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This study is being done to further the investigators' knowledge of the EIT system and to see if measures between two non-invasive ventilation systems routinely used clinically are equivalent.
Mechanical ventilation is life-saving technology but it can also inadvertently induce lung injury and increase morbidity and mortality. There currently is not an easy method of assessing the impact ventilator settings have on the degree of lung inflation. Computed tomography (CT), the gold standard for visually monitoring lung function, can provide detailed regional information of the lung. Unfortunately, it necessitates moving critically ill patients to a special diagnostic room and involves exposure to radiation like an X-ray.
A technique introduced in the 1980's, electrical impedance tomography (EIT), can non-invasively provide similar monitoring of lung function, and without the exposure to radiation. This imaging technique applies small alternating currents of electricity to surface electrodes to construct cross-sectional images of the lung.
Over that past several decades EIT has moved from the research lab to commercially available devices that are used at the bedside. EIT has also been applied to study the effects of various devices used to provide non-invasive ventilation. EIT may prove useful to optimally adjust non-invasive ventilation settings to improve ventilation and oxygenation. One such EIT system is manufactured by Draeger Medical. It is available in Europe and Canada but is not yet FDA approved for use in the United States.
This study is being done with healthy volunteers to further the investigators' knowledge of the EIT system and to see if measures between two non-invasive ventilation systems routinely used clinically are equivalent.
As this is a preliminary study looking at the EIT system vs 2 other devices, outcomes measures may be modified as the study progresses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Respironics V-60, then Draeger V500 | Active Comparator | Testing by applying noninvasive positive pressure ventilation (NPPV) via two different bilevel positive airway pressure (BiPAP) devices . Arm one applies the Respironics V-60, then the Drager V-500. |
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| Draeger V500, then Respironics V-60 | Active Comparator | Testing by applying noninvasive positive pressure ventilation (NPPV) via two different bilevel positive airway pressure (BiPAP) devices . Arm two applies the Drager V-500, then the Respironics V-60. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| noninvasive positive pressure ventilation | Device | Application of various levels of positive pressure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Global Tidal Variation (TID) | TID is the distribution of ventilation for a breath averaged over a defined section, the entire lung. TID is analogous to the tidal volume. Baseline is defined to be 100% and other measures are in comparison to baseline (eg, a value of 102 represents a 2% increase from baseline). | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Regional Tidal Variation: Dorsal | Distribution of ventilation for a breath averaged over a defined section, the dorsal lung regions. Reflects the percent of tidal volume distributed to that area. | 1 day |
| Regional Tidal Variation: Ventral |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carl Haas, MLS | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
All volunteers were screened for any contraindication to applying the electrical impedance tomography device (pacemaker, etc) before signing an informed consent document. No volunteer had such contraindications and all were successfully studied.
Volunteers were solicited via word of mouth from the medical staff and the respiratory therapy staff at our university hospital. Enrollment occurred from February 1, 2018 through March 27, 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Device 1, Then Device 2 | Testing by applying noninvasive positive pressure ventilation (NPPV) via two different bilevel positive airway pressure (BiPAP) devices: Respironics V-60 (Device 1) and Drager V-500 (Device 2) in a crossover study Device 1 is a continuous high flow, blower type of generator. |
| FG001 | Device 2, Then Device 1 | Testing by applying noninvasive positive pressure ventilation (NPPV) via two different bilevel positive airway pressure (BiPAP) devices: Respironics V-60 (Device 1) and Drager V-500 (Device 2) in a crossover study Device 2 is a critical care ventilator that has a specific NPPV mode. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Device 1, Then Device 2 | Testing by applying noninvasive positive pressure ventilation via two different bilevel positive airway pressure (BiPAP) devices: Respironics V-60 (Device 1) and Drager V-500 (Device 2) Device 1 is a continuous high flow, blower type of generator. |
| BG001 | Device 2, Then Device 1 |
| 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 | Global Tidal Variation (TID) | TID is the distribution of ventilation for a breath averaged over a defined section, the entire lung. TID is analogous to the tidal volume. Baseline is defined to be 100% and other measures are in comparison to baseline (eg, a value of 102 represents a 2% increase from baseline). | Posted | Mean | Standard Deviation | percentage of baseline | 1 day |
|
During study period (~90-120 minutes)
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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 | Volunteer | Testing by applying noninvasive positive pressure ventilation via two different bilevel positive airway pressure (BiPAP) devices: Respironics V-60 and Drager V-500. Respironics V-60: Continuous high flow, blower type of generator. Drager V-500: Critical care ventilator that has a specific NPPV mode. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carl Haas | University of Michigan Health System | 734-936-5234 | chaas@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 11, 2019 | Mar 18, 2019 | Prot_SAP_000.pdf |
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Distribution of ventilation for a breath averaged over a defined section, the ventral lung regions. Reflects the percent of tidal volume distributed to that area.
