Genesis Electrical Impedance Tomography (EIT): A Preliminary Study

Sponsor
University of Colorado, Denver (Other)
Overall Status
Recruiting
CT.gov ID
NCT03797183
Collaborator
(none)
48
1
54.9
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Study Details

Study Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
48 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
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Nov 30, 2023

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. EIT imaging maps that provide regional information regarding ventilation and perfusion of the lung. [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 [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 [24 months]

    Time-series waveform indicated by time in seconds compared to Recon signal (au).

  3. Regional conductivity changes due to perfusion [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 [5 minutes]

  5. Power waveform (computed as the inner product of measured voltages and applied currents) [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
31 Days to 40 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • 4 weeks old - 40 years old

  • Premature infants with current age >1 month 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:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Children's Hospital Colorado Aurora Colorado United States 80045

Sponsors and Collaborators

  • University of Colorado, Denver

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT03797183
Other Study ID Numbers:
  • 18-1843
First Posted:
Jan 9, 2019
Last Update Posted:
Jan 27, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 27, 2022