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Completed

NCT Number: NCT02232841

Electrical Impedance Imaging of Patients on Mechanical Ventilation

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.

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Key information

Conditions

Pneumothorax Acute Respiratory Distress Syndrome Atelectasis Emphysema Hyperinflation Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pleural Diseases Pleural Effusion Pulmonary Atelectasis Pulmonary Contusion Pulmonary Edema Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Center of the Rockies

Loveland, Colorado, 80538, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mechanical ventilation

Device

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

CT Scan

Device

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

Primary outcomes

  1. Sensitivity and specificity for diagnosing lung pathology

    Time frame: One year

    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.

Secondary outcomes

  1. Regional correlation with CT scan

    Time frame: One year

    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.

Sponsors and collaborators

Lead sponsor

Colorado State University

Other

Collaborators

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 5, 2014
Registry last updated
Feb 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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