Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Multicenter Study
. 2023 Mar;235(2):66-74.
doi: 10.1055/a-1976-9232. Epub 2023 Jan 19.

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

Catharina Nitsche  1   2 , Bettina Sarah Frauchiger  3 , Dominik Thiele  4   2 , Marc-Alexander Oestreich  3 , Berrit Liselotte Husstedt  1   2 , Ruth Margarethe Grychtol  5   6 , Nicole Maison  7   8   9 , Svenja Foth  10   11 , Meike Meyer  12 , Nikolas Jakobs  1   2 , Thomas Bahmer  13   14   2 , Gesine Hansen  5   6 , Erika von Mutius  7   8   9 , Matthias Kopp  3   1   2
Affiliations
Multicenter Study

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

Catharina Nitsche et al. Klin Padiatr. 2023 Mar.

Abstract
in English, German

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.

Hintergrund: Nitrogen Multiple Breath Washout (N2MBW) ist ein Lungenfunktionstest, der zur frühen Diagnostik von Erkrankungen der kleinen Atemwege eingesetzt wird. Qualitätskriterien werden aktuell nicht einheitlich angewendet und bisher wurden aus multizentrischen Studien nur wenige N2MBW Daten von Kindern mit asthmatischen Erkrankungen veröffentlicht.

Methoden: Kinder mit asthmatischen Erkrankungen sowie gesunde Kontrollpersonen wurden in die All Age Asthma Kohorte (ALLIANCE) eingeschlossen. Für die Messung der Ventilationsinhomogenität wurden N2MBW Tests von 2013 bis 2020 von fünf Zentren durchgeführt. In der retrospektiven zentralen Qualitätskontrolle wurde geprüft, ob die Messungen technisch verwertbar und wiederholbar waren. Mögliche Einflussfaktoren wie das Erfahrungsniveau wurden untersucht. Fehlerhaft kalibrierte Messsignale wurde nachträglich korrigiert.

Ergebnisse: N2MBW Tests von n=561 Teilnehmern wurden analysiert. Dies ergab n=949 (86.3%) gültige von insgesamt n=1390 Tests. Die Testakzeptanz in den Zentren reichte von 27.6% bis 77.8%. Vorzeitiges Beenden und Leckagen waren die häufigsten Ablehnungsgründe. Datenverlust führte zudem in einem Zentrum zur Ablehnung von 58% der Tests. Für Vorschulkinder ließ sich longitudinal eine steigende Qualität feststellen (χ2(8)=18,6; p=0,02).

Schlussfolgerung: N2MBW ist von Kindern mit asthmatischen Erkrankungen multizentrisch durchführbar. Die Qualität dieses zeitaufwändigen Verfahrens hängt von dem Erfahrungsstand des Personals bei Vorschulkindern ab und erfordert standardisierte Qualitätskontrolle.

PubMed Disclaimer

Conflict of interest statement

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.

Publication types