Electrical Impedance Imaging of Patients on Mechanical Ventilation

NCT02232841 | Completed DMC

• 2 other identifiers: 13-4656H1R21EB016869-01A1
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Electrical impedance tomography; lung imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Regional correlation with CT scan

  One year

Study Arms (1)

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

Device: Mechanical Ventilation; Device: CT Scan

Interventions

Mechanical Ventilation DEVICE

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

Mechanical ventilation

CT Scan DEVICE

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

Mechanical ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Colorado State University: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (1)

Medical Center of the Rockies

Loveland, Colorado, 80538, United States

Location

Related Publications (1)

• 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.

  PMID: 23314771 BACKGROUND

MeSH Terms

Conditions

Pneumothorax; Pleural Effusion; Pulmonary Edema; Pulmonary Atelectasis; Emphysema; Respiratory Distress Syndrome

Interventions

Respiration, Artificial; Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Lung Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Jennifer L Mueller, Ph.D.

  Colorado State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: September 5, 2014
• Study Start: September 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: February 1, 2017

Record last verified: 2016-07

Locations

US (1)