Genesis Electrical Impedance Tomography (EIT): A Preliminary Study

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03797183
• Other study ID #: 18-1843
• Status: Recruiting
• Start date: May 3, 2019
• Est. completion date: November 30, 2024

Study information

• Verified date: January 2024
• Source: University of Colorado, Denver
• Contact: Emily DeBoer, MD
• Phone: 720-777-4953
• Email: emily.deboer[@]childrenscolorado.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Days to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Chronic Respiratory Disease
• Healthy
• Neuromuscular Diseases
• Premature Infant
• Respiration Disorders
• Respiratory Tract Diseases

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

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