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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05455671
• Other study ID #: 22-0114
• Status: Recruiting
• Start date: August 1, 2022
• Est. completion date: May 2025

Study information

• Verified date: September 2023
• Source: University of Colorado, Denver
• Contact: Jordana Jordana, MD
• Phone: 720-777-6550
• Email: jordana.hoppe[@]childrenscolorado.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Healthy

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Determining utility of EIT information in response to treatment for a pulmonary exacerbation	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).	36 months
Secondary	Determination of structural changes in the lung by EIT	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.	36 months