Electrical Impedance Tomography (EIT) Monitoring in Adults With ALI or ARDS
Primary Purpose
Acute Lung Injury (ALI), ARDS
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electrical Impedance Tomography monitoring
Sponsored by
About this trial
This is an interventional basic science trial for Acute Lung Injury (ALI)
Eligibility Criteria
Inclusion Criteria:
Patients will be included in this study if the following criteria have been met:
- Males and females > 18 years old (non-pregnant, non-lactating females).
- Partial pressure of arterial oxygen (PaO2) / Fraction of inspired oxygen (FiO2) ratio < 300 torr.
- Signed informed consent has been obtained.
Exclusion Criteria:
- Females who are pregnant or lactating.
- Patients with skin abrasions or wounds in the chest area.
- Patients receiving dialysis.
- Patients with pacemakers or paced EKG rhythms.
Sites / Locations
- Christiana Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Adults with ARDS or ALI
Arm Description
Adults with PaO2/FiO2 ratio less than 300. Consented patients will be placed on EIT monitor. The only intervention is the addition of Electrical Impedance Tomography monitoring using the Chest belt with 16 electrodes connected to the EIT device. No changes to standard patient care will occur other than collecting EIT monitor data.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01272882
First Posted
January 3, 2011
Last Updated
April 27, 2017
Sponsor
Christiana Care Health Services
1. Study Identification
Unique Protocol Identification Number
NCT01272882
Brief Title
Electrical Impedance Tomography (EIT) Monitoring in Adults With ALI or ARDS
Official Title
Electrical Impedance Tomography (EIT) Monitoring: A Pilot Comparison to Standard of Care Assessments in Adults With Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Christiana Care Health Services
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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:
EIT electrode chest band will be applied by trained respiratory care staff. Application includes elastic chest band with 16 electrodes.
EIT electrode chest band is connected to the EIT monitor which will be turned on and will monitor and store EIT data.
EIT monitoring will take place for 4 to 6 hours, during day shift (7am to 4pm)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury (ALI), ARDS
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adults with ARDS or ALI
Arm Type
Experimental
Arm Description
Adults with PaO2/FiO2 ratio less than 300. Consented patients will be placed on EIT monitor. The only intervention is the addition of Electrical Impedance Tomography monitoring using the Chest belt with 16 electrodes connected to the EIT device. No changes to standard patient care will occur other than collecting EIT monitor data.
Intervention Type
Device
Intervention Name(s)
Electrical Impedance Tomography monitoring
Intervention Description
Chest belt with 16 electrodes connected to the EIT device
Primary Outcome Measure Information:
Title
Feasibility of EIT Monitoring in This Population of ARDS/ALI Patients
Description
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.
Time Frame
At the start of monitoring once the patient was consented and enrolled.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients will be included in this study if the following criteria have been met:
Males and females > 18 years old (non-pregnant, non-lactating females).
Partial pressure of arterial oxygen (PaO2) / Fraction of inspired oxygen (FiO2) ratio < 300 torr.
Signed informed consent has been obtained.
Exclusion Criteria:
Females who are pregnant or lactating.
Patients with skin abrasions or wounds in the chest area.
Patients receiving dialysis.
Patients with pacemakers or paced EKG rhythms.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John S Emberger, BS
Organizational Affiliation
Christiana Care Health Services
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vinay Maheshwari, MD
Organizational Affiliation
Christiana Care Health Services
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joel M Brown, BS
Organizational Affiliation
Christiana Care Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD data will not be shared
Learn more about this trial
Electrical Impedance Tomography (EIT) Monitoring in Adults With ALI or ARDS
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