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

NCT ID: NCT01272882

Last Updated: 2017-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2011-03-31

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:

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.

Conditions

Acute Lung Injury (ALI); ARDS

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Adults with ARDS or ALI

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.

Group Type: EXPERIMENTAL

Electrical Impedance Tomography monitoring

Intervention Type: DEVICE

Chest belt with 16 electrodes connected to the EIT device

Interventions

Electrical Impedance Tomography monitoring

Chest belt with 16 electrodes connected to the EIT device

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Christiana Care Health Services

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John S Emberger, BS

Role: PRINCIPAL_INVESTIGATOR

Christiana Care Health Services

Vinay Maheshwari, MD

Role: PRINCIPAL_INVESTIGATOR

Christiana Care Health Services

Joel M Brown, BS

Role: PRINCIPAL_INVESTIGATOR

Christiana Care Health Services

Locations

Christiana Hospital

Newark, Delaware, United States

Countries

United States

Other Identifiers

DDD# 600788

Identifier Type: OTHER

Identifier Source: secondary_id

CCC#30067

Identifier Type: -

Identifier Source: org_study_id