| 1 day |
| Global Change in End-expiratory Lung Impedance (EELI) | EELI is the impedance at the end of tidal variation, or end-expiration. EELI reflects the end-expiratory lung volume (EELV); thus an increase in EELI represents and increase in lung volume. The change in EELI that the electrical impedance tomography (EIT) device (Pulmovista, Drager) provides is the percent difference between the EELI of a given period and the EELI during a baseline or reference period. Positive or negative percent change suggests an increase or decrease in EELI and presumably EELV by a similar percentage. The baseline measurements used here were taken breathing air and no pressures applied, while the other measurements were taken with varying levels of pressure applied. By definition, baseline is assigned the value of 0%, by the EIT device. While it would be helpful to have the actual numbers for the baseline impedance values, this data was not provided by the EIT device. | 1 day |
| Regional Change in EELI: Dorsal | EELI is the impedance at the end of tidal variation, or end-expiration. EELI reflects the end-expiratory lung volume (EELV); thus an increase in EELI represents and increase in lung volume. The change in EELI that the electrical impedance tomography (EIT) device (Pulmovista, Drager) provides is the percent difference between the EELI of a given period and the EELI during a baseline or reference period. Positive or negative percent change suggests an increase or decrease in EELI and presumably EELV by a similar percentage. The baseline measurements used here were taken breathing air and no pressures applied, while the other measurements were taken with varying levels of pressure applied. By definition, baseline is assigned the value of 0%, by the EIT device. While it would be helpful to have the actual numbers for the baseline impedance values, this data was not provided by the EIT device | 1 day |
| Regional Change in EELI: Ventral | EELI is the impedance at the end of tidal variation, or end-expiration. EELI reflects the end-expiratory lung volume (EELV); thus an increase in EELI represents and increase in lung volume. The change in EELI that the electrical impedance tomography (EIT) device (Pulmovista, Drager) provides is the percent difference between the EELI of a given period and the EELI during a baseline or reference period. Positive or negative percent change suggests an increase or decrease in EELI and presumably EELV by a similar percentage. The baseline measurements used here were taken breathing air and no pressures applied, while the other measurements were taken with varying levels of pressure applied. By definition, baseline is assigned the value of 0%, by the EIT device. While it would be helpful to have the actual numbers for the baseline impedance values, this data was not provided by the EIT device | 1 day |
Testing by applying noninvasive positive pressure ventilation via two different bilevel positive airway pressure (BiPAP) devices: Respironics V-60 (Device 1) and Drager V-500 (Device 2). Device 2 is a critical care ventilator that has a specific NPPV mode. |
| BG002 | Total | Total of all reporting groups |
| 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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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| Secondary | Regional Tidal Variation: Dorsal | Distribution of ventilation for a breath averaged over a defined section, the dorsal lung regions. Reflects the percent of tidal volume distributed to that area. | Posted | Mean | Standard Deviation | percentage of global TID | 1 day |
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| Secondary | Regional Tidal Variation: Ventral | Distribution of ventilation for a breath averaged over a defined section, the ventral lung regions. Reflects the percent of tidal volume distributed to that area. | Posted | Mean | Standard Deviation | percentage of global TID | 1 day |
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| Secondary | Global Change in End-expiratory Lung Impedance (EELI) | EELI is the impedance at the end of tidal variation, or end-expiration. EELI reflects the end-expiratory lung volume (EELV); thus an increase in EELI represents and increase in lung volume. The change in EELI that the electrical impedance tomography (EIT) device (Pulmovista, Drager) provides is the percent difference between the EELI of a given period and the EELI during a baseline or reference period. Positive or negative percent change suggests an increase or decrease in EELI and presumably EELV by a similar percentage. The baseline measurements used here were taken breathing air and no pressures applied, while the other measurements were taken with varying levels of pressure applied. By definition, baseline is assigned the value of 0%, by the EIT device. While it would be helpful to have the actual numbers for the baseline impedance values, this data was not provided by the EIT device. | Because one subject's EELI data did not record properly on device 2, that subject's data was excluded from analysis for both arms. | Posted | Mean | Standard Deviation | percentage change from baseline | 1 day |
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| Secondary | Regional Change in EELI: Dorsal | EELI is the impedance at the end of tidal variation, or end-expiration. EELI reflects the end-expiratory lung volume (EELV); thus an increase in EELI represents and increase in lung volume. The change in EELI that the electrical impedance tomography (EIT) device (Pulmovista, Drager) provides is the percent difference between the EELI of a given period and the EELI during a baseline or reference period. Positive or negative percent change suggests an increase or decrease in EELI and presumably EELV by a similar percentage. The baseline measurements used here were taken breathing air and no pressures applied, while the other measurements were taken with varying levels of pressure applied. By definition, baseline is assigned the value of 0%, by the EIT device. While it would be helpful to have the actual numbers for the baseline impedance values, this data was not provided by the EIT device | Because one subject's EELI data did not record properly on device 2, that subject's data was excluded from analysis for both arms. | Posted | Mean | Standard Deviation | percentage change from baseline | 1 day |
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| Secondary | Regional Change in EELI: Ventral | EELI is the impedance at the end of tidal variation, or end-expiration. EELI reflects the end-expiratory lung volume (EELV); thus an increase in EELI represents and increase in lung volume. The change in EELI that the electrical impedance tomography (EIT) device (Pulmovista, Drager) provides is the percent difference between the EELI of a given period and the EELI during a baseline or reference period. Positive or negative percent change suggests an increase or decrease in EELI and presumably EELV by a similar percentage. The baseline measurements used here were taken breathing air and no pressures applied, while the other measurements were taken with varying levels of pressure applied. By definition, baseline is assigned the value of 0%, by the EIT device. While it would be helpful to have the actual numbers for the baseline impedance values, this data was not provided by the EIT device | Because one subject's EELI data did not record properly on device 2, that subject's data was excluded from analysis for both arms. | Posted | Mean | Standard Deviation | percentage change from baseline | 1 day |
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| 20 |
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| PS 5, CPAP 5 |
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| PS 5, CPAP 10 |
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| PS 5, CPAP 5 |
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| PS 5, CPAP 10 |
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| PS 5, CPAP 5 |
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| PS 5, CPAP 10 |
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| PS 5, CPAP 5 |
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| PS 5, CPAP 10 |
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| PS 5, CPAP 5 |
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| PS 5, CPAP 10 |
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