Share This Article:

Developing Customized Evaluation Software for Clinical Trials: An Example with Obstructive Lung Diseases

Full-Text HTML Download Download as PDF (Size:398KB) PP. 103-107
DOI: 10.4236/eng.2013.510B021    2,370 Downloads   3,225 Views  

ABSTRACT

Corresponding customized software tool is usually unavailable, which increases the time and workload for evaluating the results of a clinical trial. In the present paper, we demonstrate the development process of a customized software for one clinical trial on patients with obstructive lung disease. Over hundred patients and volunteers as controlled were included in the clinical trial. They were examined by spirometry and EIT in a seated position during spontaneous tidal breathing. Subsequently, standard vital capacity maneuver and forced full expiration maneuver were performed. In order to evaluate the offline data, a customized software was developed. The requirements of the software were defined by investigators. The software was then tested on patients’ data and refined based on feedbacks of the investigators. We finalized the customized software with analysis of various disease-specific parameters and indices. Compared to the data process with device specific programs and other commercial software, the customized software is more flexible, user-friendly and extendable. As conclusion, customized software simplifies the evaluation process distinctly and helps physicians to focus on study design and result interpretation.



Conflicts of Interest

The authors declare no conflicts of interest.

Cite this paper

Zhao, Z. , Vogt, B. , Frerichs, I. , Müller-Lisse, U. and Möller, K. (2013) Developing Customized Evaluation Software for Clinical Trials: An Example with Obstructive Lung Diseases. Engineering, 5, 103-107. doi: 10.4236/eng.2013.510B021.

References

[1] Z. Zhao, et al., “Regional Ventilation in Cystic Fibrosis Measured by Electrical Impedance Tomography,” Journal of Cystic Fibrosis, Vol. 11, 2012, pp. 412-418. http://dx.doi.org/10.1016/j.jcf.2012.03.011
[2] B. Vogt, et al., “Spatial and Temporal Heterogeneity of Regional Lung Ventilation Determined by Electrical Impedance Tomography during Pulmonary Function Testing,” Journal of Applied Physiology, Vol. 113, 2012, pp. 1154-1161. http://dx.doi.org/10.1152/japplphysiol.01630.2011
[3] Z. Zhao, et al., “Evaluation of an Electrical Impedance Tomography-Based Global Inhomogeneity Index for Pulmonary Ventilation Distribution,” Intensive Care Medicine, Vol. 35, 2009, pp. 1900-1906. http://dx.doi.org/10.1007/s00134-009-1589-y
[4] B. H. Brown, et al., “Cardiac and Respiratory Related Electrical Impedance Changes in the Human Thorax,” IEEE Transactions on Biomedical Engineering, Vol. 41, 1994, pp. 729-734. http://dx.doi.org/10.1109/10.310088
[5] I. Frerichs, et al., “Gravity Effects on Regional Lung Ventilation Determined by Functional EIT during Parabolic Flights,” Journal of Applied Physiology, Vol. 91, 2001, pp. 39-50.
[6] Z. Zhao, et al., “PEEP Titration Guided by Ventilation Homogeneity: A Feasibility Study Using Electrical Impedance Tomography,” Critical Care, Vol. 14, 2010, p. R8. http://dx.doi.org/10.1186/cc8860
[7] E. L. Costa, et al., “Real-Time Detection of Pneumothorax Using Electrical Impedance Tomography,” Critical Care Medicine, Vol. 36, 2008, pp. 1230-1238. http://dx.doi.org/10.1097/CCM.0b013e31816a0380
[8] B. M. Eyuboglu, et al., “Application of Electrical Impedance Tomography in Diagnosis of Emphysema: A Clinical Study,” Physiological Measurement, Vol. 16, 1995, pp. A191-A211. http://dx.doi.org/10.1088/0967-3334/16/3A/018
[9] K. Lowhagen, et al., “Regional Intratidal Gas Distribution in Acute Lung Injury and Acute Respiratory Distress Syndrome-Assessed by Electric Impedance Tomography,” Minerva Anestesiologica, Vol. 76, 2010, pp. 1024-1035.
[10] A. Adler and W. R. Lionheart, “Uses and Abuses of EI- DORS: An Extensible Software Base for EIT,” Physiological Measurement, Vol. 27, 2006, pp. S25-42. http://dx.doi.org/10.1088/0967-3334/27/5/S03
[11] D. Steinmann, et al., “Electrical Impedance Tomography to Confirm Correct Placement of Double-Lumen Tube: A Feasibility Study,” British Journal of Anaesthesia, Vol. 101, 2008, pp. 411-418. http://dx.doi.org/10.1093/bja/aen166
[12] I. G. Bikker, et al., “Lung Volume Calculated from Electrical Impedance Tomography in ICU Patients at Different PEEP Levels,” Intensive Care Medicine, Vol. 35, 2009, pp. 1362-1367. http://dx.doi.org/10.1007/s00134-009-1512-6

  
comments powered by Disqus

Copyright © 2018 by authors and Scientific Research Publishing Inc.

Creative Commons License

This work and the related PDF file are licensed under a Creative Commons Attribution 4.0 International License.