Electrical Impedance Imaging of Patients With Cystic Fibrosis

NCT02524704 | Completed DMC

• 1 other identifier: ColoradoSU
• Study Type: observational
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cystic Fibrosis

Keywords

Cystic fibrosis; Electrical Impedance Tomography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Accuracy of the EIT computed spirometry values

  2 years

• Correlation of EIT derived measures to patient improvement following IV antibiotics

  2 years

Study Arms (3)

Healthy controls

Subjects between the ages of 2 and 21 with healthy lungs. Electrical impedance tomography data will be collected during tidal breathing, during 5 to 10 seconds of breath holding, and during FEV1 and FEF 25-75 spirometry maneuvers for subjects over age 8.

CF patients scheduled for a CT scan

Subjects with CF between the ages of 2 and 21 who are either clinically indicated for a CT scan of the lungs or are scheduled for a pulmonary CT scan as part of their routine care. Electrical impedance tomography data data will be collected during tidal breathing, during 5 to 10 seconds of breath holding, during forced expiratory volume in 1 second (FEV1) and forced expiratory flow (FEF) 25-75 spirometry maneuvers for subjects over age 8, and immediately before or after pulmonary CT scanning.

Device: CT scan

CF patients with pulmonary exacerbation

Subjects with CF between the ages of 8 and 21 who are being started on intravenous (IV) antibiotics for a clinically diagnosed pulmonary exacerbation. Electrical impedance tomography data data will be collected during tidal breathing, during 5 to 10 seconds of breath holding, during FEV1 and FEF 25-75 spirometry maneuvers upon admission for a pulmonary exacerbation and following 7 to 14 days hospitalized treatment including IV antibiotics. Further data will be collected at the same time with CT scanning if the scan is part of the patient's standard of care.

Device: CT scan

Interventions

CT scan DEVICE

Applied only when part of the patient's standard care

CF patients scheduled for a CT scan; CF patients with pulmonary exacerbation

Eligibility Criteria

• Age: 2 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Colorado State University: lead
• Children's Hospital Colorado: collaborator
• University of Colorado, Denver: collaborator

Related 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.

  PMID: 23314771 BACKGROUND

• 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.

  PMID: 25203984 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Jennifer L Mueller, PhD

  Colorado State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2015
• First Posted: August 17, 2015
• Study Start: March 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 17, 2018

Record last verified: 2016-07