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

ABSTRACT: 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.

SUBMITTER: Stahl M

PROVIDER: S-EPMC7682699 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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

Stahl Mirjam M Joachim Cornelia C Kirsch Ines I Uselmann Tatjana T Yu Yin Y Alfeis Nadine N Berger Christiane C Minso Rebecca R Rudolf Isa I Stolpe Cornelia C Bovermann Xenia X Liboschik Lena L Steinmetz Alena A Tennhardt Dunja D Dörfler Friederike F Röhmel Jobst J Unorji-Frank Klaudia K Rückes-Nilges Claudia C von Stoutz Bianca B Naehrlich Lutz L Kopp Matthias V MV Dittrich Anna-Maria AM Sommerburg Olaf O Mall Marcus A MA

ERJ open research 20201026 4

<h4>Background</h4>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.<h4>Methods</h4>Following central training, 91 standardised nitrogen MBW investigations were pe ...[more]

PMID: 33263048

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Project description:BackgroundIn this pilot study we investigated daytime variation of multiple breath nitrogen washout (N2MBW) measures in children with clinically stable cystic fibrosis. To our knowledge the effect of time-of-day on multiple breath washout measures in patients with cystic fibrosis has not previously been reported. Furthermore, we assessed the influence of chest physiotherapy on N2MBW measures.MethodsTen school children with cystic fibrosis performed N2MBW followed by spirometry and plethysmography in the morning and afternoon at three visits that were one month apart. Chest physiotherapy was performed immediately before the afternoon measurements at visit 2 and immediately before morning and afternoon measurements at visit 3. The influence of time-of-day and chest physiotherapy on the measures was evaluated using linear mixed models.ResultsThere were adequate quality data from 8 children with median age (range) 9.6 (6.0; 15.1) years. Baseline lung clearance index (LCI) (range) was 9.0 (7.1; 13.0) and baseline FEV1% predicted was 97.5 (78.5; 117.9). No N2MBW measures were significantly influenced by time-of-day or chest physiotherapy. LCI (95% confidence interval) decreased non-significantly 0.05 (-0.32; 0.22) during the day and increased non-significantly 0.08 (-0.26; 0.42) after chest physiotherapy. All spirometric measures were unaffected by time-of-day and chest physiotherapy. For plethysmographic measures FRCpleth decreased significantly (p<0.01) 110 mL during the day, whereas a borderline significant (p = 0.046) decrease in ΔFRCpleth-MBW during the day and a borderline significant (p = 0.03) increase in TLC after CPT were observed.ConclusionThis study demonstrated that the time-of-day as well as chest physiotherapy performed immediately prior to N2MBW had no consistent or significant influence on N2MBW measures. However, we emphasize that further studies of the effect of both daytime variation and the effect of chest physiotherapy on multiple breath washout measures are warranted.

Dataset Information

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

Publications

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

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