Clinical trial NCT03797183: Genesis Electrical Impedance Tomography (EIT): A Preliminary Study
Official title: The Associations Between EIT and Clinical Measures During Standard of Care Procedures in Patients With Respiratory Disease: A Preliminary Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Premature Infant
Chronic Respiratory Disease
Neuromuscular Diseases
Healthy
Bronchopulmonary Dysplasia
Pulmonary Vein Stenoses
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2019-01-09
Enrollment: 90
Sex: ALL
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: EIT imaging maps that provide regional information regarding ventilation and perfusion of the lung.
timeFrame: 24 months
Secondary outcomes:
measure: Regional conductivity changes due to ventilation
timeFrame: 24 months
measure: Waveform for a mesh element
timeFrame: 24 months
measure: Regional conductivity changes due to perfusion
timeFrame: 24 months
measure: Regional pulsatile perfusion imaging at the end of systole
timeFrame: 5 minutes
measure: Power waveform (computed as the inner product of measured voltages and applied currents)
timeFrame: 24 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
References: