Real-Time Assessment of Lung Structure and Function in Children and Young Adults With CF Using Electrical Impedance Tomography

The purpose of this study is to determine the ability of electrical impedance tomography (EIT) to identify structural and functional physiological changes that occur with disease progression in cystic fibrosis patients. The investigators also aim to determine whether EIT can serve as an alternative for CT to identify regions of air trapping and consolidation, whether EIT can provide clinically useful information about response to treatment for an acute PE, and whether EIT can provide longitudinal information about structural changes in the lung.

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Key information

Conditions

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

Age range

3 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Cohort 1:

Age 3-21 years
Male or female
Healthy subjects with no known or suspected chronic or temporary lung disease

Cohort 2:

Age 3-21 years
Male or female
CF as diagnosed based on sweat chloride value(>60 mmol/L) or two known disease causing mutations

Cohort 3:

Age 3-21 years
Male or female
CF as diagnosed based on sweat chloride value (>60 mmol/L) or two known disease causing mutations
Experiencing a protocol defined pulmonary exacerbation and being started on oral or intravenous antibiotics

Exclusion criteria

Unwilling/refusal to sign consent
Known congenital heart disease, arrhythmia, or history of heart failure
Wearing a pacemaker or a metallic surgical implant in the chest
History of infection with Burkholderia cepacia
Developmental delays that could result in an inability to complete study procedures

Treatment and study plan

Primary outcomes

Identification of air trapping and consolidation by EIT

Time frame: 36 months

The detection task for identifying air trapping and consolidation is to determine by inspection regions of EIT VQ index significantly lower than the surrounding lung region, with actual numbers or relative differences to be determined as part of this study in the correlation analysis to CT scans.

Secondary outcomes

Determining utility of EIT information in response to treatment for a pulmonary exacerbation

Time frame: 36 months

Individual outcome measures (CFCS, LCI , PFT, and EIT measures) will be evaluated using paired t-tests, and the corresponding t-statistics from each of the tests will be used as measures of effect size for comparison. In addition, all of the clinical outcomes can be compared statistically using a joint model approach (this is the same model that is referenced in Q3 below).
Determination of structural changes in the lung by EIT

Time frame: 36 months

The EIT-derived global VQ indices, FEV1, FEV1/FVC, FVC, and extent of air trapping and consolidation will be studied longitudinally and compared to LCIs, PFTs, and CT scans when available to assess the ability of EIT to identify structural and reversible physiological changes that occur with disease progression. To estimate the change in the EIT measures of global VQ, air trapping and consolidation, and EIT-derived PFT outputs over time, a random coefficient model with an intercept and slope fit for each subject with at least two measurements over the 3 years will be used. A bivariate version of the random coefficients model will be fit to address whether the EIT outcome variable is associated with the spirometer PFT outputs, LCI, and CFCS while accounting for repeated measures.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Jul 13, 2022
Registry last updated: Nov 13, 2025

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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