Electrical Impedance Tomography (EIT) Monitoring in Adults With ALI or ARDS

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT01272882
First received: January 3, 2011
Last updated: December 4, 2012
Last verified: December 2012
  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)

Resource links provided by NLM:


Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • 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:

  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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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. 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01272882

Locations
United States, Delaware
Christiana Hospital
Newark, Delaware, United States, 19718
Sponsors and Collaborators
Christiana Care Health Services
Investigators
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
Wounds and Injuries
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries

ClinicalTrials.gov processed this record on August 28, 2014