Electrical Impedance Imaging of Patients on Mechanical Ventilation

NCT ID: NCT02232841

Last Updated: 2017-02-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-08-31

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.

Conditions

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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

Mechanical Ventilation

Intervention Type: DEVICE

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

CT Scan

Intervention Type: DEVICE

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

Interventions

Mechanical Ventilation

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

Intervention Type: DEVICE

CT Scan

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role: collaborator

Colorado State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer L Mueller, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Colorado State University

Locations

Medical Center of the Rockies

Loveland, Colorado, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 23314771 (View on PubMed)

Other Identifiers

1R21EB016869-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13-4656H

Identifier Type: -

Identifier Source: org_study_id