Genesis Electrical Impedance Tomography (EIT): A Preliminary Study

The Associations Between EIT and Clinical Measures During Standard of Care Procedures in Patients With Respiratory Disease: A Preliminary Study

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy; Neuromuscular Diseases; Bronchopulmonary Dysplasia; Premature Infant; Chronic Respiratory Disease; Pulmonary Vein Stenoses

Detailed Description

The purpose of this study is to evaluate EIT for use in pediatric respiratory disease populations including neuromuscular and bronchopulmonary dysplasia, as well as in age and height matched controls.

Researchers will use EIT to determine changes in regional ventilation with pulmonary interventions including airway clearance and invasive and noninvasive ventilation in a pediatric respiratory disease population.

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Emily DeBoer, MD; Phone Number: 720-777-4953; Email: emily.deboer@childrenscolorado.org

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Children's Hospital Colorado
      • Contact: Allison Keck; Phone Number: 720-777-0734; Email: allison.keck@childrenscolorado.org
      • Contact: Emily DeBoer, MD; Phone Number: 720-777-4953; Email: emily.deboer@childrenscolorado.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 36 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study 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

Description

Inclusion Criteria:

• 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.
• have had a VQ scan
• will be undergoing cardiac catherization for for pulmonary vein stenosis, pulmonary hypertension and/or pulmonary artery stenosis
• Or healthy controls

Exclusion Criteria:

• <2 weeks of age
• Congenital diaphragmatic hernia
• Severe congenital heart disease
• Significant genetic abnoralities
• Anything that interferes with lead placement on the chest wall
• Unwilling/refusal to sign consent
• Pregnant or lactating
• Pacemaker of other surgical implant and spinal implant (causes noise in the data)
• Moderate to severe cardiomyopathy
• Patients with temporary cognitive disability due to illness

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort
Premature Infants; Premature infants >1 month of age currently hospitalized with bronchopulmonary dysplasia (BPD) without acute respiratory infection
Chronic Respiratory Disease; Participants ages >1 month-21 years with chronic respiratory disease due to underlying neuromuscular disease
Neuromuscular Disease; Participants ages 21-40 years with confirmed neuromuscular disease with an echo completed within the preceding 12 months of study participation of Duchenne muscular dystrophy (DMD) or other diagnoses associated with mild cardiomyopathy
Healthy Controls; Age and height matched healthy controls
V/Q Scan validation; Adults or children who are having or have recently had a V/Q scan
Premature Infants (Longitudinal Cohort); Premature infants ages 2 weeks to 1 year with diagnosed or suspected bronchopulmonary dysplasia
Pulmonary Vein/Artery Stenosis; Children age 2 months to 18 years, who will be undergoing cardiac catheterization for pulmonary vein stenosis, pulmonary hypertension and/or pulmonary artery stenosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 months
Waveform for a mesh element	Time-series waveform indicated by time in seconds compared to Recon signal (au).	24 months
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.	24 months
Regional pulsatile perfusion imaging at the end of systole		5 minutes
Power waveform (computed as the inner product of measured voltages and applied currents)		24 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2019
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: December 28, 2018
• First Submitted That Met QC Criteria: January 4, 2019
• First Posted (Actual): January 9, 2019

Study Record Updates

• Last Update Posted (Estimated): November 13, 2025
• Last Update Submitted That Met QC Criteria: November 11, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Respiratory Tract Diseases; Lung Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury; Ventilator-Induced Lung Injury; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Stenosis, Pulmonary Vein; Premature Birth; Neuromuscular Diseases; Bronchopulmonary Dysplasia
• Other Study ID Numbers: 18-1843

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No