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Newark, Delaware 19718


Purpose:

Electrical impedance tomography (EIT) monitoring has been researched as a method to determine the spatial impedance distribution in a body cross section, but has yet to become an established clinical tool. EIT monitoring gives a dynamic, breath-to-breath measurement of both global and regional ventilation. Recently, there has been evidence that EIT monitoring has great potential to become a non-invasive bedside tool for assessment of regional lung ventilation without documented hazards. Potential applications include any adult patients in acute respiratory failure. Data collected from this research may contribute to improved patient safety outcomes. PURPOSE: The purpose of this pilot study is to examine the feasibility of using the EIT monitor in ICU setting on patients with acute respiratory failure and to compare the EIT monitor data to standard of care patient assessments. It is hypothesized that the EIT monitor, when applied to adults in acute respiratory failure, will correlate with conventional standard of care assessments for these patients.


Study summary:

INTRODUCTION: Electrical impedance tomography (EIT) monitoring has been researched as a method to determine the spatial impedance distribution in a body cross section, but has yet to become an established clinical tool. EIT monitoring gives a dynamic, breath-to-breath measurement of both global and regional ventilation. Recently, there has been evidence that EIT monitoring has great potential to become a non-invasive bedside tool for assessment of regional lung ventilation without documented hazards. Potential applications include any adult patients in acute respiratory failure. Data collected from this research may contribute to improved patient safety outcomes. PURPOSE: The purpose of this pilot study is to examine the feasibility of using the EIT monitor in ICU setting on patients with acute respiratory failure and to compare the EIT monitor data to standard of care patient assessments. It is hypothesized that the EIT monitor, when applied to adults in acute respiratory failure, will correlate with conventional standard of care assessments for these patients. METHOD: This pilot study design will consist of a prospective, blinded evaluation of the Draeger EIT monitor for patients with acute lung injury or acute respiratory distress syndrome. Once a patient has met the inclusion criteria and has signed informed consent: 1. EIT electrode chest band will be applied by trained respiratory care staff. Application includes elastic chest band with 16 electrodes. 2. EIT electrode chest band is connected to the EIT monitor which will be turned on and will monitor and store EIT data. 3. EIT monitoring will take place for 4 to 6 hours, during dayshift (7am to 4pm) 4. Patient's may be monitored on three separate days. No interventions, tests or modifications to the standard of care will occur to patients for this pilot study of EIT monitoring. Clinicians guiding the care of these patients will be blinded to the EIT data. The EIT chest band will be removed if transport of the patient is necessary or if care is needed in the area of the chest band.


Criteria:

Inclusion Criteria: Patients will be included in this study if the following criteria have been met: 1. Males and females > 18 years old (non−pregnant, non−lactating females). 2. PaO2/FiO2 ratio < 300 torr. 3. Signed informed consent has been obtained. Exclusion Criteria: 1. Females who are pregnant or lactating. 2. Patients with skin abrasions or wounds in the chest area. 3. Patients receiving dialysis. 4. Patients with pacemakers or paced EKG rhythms.


NCT ID:

NCT01272882


Primary Contact:

Principal Investigator
John S Emberger, BS
Christiana Care Health Services


Backup Contact:

N/A


Location Contact:

Newark, Delaware 19718
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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