Genesis Electrical Impedance Tomography (EIT): A Preliminary Study

University of Colorado Denver (CU Denver)

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT03797183

18-1843

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 14 days to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

90 participants in 7 patient groups

Premature Infants

Description:

Premature infants \>1 month of age currently hospitalized with bronchopulmonary dysplasia (BPD) without acute respiratory infection

Chronic Respiratory Disease

Description:

Participants ages \>1 month-21 years with chronic respiratory disease due to underlying neuromuscular disease

Neuromuscular Disease

Description:

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

Description:

Age and height matched healthy controls

V/Q Scan validation

Description:

Adults or children who are having or have recently had a V/Q scan

Premature Infants (Longitudinal Cohort)

Description:

Premature infants ages 2 weeks to 1 year with diagnosed or suspected bronchopulmonary dysplasia

Pulmonary Vein/Artery Stenosis

Description:

Children age 2 months to 18 years, who will be undergoing cardiac catheterization for pulmonary vein stenosis, pulmonary hypertension and/or pulmonary artery stenosis