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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Healthy; Cystic Fibrosis

Study type: Observational

Funder types: Other

Identifiers

NCT05455671

22-0114

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 3 to 21 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

48 participants in 3 patient groups

Cohort 1 - Healthy Controls

Description:

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

Description:

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

Description:

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.