Electrical Impedance Imaging of Patients on Mechanical Ventilation

Completed

• Conditions: Hyperinflation; Acute Respiratory Distress Syndrome; Pneumothorax; Pulmonary Contusion; Pleural Effusion; Pulmonary Edema; Emphysema; Atelectasis
• Interventions: Device: Mechanical Ventilation; Device: CT Scan

• Registration Number: NCT02232841
• Lead Sponsor: Colorado State University

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.

Study Timeline

• Study First Submitted: 2014-06-10
• Study Start: 2014-09
• Study First Submitted QC: 2014-09-03
• Study First Posted: 2014-09-05
• Status Verified: 2016-07
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mechanical ventilation	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	CT Scan	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

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity for diagnosing lung pathology	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 Outcome Measures

Name	Time	Method
Regional correlation with CT scan	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.

Trial Locations

Locations (1)

Medical Center of the Rockies; 🇺🇸 Loveland, Colorado, United States