Multicentre feasibility of multiple-breath washout in preschool children with cystic fibrosis and other lung diseases

Stahl, Mirjam; Joachim, Cornelia; Kirsch, Ines; Uselmann, Tatjana; Yu, Yin; Alfeis, Nadine; Berger, Christiane; Minso, Rebecca; Rudolf, Isa; Stolpe, Cornelia; Bovermann, Xenia; Liboschik, Lena; Steinmetz, Alena; Tennhardt, Dunja; Dörfler, Friederike; Röhmel, Jobst; Unorji-Frank, Klaudia; Rückes-Nilges, Claudia; von Stoutz, Bianca; Naehrlich, Lutz; ... (2020). Multicentre feasibility of multiple-breath washout in preschool children with cystic fibrosis and other lung diseases. ERJ Open Research, 6(4) European Respiratory Society 10.1183/23120541.00408-2020

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Background: Multiple-breath washout (MBW)-derived lung clearance index (LCI) detects early cystic fibrosis (CF) lung disease. LCI was used as an end-point in single- and multicentre settings at highly experienced MBW centres in preschool children. However, multicentre feasibility of MBW in children aged 2-6 years, including centres naïve to this technique, has not been determined systematically.

Methods: Following central training, 91 standardised nitrogen MBW investigations were performed in 74 awake preschool children (15 controls, 46 with CF, and 13 with other lung diseases), mean age 4.6±0.9 years at investigation, using a commercially available device across five centres in Germany (three experienced, two naïve to the performance in awake preschool children) with central data analysis. Each MBW investigation consisted of several measurements.

Results: Overall success rate of MBW investigations was 82.4% ranging from 70.6% to 94.1% across study sites. The number of measurements per investigation was significantly different between sites ranging from 3.7 to 6.2 (p<0.01), while the mean number of successful measurements per investigation was comparable with 2.1 (range, 1.9 to 2.5; p=0.46). In children with CF, the LCI was increased (median 8.2, range, 6.7-15.5) compared to controls (median 7.3, range 6.5-8.3; p<0.01), and comparable to children with other lung diseases (median 7.9, range, 6.6-13.9; p=0.95).

Conclusion: This study demonstrates that multicentre MBW in awake preschool children is feasible, even in centres previously naïve, with central coordination to assure standardised training, quality control and supervision. Our results support the use of LCI as multicentre end-point in clinical trials in awake preschoolers with CF.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Gynaecology, Paediatrics and Endocrinology (DFKE) > Clinic of Paediatric Medicine

UniBE Contributor:

Kopp, Matthias Volkmar

Subjects:

600 Technology > 610 Medicine & health

ISSN:

2312-0541

Publisher:

European Respiratory Society

Language:

English

Submitter:

Karen Lidzba

Date Deposited:

14 Jan 2021 15:14

Last Modified:

16 Jan 2021 07:23

Publisher DOI:

10.1183/23120541.00408-2020

PubMed ID:

33263048

BORIS DOI:

10.48350/150656

URI:

https://boris.unibe.ch/id/eprint/150656

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