Electrical Impedance Imaging of Patients With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Electrical Impedance Tomography (EIT): A Non-radiating Functional Imaging for Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02524704
• Other study ID #: ColoradoSU
• Status: Completed
• Start date: March 2015
• Est. completion date: December 2016

Study information

• Verified date: July 2016
• Source: Colorado State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Device:
• CT scan
Applied only when part of the patient's standard care

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Colorado State University	Children's Hospital Colorado, University of Colorado, Denver

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity for identifying air trapping and consolidation	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	2 years
Secondary	Accuracy of the EIT computed spirometry values	The accuracy of the spirometry measures computed from EIT images will be assessed by comparing to those from the pulmonary function tests	2 years
Secondary	Correlation of EIT derived measures to patient improvement following IV antibiotics	Changes in quantitative EIT measures will be correlated with clinical measures known to improve following therapy, patients serving as their own controls.	2 years