Electrical Impedance Imaging of Patients on Mechanical Ventilation

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02232841
• Other study ID #: 13-4656H
• Secondary ID: 1R21EB016869-01A
• Status: Completed
• Phase: N/A
• First received: June 10, 2014
• Last updated: January 30, 2017
• Start date: September 2014
• Est. completion date: August 2016

Study information

• Verified date: July 2016
• Source: Colorado State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Atelectasis
• Contusions
• Emphysema
• Hyperinflation
• Pleural Effusion
• Pneumothorax
• Pulmonary Atelectasis
• Pulmonary Contusion
• Pulmonary Edema
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• Mechanical Ventilation
Subjects will receive mechanical ventilation as part of their standard of care, as specified in the enrollment criteria
• CT Scan
Subjects will receive a CT scan as part of their standard of care, as specified in the enrollment criteria

Locations

Country	Name	City	State
United States	Medical Center of the Rockies	Loveland	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Colorado State University	National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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