Abstract
The Lung Clearance Index (LCI) is superior to spirometry in detecting early lung disease in Cystic Fibrosis and correlates with structural changes seen on CT-scans. The LCI has the potential to become a novel outcome parameter for clinical and research purposes. Longitudinal studies are required to further prove its prognostic value. Multi-centre design is likely to facilitate realisation of such studies.
Therefore the aim of the present study was to assess multi-centre feasibility and inter-centre variability of LCI measurements in healthy children and adolescents.
Measurements were performed using the EasyOne Pro, MBW module (ndd, Switzerland) by 8 participating CF centres. Marien Hospital Wesel, 7 is the upper limit of normal for the LCI.
The success rate of LCI measurements was 75.5%, leaving n=102 measurements for final analysis. Mean age (range) was 12.5 (5-20) years. Mean LCI (range) was 6.3 (6.0-6.5) and thus normal. Inter-centre variability was 2.9% (p=<0.05).
Our study demonstrates good multi-centre feasibility and low inter-centre variability of the LCI in healthy volunteers when measured with the EasyOne Pro MBW module. Our data are comparable to published single-centre data. However, central coordination, quality control, regular training and supervision during the entire study appear essential for successfully performing multi-centre trials.
This project was supported by Mukoviszidose eV Germany
- © 2011 ERS