Cystic Fibrosis
Conditions
Keywords
Cystic fibrosis, Electrical Impedance Tomography
Brief summary
The goal of this feasibility study is to evaluate the ability of Electrical Impedance Tomography (EIT) for providing regional and quantitative information about the extent and nature of bronchial obstruction in patients with cystic fibrosis. It is not being conducted to diagnose, treat, prevent, or cure any kind of disease. In electrical impedance tomography low amplitude, low frequency current is applied on electrodes, and the resulting voltage is measured and used to computed the electrical properties of the interior of the chest as they change in time. The computed properties are used to form an image, which can then be used for monitoring and diagnosis.
Detailed description
The goal of this study is to evaluate the ability of Electrical Impedance Tomography (EIT) hardware and software in patients with cystic fibrosis (CF) for providing regional and quantitative information for identifying regions of obstruction and consolidation, and determine whether these measures will correlate with improvements seen after hospitalized treatment for a pulmonary exacerbation (PE). In particular, EIT will be used to identify regions of obstruction (air trapping) and consolidation comprised of atelectasis and airway occlusion (consequences of mucus plugging) in CF patients, and to determine whether EIT can demonstrate the beneficial effects of antibiotic treatment for CF patients with an acute PE by correlating changes in quantitative EIT measures with clinical measures known to improve following therapy, with patients serving as their own controls. Regional changes in air trapping and consolidation from pre to post treatment as indicated by the EIT images will be calculated, with subjects serving as their own control.
Interventions
DEVICECT scan
Applied only when part of the patient's standard care
Sponsors
Children's Hospital Colorado
University of Colorado, Denver
Colorado State University
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
2 Years to 21 Years
Healthy volunteers
Yes
Inclusion criteria
* Between the ages of 2 and 21 years (Groups 1 and 2) * Between the ages of 8 and 21 years (Group 3) * Healthy lungs (Group 1) * Clinical diagnosis of cystic fibrosis (Groups 2 and 3) * Clinically indicated for a pulmonary CT scan or will receive one as part of their routine care (Group 2) * Receiving IV antibiotics for a clinically diagnosed pulmonary exacerbation (Group 3)
Exclusion criteria
* Under age 24 months or over age 21. * No informed consent * Known congenital heart disease, arrythmia, or history of heart failure, admission to the intensive care unit, wearing a pacemaker or other surgical implant. * Pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity for identifying air trapping and consolidation | 2 years | The sensitivity and specificity of EIT for identifying regions of air trapping and consolidation will be assessed using the CT scan as the gold standard |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of the EIT computed spirometry values | 2 years | The accuracy of the spirometry measures computed from EIT images will be assessed by comparing to those from the pulmonary function tests |
| Correlation of EIT derived measures to patient improvement following IV antibiotics | 2 years | Changes in quantitative EIT measures will be correlated with clinical measures known to improve following therapy, patients serving as their own controls. |
Outcome results
None listed