Electrical Impedance Imaging of Patients on Mechanical Ventilation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pneumothorax, Pulmonary Contusion, Pleural Effusion, Pulmonary Edema, Atelectasis, Hyperinflation, Emphysema, Acute Respiratory Distress Syndrome

Intervention / Treatment
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* Device: Mechanical Ventilation
* Device: CT Scan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mechanical ventilation<br>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<br>* Subjects will receive mechanical ventilation as part of their standard of care, as specified in the enrollment criteria<br>Device: CT Scan<br>* Subjects will receive a CT scan as part of their standard of care, as specified in the enrollment criteria<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrical impedance tomography, lung imaging