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Completed

NCT Number: NCT02524704

Electrical Impedance Imaging of Patients With Cystic Fibrosis

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.

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Key information

Conditions

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

Age range

2 year–21 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CT Scan

Device

Applied only when part of the patient's standard care

Primary outcomes

  1. Sensitivity and specificity for identifying air trapping and consolidation

    Time frame: 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 outcomes

  1. Accuracy of the EIT computed spirometry values

    Time frame: 2 years

    The accuracy of the spirometry measures computed from EIT images will be assessed by comparing to those from the pulmonary function tests

  2. Correlation of EIT derived measures to patient improvement following IV antibiotics

    Time frame: 2 years

    Changes in quantitative EIT measures will be correlated with clinical measures known to improve following therapy, patients serving as their own controls.

Sponsors and collaborators

Lead sponsor

Colorado State University

Other

Collaborators

  • Children's Hospital Colorado
  • University of Colorado, Denver

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 17, 2015
Registry last updated
Jul 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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