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

Catharina Nitsche; Bettina Sarah Frauchiger; Dominik Thiele; Marc-Alexander Oestreich; Berrit Liselotte Husstedt; Ruth Margarethe Grychtol; Nicole Maison; Svenja Foth; Meike Meyer; Nikolas Jakobs; Thomas Bahmer; Gesine Hansen; Erika von Mutius; Matthias Kopp

doi:10.1055/a-1976-9232

Klinische Pädiatrie, Inhaltsverzeichnis

Klin Padiatr 2023; 235(02): 66-74
DOI: 10.1055/a-1976-9232

Original Article

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

Qualitätskontrolle von Gasauswaschverfahren bei Kindern mit asthmatischen Erkrankungen in einer multizentrischen Studie

Catharina Nitsche

¹University Children’s Hospital, Division of Paediatric Pneumology and Allergology, University Medical Center Schleswig-Holstein Campus Luebeck, Luebeck, Germany

²Airway Research Center North (ARCN), Member of the German Center for Lung Research (DZL), Germany

,

Bettina Sarah Frauchiger

³Department of Paediatrics, Division of Paediatric Respiratory Medicine and Allergology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland

,

Dominik Thiele

⁴Institute for Medical Biometry and Statistics, University of Luebeck, Luebeck, Germany

²Airway Research Center North (ARCN), Member of the German Center for Lung Research (DZL), Germany

,

Marc-Alexander Oestreich

³Department of Paediatrics, Division of Paediatric Respiratory Medicine and Allergology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland

,

Berrit Liselotte Husstedt

¹University Children’s Hospital, Division of Paediatric Pneumology and Allergology, University Medical Center Schleswig-Holstein Campus Luebeck, Luebeck, Germany

²Airway Research Center North (ARCN), Member of the German Center for Lung Research (DZL), Germany

,

Ruth Margarethe Grychtol

⁵Department of Paediatric Pneumology, Allergology and Neonatology, Hannover Medical School, Hannover, Germany

⁶Biomedical Research in Endstage and Obstructive Lung Disease Hannover (BREATH); Member of the German Center for Lung Research (DZL), Germany

,

Nicole Maison

⁷Institute for Asthma- and Allergy Prevention (IAP), Helmholtz Zentrum Munich, German Research Center for Environmental Health (GmbH), Munich, Germany

⁸Dr von Hauner Children’s Hospital, Ludwig Maximilians University Munich, Munich, Germany

⁹Comprehensive Pneumology Center – Munich (CPC-M); Member of the German Center for Lung Research (DZL), Germany

,

Svenja Foth

¹⁰University Children’s Hospital Marburg, University of Marburg, Marburg, Germany

¹¹Member of the German Center for Lung Research (DZL) , Universities of Giessen and Marburg Lung Center (UGMLC), Marburg, Germany

,

Meike Meyer

¹²Department of Paediatrics, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany

,

Nikolas Jakobs

¹University Children’s Hospital, Division of Paediatric Pneumology and Allergology, University Medical Center Schleswig-Holstein Campus Luebeck, Luebeck, Germany

²Airway Research Center North (ARCN), Member of the German Center for Lung Research (DZL), Germany

,

Thomas Bahmer

¹³Internal Medicine Department I, Pneumology, University Hospital Schleswig-Holstein Campus Kiel, Kiel, Germany

¹⁴LungenClinic Grosshansdorf GmbH, Grosshansdorf, Germany

²Airway Research Center North (ARCN), Member of the German Center for Lung Research (DZL), Germany

,

Gesine Hansen

⁵Department of Paediatric Pneumology, Allergology and Neonatology, Hannover Medical School, Hannover, Germany

⁶Biomedical Research in Endstage and Obstructive Lung Disease Hannover (BREATH); Member of the German Center for Lung Research (DZL), Germany

,

Erika von Mutius

⁷Institute for Asthma- and Allergy Prevention (IAP), Helmholtz Zentrum Munich, German Research Center for Environmental Health (GmbH), Munich, Germany

⁸Dr von Hauner Children’s Hospital, Ludwig Maximilians University Munich, Munich, Germany

⁹Comprehensive Pneumology Center – Munich (CPC-M); Member of the German Center for Lung Research (DZL), Germany

,

Matthias Kopp

³Department of Paediatrics, Division of Paediatric Respiratory Medicine and Allergology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland

¹University Children’s Hospital, Division of Paediatric Pneumology and Allergology, University Medical Center Schleswig-Holstein Campus Luebeck, Luebeck, Germany

²Airway Research Center North (ARCN), Member of the German Center for Lung Research (DZL), Germany

› Institutsangaben

Abstract

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.

Zusammenfassung

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.

Key words

N2MBW - MBW - lung function - ventilation inhomogeneity - LCI - Turn Over

Schlüsselwörter

Auswaschverfahren - Ventilationsinhomogenität - N2MBW - MBW - Lungenfunktionsprüfung

Volltext

Referenzen

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