Clinical trial NCT02524704: Electrical Impedance Imaging of Patients With Cystic Fibrosis
Official title: Electrical Impedance Tomography (EIT): A Non-radiating Functional Imaging for Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Keywords: Cystic fibrosis
Electrical Impedance Tomography
Lead sponsor: Colorado State University
Sponsor class: OTHER
Collaborators: name: Children's Hospital Colorado
name: University of Colorado, Denver
First posted: 2015-08-17
Enrollment: 44
Sex: ALL
Minimum age (years): 2
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: There are three groups in this study. Group 1 consists of healthy controls between the ages of 2 and 21. Group 2 consists of persons with cystic fibrosis between the ages of 2 and 21 who are either clinically indicated for a pulmonary CT scan or will receive one as part of their routine care. Group 3 consists of persons with cystic fibrosis between the ages of 8 and 21 who are being started on IV antibiotics for a clinically diagnosed pulmonary exacerbation.

Sampling is by convenience or invitation to volunteer.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity and specificity for identifying air trapping and consolidation
timeFrame: 2 years
Secondary outcomes:
measure: Accuracy of the EIT computed spirometry values
timeFrame: 2 years
measure: Correlation of EIT derived measures to patient improvement following IV antibiotics
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Colorado State University
name: Jennifer L Mueller, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hamilton SJ, Mueller JL. Direct EIT reconstructions of complex admittivities on a chest-shaped domain in 2-D. IEEE Trans Med Imaging. 2013 Apr;32(4):757-69. doi: 10.1109/TMI.2012.2237389. Epub 2013 Jan 9.
citation: Herrera CN, Vallejo MF, Mueller JL, Lima RG. Direct 2-D reconstructions of conductivity and permittivity from EIT data on a human chest. IEEE Trans Med Imaging. 2015 Jan;34(1):267-74. doi: 10.1109/TMI.2014.2354333. Epub 2014 Sep 4.