Electrical Impedance Imaging of Patients on Mechanical Ventilation

Pilot Study: Electrical Impedance Imaging of Patients on Mechanical Ventilation With Lung Pathology

The goal of this study is to evaluate the sensitivity and specificity of Electrical Impedance Tomography (EIT) as a bedside diagnostic tool for lung pathologies in patients who are mechanically ventilated. In electrical impedance tomography low amplitude, low frequency current is applied on electrodes, and the resulting voltage is measured and used to computed the electrical properties of the interior of the chest as they change in time. The computed properties are used to form an image, which can then be used for monitoring and diagnosis.

Study Overview

• Status: Completed
• Conditions: Pneumothorax; Emphysema; Hyperinflation; Acute Respiratory Distress Syndrome; Pulmonary Edema; Pleural Effusion; Atelectasis; Pulmonary Contusion
• Intervention / Treatment: Device: Mechanical Ventilation; Device: CT Scan

Detailed Description

The goal of this study is to characterize the ability of the electrical impedance tomography system (hardware and software) to distinguish between lung pathologies by assessing the sensitivity and specificity as well as the overall agreement with the CT scan in terms of spatial resolution. The study will test, as well as refine, the mathematical algorithms needed to create meaningful outputs on adult patients receiving mechanical ventilation and who also have received or will be receiving a CT scan as part of their standard of care.

• Study Type: Observational
• Enrollment (Actual): 2

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Loveland, Colorado, United States, 80538
      • Medical Center of the Rockies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Mechanically ventilated adult intensive care unit patients at Medical Center of the Rockies with pulmonary pathology who have received or will be receiving a CT scan as part of their standard care

Description

Inclusion Criteria:

• Patients admitted to the ICU at Medical Center of the Rockies and on mechanical ventilation
• Age greater than or equal to 18
• Computed Tomography of the chest during normal course of hospital admission

Exclusion Criteria:

• Age <18
• Any skin disorder that would prevent placement of the electrodes on the chest wall
• Hemodynamic instability prohibiting patient from being moved to place the device

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mechanical ventilation; Hospitalized adult patients with lung injury receiving mechanical ventilation and who also have received or will receive a CT scan as part of their standard care	Device: Mechanical Ventilation; Subjects will receive mechanical ventilation as part of their standard of care, as specified in the enrollment criteria; Device: CT Scan; Subjects will receive a CT scan as part of their standard of care, as specified in the enrollment criteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity for diagnosing lung pathology	The sensitivity and specificity of EIT for the detection and identification of different types of lung pathology will be assessed with clinical diagnosis aided by CT scan as the gold standard.	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Regional correlation with CT scan	The spatial correlation between the organs and lung pathology in the CT scan image in the plane of the electrodes and the EIT image will be computed.	One year

Collaborators and Investigators

• Sponsor: Colorado State University
• Collaborators: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
• Investigators: Principal Investigator: Jennifer L Mueller, Ph.D., Colorado State University

Publications and helpful links

General Publications

• Hamilton SJ, Mueller JL. Direct EIT reconstructions of complex admittivities on a chest-shaped domain in 2-D. IEEE Trans Med Imaging. 2013 Apr;32(4):757-69. doi: 10.1109/TMI.2012.2237389. Epub 2013 Jan 9.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: June 10, 2014
• First Submitted That Met QC Criteria: September 3, 2014
• First Posted (Estimate): September 5, 2014

Study Record Updates

• Last Update Posted (Estimate): February 1, 2017
• Last Update Submitted That Met QC Criteria: January 30, 2017
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Electrical impedance tomography; lung imaging
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Wounds and Injuries; Infant, Newborn, Diseases; Pleural Diseases; Lung Injury; Infant, Premature, Diseases; Wounds, Nonpenetrating; Pneumothorax; Pulmonary Atelectasis; Emphysema; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Pulmonary Edema; Pleural Effusion; Contusions
• Other Study ID Numbers: 13-4656H; 1R21EB016869-01A1 (U.S. NIH Grant/Contract)