Acute Lung Injury (ALI), ARDS
Conditions
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.
Interventions
Chest belt with 16 electrodes connected to the EIT device
Sponsors
Christiana Care Health Services
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of EIT Monitoring in This Population of ARDS/ALI Patients | At the start of monitoring once the patient was consented and enrolled. | 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. |
Countries
United States
Participant flow
Recruitment details
Intensive care units
Pre-assignment details
No pre-assignment details to note.
Participants by arm
| Arm | Count |
|---|---|
| Adults With ARDS or ALI Adults with PaO2/FiO2 ratio less than 300.
Electrical Impedance Tomography monitoring : Chest belt with 16 electrodes connected to the EIT device | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | Adults With ARDS or ALI |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Age, Continuous | 55 years STANDARD_DEVIATION 22 |
| Region of Enrollment United States | 13 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
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.
Time frame: At the start of monitoring once the patient was consented and enrolled.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adults With ARDS or ALI | Feasibility of EIT Monitoring in This Population of ARDS/ALI Patients | 13 Patients successfully monitored with EIT |