Quality Control of Nitrogen Multiple Breath Washout in a Multicenter Pediatric Asthma Study.

Autor: Nitsche C; University Children's Hospital, Division of Paediatric Pneumology and Allergology, University Medical Center Schleswig-Holstein Campus Luebeck, Luebeck, Germany.; Airway Research Center North (ARCN), Member of the German Center for Lung Research (DZL), Germany., Frauchiger BS; Department of Paediatrics, Division of Paediatric Respiratory Medicine and Allergology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland., Thiele D; Institute for Medical Biometry and Statistics, University of Luebeck, Luebeck, Germany.; Airway Research Center North (ARCN), Member of the German Center for Lung Research (DZL), Germany., Oestreich MA; Department of Paediatrics, Division of Paediatric Respiratory Medicine and Allergology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland., Husstedt BL; University Children's Hospital, Division of Paediatric Pneumology and Allergology, University Medical Center Schleswig-Holstein Campus Luebeck, Luebeck, Germany.; Airway Research Center North (ARCN), Member of the German Center for Lung Research (DZL), Germany., Grychtol RM; Department of Paediatric Pneumology, Allergology and Neonatology, Hannover Medical School, Hannover, Germany.; Biomedical Research in Endstage and Obstructive Lung Disease Hannover (BREATH); Member of the German Center for Lung Research (DZL), Germany., Maison N; Institute for Asthma- and Allergy Prevention (IAP), Helmholtz Zentrum Munich, German Research Center for Environmental Health (GmbH), Munich, Germany.; Dr von Hauner Children's Hospital, Ludwig Maximilians University Munich, Munich, Germany.; Comprehensive Pneumology Center - Munich (CPC-M); Member of the German Center for Lung Research (DZL), Germany., Foth S; University Children's Hospital Marburg, University of Marburg, Marburg, Germany.; Member of the German Center for Lung Research (DZL) , Universities of Giessen and Marburg Lung Center (UGMLC), Marburg, Germany., Meyer M; Department of Paediatrics, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany., Jakobs N; University Children's Hospital, Division of Paediatric Pneumology and Allergology, University Medical Center Schleswig-Holstein Campus Luebeck, Luebeck, Germany.; Airway Research Center North (ARCN), Member of the German Center for Lung Research (DZL), Germany., Bahmer T; Internal Medicine Department I, Pneumology, University Hospital Schleswig-Holstein Campus Kiel, Kiel, Germany.; LungenClinic Grosshansdorf GmbH, Grosshansdorf, Germany.; Airway Research Center North (ARCN), Member of the German Center for Lung Research (DZL), Germany., Hansen G; Department of Paediatric Pneumology, Allergology and Neonatology, Hannover Medical School, Hannover, Germany.; Biomedical Research in Endstage and Obstructive Lung Disease Hannover (BREATH); Member of the German Center for Lung Research (DZL), Germany., von Mutius E; Institute for Asthma- and Allergy Prevention (IAP), Helmholtz Zentrum Munich, German Research Center for Environmental Health (GmbH), Munich, Germany.; Dr von Hauner Children's Hospital, Ludwig Maximilians University Munich, Munich, Germany.; Comprehensive Pneumology Center - Munich (CPC-M); Member of the German Center for Lung Research (DZL), Germany., Kopp M; Department of Paediatrics, Division of Paediatric Respiratory Medicine and Allergology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.; University Children's Hospital, Division of Paediatric Pneumology and Allergology, University Medical Center Schleswig-Holstein Campus Luebeck, Luebeck, Germany.; Airway Research Center North (ARCN), Member of the German Center for Lung Research (DZL), Germany.
Jazyk: angličtina
Zdroj: Klinische Padiatrie [Klin Padiatr] 2023 Mar; Vol. 235 (2), pp. 66-74. Date of Electronic Publication: 2023 Jan 19.
DOI: 10.1055/a-1976-9232
Abstrakt: Background: Nitrogen multiple breath washout (N2MBW) is a lung function test increasingly used in small airway diseases. Quality criteria have not yet been globally implemented and time-consuming retrospective overreading is necessary. Little data has been published on children with recurrent wheeze or asthma from multicentered studies.
Methods: Children with wheeze or asthma and healthy controls were included in the longitudinal All Age Asthma Cohort (ALLIANCE). To assess ventilation inhomogeneity, N2MBW tests were performed in five centers from 2013 until 2020. All N2MBW tests were centrally overread by one center. Multiple washout procedures (trials) at the visit concluded to one test occasion. Tests were accepted if trials were technically sound (started correctly, terminated correctly, no leak, regular breathing pattern) and repeatable within one test occasion. Signal misalignment was retrospectively corrected. Factors that may impact test quality were analyzed, such as experience level.
Results: N2MBW tests of n=561 participants were analyzed leading to n=949 (68.3%) valid tests of n=1,390 in total. Inter-center test acceptability ranged from 27.6% to 77.8%. End-of-test criterion and leak were identified to be the most common reasons for rejection. Data loss and uncorrectable signal misalignment led to rejection of 58% of trials in one center. In preschool children, significant improvement of test acceptability was found longitudinally (χ2(8)=18.6; p=0.02).
Conclusion: N2MBW is feasible in a multicenter asthma study in children. However, the quality of this time-consuming procedure is dependent on experience level of staff in preschool children and still requires retrospective overreading for all age groups.
Competing Interests: TB reports grants from National Pandemic Cohort Network (NAPKON), funded by Network University Medicine (NUM)(BMBF grant number 01KX2021), during the conduct of the study; personal fees from AstraZeneca, personal fees from Novartis, personal fees from Pfizer, personal fees from GlaxoSmithKline, personal fees from BoeringerIngelheim, personal fees from Chiesi, personal fees from Merck, grants from German Center For Lung Research, outside the submitted work.EVM reports personal fees from Pharmaventures, personal fees from OM Pharma S. A., personal fees from Springer-Verlag GmbH, personal fees from Elsevier GmbH and Elsevier Ltd., personal fees from Peptinnovate Ltd., personal fees from Turun Yliopisto, personal fees from Tampereen Yliopisto, personal fees from Helsingin Yliopisto, personal fees from European Respiratory Society, personal fees from Deutsche Pharmazeutische Gesellschaft e. V., personal fees from Massachusetts Medical Society, personal fees from Chinese University of Hongkong, personal fees from European Commission, personal fees from Böhringer Ingelheim International GmbH, personal fees from Universiteit Utrecht, Faculteit Diergeneeskunde, personal fees from Universität Salzburg, personal fees from Georg Thieme Verlag, personal fees from Japanese Society of Pediatric Allergy and Clinical Immunology (JSPACI), Klinikum Rechts der Isar München, University of Colorado, Paul-Martini-Stiftung, Astra Zeneca, Imperial College London, Children´s Hospital Research Institute of Manitoba, Kompetenzzentrum für Ernährung (Kern), OM Pharma S.A., Swedish Pediatric Society for Allergy and Lung Medicine, Chinese College of Allergy and Asthma (CCAA), ALK-Abello Arzneimittel GmbH, Abbott Laboratories, Deutscher Apotheker Verlag GmbH & Co. KG, Chinese University of Hongkong, European Commission, HiPP GmbH & Co KG, OM Pharma S.A., Astra Zeneca MVK received consulting fees and/or payment or honoraria for lectures, presentations, speakers bureaus from Allergopharma GmbH, ALK-Abello, Chiesi GmbH, Infectopharm GmbH, Novartis Pharma GmbH, Sanofi Aventis GmbH, Vertex GmbH.The other authors have no conflict of interest to declare.
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Databáze: MEDLINE