Genesis Electrical Impedance Tomography (EIT): A Preliminary Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Premature Infant, Chronic Respiratory Disease, Neuromuscular Diseases, Healthy. Basic parameters: 14 Days — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Associations Between EIT and Clinical Measures During Standard of Care Procedures in Patients With Respiratory Disease: A Preliminary Study
Overview
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.
Primary outcome measures
- EIT imaging maps that provide regional information regarding ventilation and perfusion of the lung. [Time frame: 24 months]
Secondary outcome measures (5)
- Regional conductivity changes due to ventilation [Time frame: 24 months]
- Waveform for a mesh element [Time frame: 24 months]
- Regional conductivity changes due to perfusion [Time frame: 24 months]
- Regional pulsatile perfusion imaging at the end of systole [Time frame: 5 minutes]
- Power waveform (computed as the inner product of measured voltages and applied currents) [Time frame: 24 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Children's Hospital Colorado — Aurora
Identifiers
NCT: NCT03797183 · 18-1843