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

NCT05455671 | Completed

• 1 other identifier: 22-0114
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cystic Fibrosis; Healthy

Outcome Measures

Primary Outcomes (1)

• Identification of air trapping and consolidation by EIT

  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.

  36 months

Secondary Outcomes (2)

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

  36 months

• Determination of structural changes in the lung by EIT

  36 months

Study Arms (3)

Cohort 1 - Healthy Controls

Persons, male or female, between the ages of 3 and 21 (inclusive) with healthy lungs, defined by no known or suspected chronic or temporary lung disease. A single study visit

Cohort 2 - CF Longitudinal

Persons, male or female, with CF, defined by two known disease-causing mutations and/or a sweat chloride value of \>60mmol/L, between the ages of 3 and 21 (inclusive).

Cohort 3 - CF Exacerbation

Persons, male or female, with CF, defined by two known disease-causing mutations and/or a sweat chloride value of \>60mmol/L, between the ages of 3 and 21 (inclusive), experiencing a pulmonary exacerbation requiring antibiotics.

Eligibility Criteria

• Age: 3 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children and young adults between 3 and 21 years old, with or without cystic fibrosis

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

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

Study Officials

• Jordana Jordana, MD

  Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: July 13, 2022
• Study Start: August 1, 2022
• Primary Completion: August 20, 2024
• Study Completion: August 20, 2024
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)