Electrical Impedance Imaging of Patients With Cystic Fibrosis

NCT ID: NCT02524704

Last Updated: 2018-07-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 44 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-12-31

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.

Conditions

Cystic Fibrosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

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.

CT scan

Intervention Type: DEVICE

Applied only when part of the patient's standard care

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.

CT scan

Intervention Type: DEVICE

Applied only when part of the patient's standard care

Interventions

CT scan

Applied only when part of the patient's standard care

Intervention Type: DEVICE

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Hospital Colorado

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

Colorado State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer L Mueller, PhD

Role: PRINCIPAL_INVESTIGATOR

Colorado State University

References

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.

Reference Type: BACKGROUND

PMID: 23314771 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25203984 (View on PubMed)

Other Identifiers

ColoradoSU

Identifier Type: -

Identifier Source: org_study_id