| Popis: |
Background: Early ventilation inhomogeneity in cystic fibrosis (CF) lung disease can be detected by multiple-breath washout (MBW)-derived lung clearance index (LCI), suggesting this parameter as sensitive endpoint in interventional trials in preschoolers. However, the feasibility of multicenter LCI in awake children aged 2-6 years has not been determined. Therefore, we investigated the feasibility of LCI in preschool children with and without CF across five sites. Methods: Following central training, 89 standardized N2-MBW measurements were performed in 73 awake children (16 controls, 45 with CF, 3 with primary ciliary dyskinesia (PCD) and 9 with other lung diseases), mean age 4.6±0.9 years at investigation, using the Exhalyzer D with spiroware 3.2.1 (Ecomedics, Duernten, Switzerland) across five centers in Germany. Data were analyzed centrally for quality and abnormalities of ventilation. Results: Overall success rate of LCI measurements was 82.0% ranging from 70.0% (Giessen), 70.6% (Berlin), 81.0% (Hannover), 87.5% (HD) to 94.1% (Lubeck) across study sites. LCI was increased in patients with CF (p 0.05) compared to controls. Conclusion: Our results support feasibility of LCI as multicenter endpoint in clinical trials in awake preschoolers with CF. |
