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Genesis Electrical Impedance Tomography (EIT): A Preliminary Study

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ClinicalTrials.gov Identifier: NCT03797183
Recruitment Status : Recruiting
First Posted : January 9, 2019
Last Update Posted : December 15, 2022
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease
Premature Infant Chronic Respiratory Disease Neuromuscular Diseases Healthy Bronchopulmonary Dysplasia

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.

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Associations Between EIT and Clinical Measures During Standard of Care Procedures in Patients With Respiratory Disease: A Preliminary Study
Actual Study Start Date : May 3, 2019
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : November 30, 2023


Group/Cohort
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



Primary Outcome Measures :
  1. EIT imaging maps that provide regional information regarding ventilation and perfusion of the lung. [ Time Frame: 24 months ]
    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.


Secondary Outcome Measures :
  1. Regional conductivity changes due to ventilation [ Time Frame: 24 months ]

    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.


  2. Waveform for a mesh element [ Time Frame: 24 months ]
    Time-series waveform indicated by time in seconds compared to Recon signal (au).

  3. Regional conductivity changes due to perfusion [ Time Frame: 24 months ]
    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.

  4. Regional pulsatile perfusion imaging at the end of systole [ Time Frame: 5 minutes ]
  5. Power waveform (computed as the inner product of measured voltages and applied currents) [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   14 Days to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
pediatric respiratory disease populations including neuromuscular and bronchopulmonary dysplasia, as well as in age and height matched controls.
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.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03797183


Contacts
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Contact: Emily DeBoer, MD 720-777-4953 emily.deboer@childrenscolorado.org

Locations
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United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Emily DeBoer, MD    720-777-4953    emily.deboer@childrenscolorado.org   
Contact: Allison Keck    720-777-0734    allison.keck@childrenscolorado.org   
Sponsors and Collaborators
University of Colorado, Denver
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03797183    
Other Study ID Numbers: 18-1843
First Posted: January 9, 2019    Key Record Dates
Last Update Posted: December 15, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiration Disorders
Respiratory Tract Diseases
Bronchopulmonary Dysplasia
Neuromuscular Diseases
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Nervous System Diseases