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NCT Number: NCT07247474

Triple EIT (Electrical Impedance Tomography)

This study plans to learn more about ways to look at participant's lungs using new machines called Electrical Impedance Tomography (EIT). The EIT does not use harmful radiation like CT or x-ray. It is read through electrodes like using EKG reading heartbeats.

The investigators want to compare the results of patients who have chronic respiratory disease to patients without chronic respiratory disease to learn more about lung structure and composition.

Recruiting

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Key information

Conditions

Neonates and Preterm Infants Cardiopulmonary

Age range

2 week–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Allison Keck

CONTACT

[email protected]

720-777-0734

Katelyn Enzer, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 2 weeks to 25 years of age
  • evidence of cardiopulmonary disease including, but not limited to:
  • Post-prematurity respiratory disease
  • Congenital diaphragmatic hernia
  • Pulmonary Hypertension
  • Congenital heart disease
  • Respiratory failure
  • Neuromuscular Disease
  • Developmental or congenital lung disease

OR matched healthy controls (born at term gestation (>36 weeks gestational age) with no cardiopulmonary disease)

Exclusion criteria

  • <2 weeks of age
  • Anything that interferes with lead placement on the chest wall (such as, dermatologic conditions, multiple chest tubes, anatomic abnormality, or large dressings that cannot be moved)
  • No informed consent
  • Pregnant or lactating
  • Pacemaker or other metal intrathoracic surgical implant (causes noise in the data)

Treatment and study plan

Electrical impedance tomography (EIT)

Device

Electrical impedance tomography (EIT) is a noninvasive and non-ionizing imaging technique that describes lung ventilation and perfusion

Primary outcomes

  1. EIT Imaging Maps that provide information about regional ventilation and perfusion of the lung

    Time frame: 4 hours

    These images will be analyzed both visually for qualitative abnormalities and through quantitative pixel analysis that can provide information regarding lung volume, blood volume, and changes in either based on respiratory cycle, cardiac cycle, or intervention. Areas of low ventilation (atelectasis and consolidation) will be identified.

Secondary outcomes

  1. Regional Conductivity Due to Ventilation

    Time frame: 4 hours

    This is a qualitative aim and will summarize EIT images pictorially. Pixel densities will be evaluated for normality and summarized as mean (SD) or median (interquartile range). EIT images will be qualitatively compared between cases and controls. Outcome metrics may be generated to measure things such as ventilation heterogeneity

  2. Regional Conductivity Due to Perfusion

    Time frame: 4 hours

    This is a qualitative and quantitative aim that will only be performed using the ACT5 EIT system. Results will qualitatively compare EIT images with CXR and CT scan images when available. Images will be displayed side by side and interpreted by both the clinician and the EIT study staff. Various summary measures of EIT outcomes will be calculated including pixel heterogeneity, summary changes over tidal breath and variation between tidal peaks. Pearson and Spearman correlation will be calculated between summary EIT outcomes and continuous primary clinical values. Linear and logistic regression will be used to estimate associations (with 95% CI) between EIT measures and clinical outcomes. Summary data will be presented in tables and figures using basic descriptive statistics stratified by study group.

  3. Comparison of Ventilation and Perfusion Ratio

    Time frame: 4 hours

    In participants with both ventilation and perfusion metrics from the ACT5 EIT system, a regional comparison of ventilation and perfusion will be generated. These values will indicate whether a segment of the lung has relatively more or less ventilation or perfusion.

Study contacts

Contact information is provided by the study sponsor or research team.

Allison Keck, BS

CONTACT

[email protected]

720-777-0734

Katelyn Enzer, MD

CONTACT

[email protected]

7207779137

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Colorado State University

Registry information

Official study title

Characterizing the Evolution of Neonatal Lung Disease Throughout Infancy and Childhood Using Electrical Impedance Tomography: A Pilot Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Nov 25, 2025
Registry last updated
Feb 23, 2026

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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