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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01272882
Other study ID # CCC#30067
Secondary ID DDD# 600788
Status Completed
Phase N/A
First received January 3, 2011
Last updated December 4, 2012
Start date May 2010
Est. completion date March 2011

Study information

Verified date December 2012
Source Christiana Care Health Services
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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 intensive care unit (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.


Description:

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 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 day shift (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.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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. Partial pressure of arterial oxygen (PaO2) / Fraction of inspired oxygen (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.

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Device:
Electrical Impedance Tomography monitoring
Chest belt with 16 electrodes connected to the EIT device

Locations

Country Name City State
United States Christiana Hospital Newark Delaware

Sponsors (1)

Lead Sponsor Collaborator
Christiana Care Health Services

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility of EIT Monitoring in This Population of ARDS/ALI Patients Feasibility for the purposes of our study was the ability to apply the device to a diverse population of ARDS/ALI patients and obtain EIT data from the device. At the start of monitoring once the patient was consented and enrolled. No
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