (an initiative of the European Society of Intensive Care Medicine endorsed by the American Thoracic Society and the Society of Critical Care Medicine) developed the Berlin Definition, focusing on feasibility, reliability, validity, and objective evaluation of its performance. A draft definition proposed 3 mutually exclusive categories of ARDS based on degree of hypoxemia: mild (200 mm Hg < PaO2/FIO2 ≤ 300 mm Hg), moderate (100 mm Hg < PaO2/FIO2 ≤ 200 mm Hg), and severe (PaO2/FIO2 ≤ 100 mm Hg) and 4 ancillary variables for severe ARDS: radiographic severity, respiratory system compliance (≤40 mL/cm H2O), positive end-expiratory pressure (≥10 cm H2O), and corrected expired volume per minute (≥10 L/min). The draft Berlin Definition was empirically evaluated using patient-level meta-analysis of 4188 patients with ARDS from 4 multicenter clinical data sets and 269 patients with ARDS from 3 single-center data sets containing physiologic information. The 4 ancillary variables did not contribute to the predictive validity of severe ARDS for mortality and were removed from the definition. Using the Berlin Definition, stages of mild, moderate, and severe ARDS were associated with increased mortality (27%; 95% CI, 24%-30%; 32%; 95% CI, 29%-34%; and 45%; 95% CI, 42%-48%, respectively; P < .001) and increased median duration of mechanical ventilation in survivors (5 days; interquartile [IQR], 2-11; 7 days; IQR, 4-14; and 9 days; IQR, 5-17, respectively; P < .001). Compared with the AECC definition, the final Berlin Definition had better predictive validity for mortality, with an area under the receiver operating curve of 0.577 (95% CI, 0.561-0.593) vs 0.536 (95% CI, 0.520-0.553; P < .001). This updated and revised Berlin Definition for ARDS addresses a number of the limitations of the AECC definition. The approach of combining consensus discussions with empirical evaluation may serve as a model to create more accurate, evidence-based, critical illness syndrome definitions and to better inform clinical care, research, and health services planning.

6,097 citations


Journal ArticleDOI
TL;DR: Positive end-expiratory pressure was most helpful in combating atelectasis and hypoxaemia and Corticosteroids appeared to have value in the treatment of patients with fat-embolism and possibly viral pneumonia.
Abstract: The respiratory-distress syndrome in 12 patients was manifested by acute onset of tachypnœa, hypoxaemia, and loss of compliance after a variety of stimuli; the syndrome did not respond to usual and ordinary methods of respiratory therapy. The clinical and pathological features closely resembled those seen in infants with respiratory distress and to conditions in congestive atelectasis and postperfusion lung. The theoretical relationship of this syndrome to alveolar surface active agent is postulated. Positive end-expiratory pressure was most helpful in combating atelectasis and hypoxaemia. Corticosteroids appeared to have value in the treatment of patients with fat-embolism and possibly viral pneumonia.

3,479 citations


"International collaborative researc..." refers methods in this paper

  • ...The Brazilian Pediatric ARDS Study Group6 performed a prospective, multicentre cohort study from March to September of 2013, which aimed: (1) to evaluate the prevalence of ARDS; (2) to determine risk factors for ARDS; and (3) to evaluate whether the use of BD in critically ill children can better discriminate the severity of the disease compared with the AECC definition....

