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Electrical Impedance Imaging of Patients on Mechanical Ventilation

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02232841
Enrollment
2
Registered
2014-09-05
Start date
2014-09-30
Completion date
2016-08-31
Last updated
2017-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Electrical impedance tomography, lung imaging

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.

Interventions

DEVICEMechanical Ventilation

Subjects will receive mechanical ventilation as part of their standard of care, as specified in the enrollment criteria

DEVICECT Scan

Subjects will receive a CT scan as part of their standard of care, as specified in the enrollment criteria

Sponsors

National Institute for Biomedical Imaging and Bioengineering (NIBIB)
CollaboratorNIH
Colorado State University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity and specificity for diagnosing lung pathologyOne yearThe 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.

Secondary

MeasureTime frameDescription
Regional correlation with CT scanOne yearThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026