Clinical trial NCT02232841: Electrical Impedance Imaging of Patients on Mechanical Ventilation
Official title: Pilot Study: Electrical Impedance Imaging of Patients on Mechanical Ventilation With Lung Pathology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumothorax
Pulmonary Contusion
Pleural Effusion
Pulmonary Edema
Atelectasis
Hyperinflation
Emphysema
Acute Respiratory Distress Syndrome
Keywords: Electrical impedance tomography
lung imaging
Lead sponsor: Colorado State University
Sponsor class: OTHER
Collaborators: name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
First posted: 2014-09-05
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity and specificity for diagnosing lung pathology
timeFrame: One year
Secondary outcomes:
measure: Regional correlation with CT scan
timeFrame: One year
Other outcomes:
Locations:
city: Loveland
country: United States
facility: Medical Center of the Rockies
state: Colorado
Study officials:
affiliation: Colorado State University
name: Jennifer L Mueller, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.