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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
7
Trial groupsSee each trial group below.
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Waveform for a mesh element
Time-series waveform indicated by time in seconds compared to Recon signal (au).
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.
Regional pulsatile perfusion imaging at the end of systole
Sponsors and contacts
Click on the lead sponsor to view all of their trials.