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| ID | Type | Description | Link |
|---|---|---|---|
| DDD# 600788 | Other Identifier | DDD# 600788 |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults with ARDS or ALI | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrical Impedance Tomography monitoring | Device | Chest belt with 16 electrodes connected to the EIT device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Patients will be included in this study if the following criteria have been met:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christiana Hospital | Newark | Delaware | 19718 | United States |
IPD data will not be shared
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No pre-assignment details to note.
Intensive care units
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | Patients successfully monitored with EIT | At the start of monitoring once the patient was consented and enrolled. |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Fulda | ChristianaCHS | 302-733-4260 | gfulda@christianacare.org |
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| ID | Term |
|---|---|
| D055371 | Acute Lung Injury |
| ID | Term |
|---|---|
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 13 |
| 0 |
| 13 |
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