Clinical trial NCT01272882: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Lung Injury (ALI)
ARDS
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
First posted: 2011-01-10
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Feasibility of EIT Monitoring in This Population of ARDS/ALI Patients
timeFrame: At the start of monitoring once the patient was consented and enrolled.
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
Study officials:
affiliation: Christiana Care Health Services
name: John S Emberger, BS
role: PRINCIPAL_INVESTIGATOR
affiliation: Christiana Care Health Services
name: Vinay Maheshwari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Christiana Care Health Services
name: Joel M Brown, BS
role: PRINCIPAL_INVESTIGATOR
References: