Electrical Impedance Tomography (EIT) Monitoring in Adults With ALI or ARDS
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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 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.
| Condition | Intervention |
|---|---|
|
Acute Lung Injury (ALI) ARDS |
Device: Electrical Impedance Tomography monitoring |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Single Blind (Caregiver) Primary Purpose: Basic Science |
| 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) |
- Feasibility of EIT Monitoring in This Population of ARDS/ALI Patients [ Time Frame: At the start of monitoring once the patient was consented and enrolled. ] [ Designated as safety issue: No ]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.
| Enrollment: | 13 |
| Study Start Date: | May 2010 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Adults with ARDS or ALI
Adults with PaO2/FiO2 ratio less than 300. Consented patients will be placed on EIT monitor.
|
Device: Electrical Impedance Tomography monitoring
Chest belt with 16 electrodes connected to the EIT device
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, Delaware | |
| Christiana Hospital | |
| Newark, Delaware, United States, 19718 | |
| Principal Investigator: | John S Emberger, BS | Christiana Care Health Services |
| Principal Investigator: | Vinay Maheshwari, MD | Christiana Care Health Services |
| Principal Investigator: | Joel M Brown, BS | Christiana Care Health Services |
More Information
No publications provided
| Responsible Party: | Christiana Care Health Services |
| ClinicalTrials.gov Identifier: | NCT01272882 History of Changes |
| Other Study ID Numbers: | CCC#30067, DDD# 600788 |
| Study First Received: | January 3, 2011 |
| Results First Received: | October 31, 2012 |
| Last Updated: | December 4, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Lung Injury Lung Diseases Respiratory Tract Diseases |
Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Thoracic Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on May 19, 2013