Genesis Electrical Impedance Tomography (EIT): A Preliminary Study

NCT03797183 | Recruiting

• 1 other identifier: 18-1843
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Premature Infant; Chronic Respiratory Disease; Neuromuscular Diseases; Healthy; Bronchopulmonary Dysplasia; Pulmonary Vein Stenoses

Outcome Measures

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.

  24 months

Secondary Outcomes (5)

• Regional conductivity changes due to ventilation

  24 months

• Waveform for a mesh element

  24 months

• Regional conductivity changes due to perfusion

  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

Study Arms (7)

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

Eligibility Criteria

• Age: 14 Days - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Premature Birth; Neuromuscular Diseases; Bronchopulmonary Dysplasia; Stenosis, Pulmonary Vein

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Nervous System Diseases; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Emily DeBoer, MD

CONTACT

720-777-4953; emily.deboer@childrenscolorado.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2018
• First Posted: January 9, 2019
• Study Start: May 3, 2019
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)