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Journal ArticleDOI
TL;DR: This panel addressed some of the limitations of the prior ARDS definition by incorporating current data, physiologic concepts, and clinical trials results to develop the Berlin definition, which should facilitate case recognition and better match treatment options to severity in both research trials and clinical practice.
Abstract: Our objective was to revise the definition of acute respiratory distress syndrome (ARDS) using a conceptual model incorporating reliability and validity, and a novel iterative approach with formal evaluation of the definition. The European Society of Intensive Care Medicine identified three chairs with broad expertise in ARDS who selected the participants and created the agenda. After 2 days of consensus discussions a draft definition was developed, which then underwent empiric evaluation followed by consensus revision. The Berlin Definition of ARDS maintains a link to prior definitions with diagnostic criteria of timing, chest imaging, origin of edema, and hypoxemia. Patients may have ARDS if the onset is within 1 week of a known clinical insult or new/worsening respiratory symptoms. For the bilateral opacities on chest radiograph criterion, a reference set of chest radiographs has been developed to enhance inter-observer reliability. The pulmonary artery wedge pressure criterion for hydrostatic edema was removed, and illustrative vignettes were created to guide judgments about the primary cause of respiratory failure. If no risk factor for ARDS is apparent, however, objective evaluation (e.g., echocardiography) is required to help rule out hydrostatic edema. A minimum level of positive end-expiratory pressure and mutually exclusive PaO2/FiO2 thresholds were chosen for the different levels of ARDS severity (mild, moderate, severe) to better categorize patients with different outcomes and potential responses to therapy. This panel addressed some of the limitations of the prior ARDS definition by incorporating current data, physiologic concepts, and clinical trials results to develop the Berlin definition, which should facilitate case recognition and better match treatment options to severity in both research trials and clinical practice.

870 citations


"International collaborative researc..." refers background in this paper

  • ...In addition, concerns were expressed regarding the application of the new Berlin criteria to the pediatric population, as there were no children in their original development population.(4,5) This is the reason why the Respiratory Failure Section of ESPNIC started the above-mentioned project to evaluate the reliability of the new Berlin definition in a homogeneous and adequately large pediatric population....

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Journal ArticleDOI
TL;DR: An observer agreement study in which two of eight intensivists and a radiologist, blinded to one another's interpretation, reviewed 778 radiographs from 99 critically ill patients concludes that intensivist without formal consensus training can achieve moderate levels of agreement.
Abstract: To measure the reliability of chest radiographic diagnosis of acute respiratory distress syndrome (ARDS) we conducted an observer agreement study in which two of eight intensivists and a radiologist, blinded to one another's interpretation, reviewed 778 radiographs from 99 critically ill patients. One intensivist and a radiologist participated in pilot training. Raters made a global rating of the presence of ARDS on the basis of diffuse bilateral infiltrates. We assessed interobserver agreement in a pairwise fashion. For rater pairings in which one rater had not participated in the consensus process we found moderate levels of raw (0.68 to 0.80), chance-corrected ( κ 0.38 to 0.55), and chance-independent ( Φ 0.53 to 0.75) agreement. The pair of raters who participated in consensus training achieved excellent to almost perfect raw (0.88 to 0.94), chance-corrected ( κ 0.72 to 0.88), and chance-independent ( Φ 0.74 to 0.89) agreement. We conclude that intensivists without formal consensus training can achiev...

248 citations


"International collaborative researc..." refers methods in this paper

  • ...Both are practical tools that have proven to be helpful in clinical practice and research.(2,4,7,8) However, the ESPNIC collaborative work validating the new Berlin criteria for pediatric ARDS patients has some limitations that have already been pointed out....

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Journal ArticleDOI
TL;DR: Evidence supports dropping the hemoglobin transfusion threshold to 7 g/dL once profound hypoxia and shock have resolved, and promising therapies for pediatric ALI/ARDS based on pediatric studies include endotracheal surfactant, high-frequency oscillatory ventilation, noninvasive ventilation, and use of extracorporeal membrane oxygenation as a rescue therapy.
Abstract: Background:Acute lung injury (ALI) and its more severe form, acute respiratory distress syndrome (ARDS), are devastating disorders of overwhelming pulmonary inflammation and hypoxemia, resulting in high morbidity and mortality.Aim:To provide the clinician with a summary of the literature on the epid

191 citations


"International collaborative researc..." refers background in this paper

  • ...In fact, infants and toddlers present peculiarities regarding lung development, respiratory system mechanics, and co-morbidities, which are responsible for the peculiar epidemiology and prognosis of ARDS in these patients.(6) The main results demonstrated that the new Berlin definition has the same reliability both for the pediatric and adult patients in terms of mortality and need for extracorporeal life support....

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  • ...The project focused on the early pediatric age (range: 30 days to 18 months), since especially at this age, the syndrome is distinctly different from ARDS in adults.(2,6) In fact, infants and toddlers present peculiarities regarding lung development, respiratory system mechanics, and co-morbidities, which are responsible for the peculiar epidemiology and prognosis of ARDS in these patients....

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