Health TrialsbyHealthPanel

Triple EIT (Electrical Impedance Tomography)

ConditionsNeonates and Preterm InfantsCardiopulmonary
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-25
SponsorUniversity of Colorado, Denver

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

2 weeks to 25 years of age

Post-prematurity respiratory disease

Congenital diaphragmatic hernia

Pulmonary Hypertension

Disqualifiers

<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

Trial population

Children's Hospital Colorado

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Electrical impedance tomography (EIT)

    Device

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

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Cardiopulmonary disease1 intervention
Group B: Control1 intervention

Trial outcomes

Primary outcomes

1

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

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.

Time frame
4 hours

Secondary outcomes

1

Regional Conductivity Due to Ventilation

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

Time frame
4 hours
2

Regional Conductivity Due to Perfusion

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.

Time frame
4 hours
3

Comparison of Ventilation and Perfusion Ratio

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.

Time frame
4 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

Colorado State University

Collaborator

Source ClinicalTrials.gov
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