Genesis Electrical Impedance Tomography (EIT): A Preliminary Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14-40
SponsorUniversity of Colorado, Denver

About this trial

The purpose of this study is to evaluate the Genesis Electrical Impedance Tomography (EIT) imaging system for use in pediatric respiratory disease populations including neuromuscular and bronchopulmonary dysplasia, as well as in age and height matched controls. The EIT does not use radiation, and is read through electrodes.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

2 weeks old - 40 years old

Premature infants with current age >2 weeks with a confirmed diagnosis of BPD based on NIH criteria

Or Chronic respiratory disease due to underlying neuromuscular disease

Or confirmed neuromuscular disease with an echo completed within the preceding 12 months of study participation of DMD or other diagnoses associated with mild cardiomyopathy.

Disqualifiers

<2 weeks of age

Congenital diaphragmatic hernia

Severe congenital heart disease

Significant genetic abnoralities

Trial population

pediatric respiratory disease populations including neuromuscular and bronchopulmonary dysplasia, as well as in age and height matched controls. Populations who will be undergoing cardiac catheterization for pulmonary vein stenosis, pulmonary hypertension and/or pulmonary artery stenosis

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

90 Participants
are grouped into 7 trial groups

7

Trial groups

See each trial group below.

Group A: Premature Infants
Group B: Chronic Respiratory Disease
Group C: Neuromuscular Disease
Group D: Healthy Controls
Group E: V/Q Scan validation
Group F: Premature Infants (Longitudinal Cohort)
Group G: Pulmonary Vein/Artery Stenosis

Trial outcomes

Primary outcomes

1

EIT imaging maps that provide regional information regarding 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
24 months

Secondary outcomes

1

Regional conductivity changes due to ventilation

Describe regional ventilation in pediatric respiratory disease populations including neuromuscular weakness, skeletal/chest wall disorders, and chronic airway and parenchymal lung disease including bronchopulmonary dysplasia. 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.

Time frame
24 months
2

Waveform for a mesh element

Time-series waveform indicated by time in seconds compared to Recon signal (au).

Time frame
24 months
3

Regional conductivity changes due to perfusion

This is a qualitative and quantitative aim. 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
24 months
4

Regional pulsatile perfusion imaging at the end of systole

Time frame
5 minutes

Other outcomes

Sponsors and contacts

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