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

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ClinicalTrials.gov Identifier: NCT05455671
Recruitment Status : Recruiting
First Posted : July 13, 2022
Last Update Posted : August 16, 2022
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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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.

Condition or disease
Cystic Fibrosis Healthy

Study Design
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Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real-Time Assessment of Lung Structure and Function in Children and Young Adults With CF Using Electrical Impedance Tomography
Actual Study Start Date : August 1, 2022
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : May 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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).

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   3 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children and young adults between 3 and 21 years old, with or without cystic fibrosis
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05455671


Contacts
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Contact: Jordana Jordana, MD 720-777-6550 jordana.hoppe@childrenscolorado.org
Contact: Allison Keck, BS 720-777-0734 allison.keck@childrenscolorado.org

Locations
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United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Jordana Hoppe, MD    720-777-6550    jordana.hoppe@childrenscolorado.org   
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Jordana Jordana, MD Children's Hospital Colorado
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT05455671    
Other Study ID Numbers: 22-0114
First Posted: July 13, 2022    Key Record Dates
Last Update Posted: August 16, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cystic Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
 Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases