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

ARDS Clinical Trial

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)

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

• Acute Lung Injury
• Acute Lung Injury (ALI)
• ARDS
• Lung Injury
• Respiratory Distress Syndrome, Adult

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