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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH-11-1-0542 | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
|---|---|
| U.S. Army Medical Research and Development Command | FED |
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The purpose of this study is to demonstrate proof of clinical concept that application of the Intrathoracic Pressure Regulator (ITPR) will result in an increase in Cerebral Perfusion Pressure (CPP) and a decrease in Intracranial Perfusion Pressure (ICP) in patients with head injury and elevated ICP, and to determine the optimal ventilation tidal volume (TV).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device |
|
| Group B | Active Comparator | tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device |
|
| Group C | Active Comparator | tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device |
|
| Group D | Active Comparator | tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| -7 cm H2O ITPR | Device | Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations. |
| Measure | Description | Time Frame |
|---|---|---|
| Intracranial Pressure (ICP) | Change in ICP from baseline will be compared with the ICP during 15 minutes of ITPR use. | 15 minutes after device is activated |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral Perfusion Pressure (CPP) | Measurement of the difference between baseline CPP and CPP at 15 minutes | 15 minutes after device activation |
| Lung Compliance | Change in lung compliance following each ITPR treatment compared to baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A | no device (washout) with tidal volume setting of 6ml/kg for 20 minutes, then 6ml/kg with the -7cm H2O ITPR as first device for 15 minutes, then tidal volume increased to 8ml/kg with the -7cm H2O ITPR for 15 minutes, then no device with 8ml/kg for 20 minutes, then 8ml/kg with -12cm H2O ITPR for 15 minutes, then 6ml/kg with -12cm H2O ITPR for 15 minutes, then no device with 6ml/kg. -7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations. |
| FG001 | Group B | no device (washout) with tidal volume setting of 8ml/kg for 20 minutes, then 8ml/kg with the -7cm H2O ITPR as first device for 15 minutes, then tidal volume decreased to 6ml/kg with the -7cm H2O ITPR for 15 minutes, then no device with 6ml/kg for 20 minutes, then 6ml/kg with -12cm H2O ITPR for 15 minutes, then 8ml/kg with -12cm H2O ITPR for 15 minutes, then no device with 8ml/kg. -7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations. |
| FG002 | Group C | no device (washout) with tidal volume setting of 6ml/kg for 20 minutes, then 6ml/kg with the -12cm H2O ITPR as first device for 15 minutes, then tidal volume increased to 8ml/kg with the -12cm H2O ITPR for 15 minutes, then no device with 8ml/kg for 20 minutes, then 8ml/kg with -7cm H2O ITPR for 15 minutes, then 6ml/kg with -7cm H2O ITPR for 15 minutes, then no device with 6ml/kg. -12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations. |
| FG003 | Group D | no device (washout) with tidal volume setting of 8ml/kg for 20 minutes, then 8ml/kg with the -12cm H2O ITPR as first device for 15 minutes, then tidal volume decreased to 6ml/kg with the -12cm H2O ITPR for 15 minutes, then no device with 6ml/kg for 20 minutes, then 6ml/kg with -7cm H2O ITPR for 15 minutes, then 8ml/kg with -7cm H2O ITPR for 15 minutes, then no device with 8ml/kg. -12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A | tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device -7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Number |
| 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 | Intracranial Pressure (ICP) | Change in ICP from baseline will be compared with the ICP during 15 minutes of ITPR use. | Posted | Number | mmHg | 15 minutes after device is activated |
|
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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 | Group A | tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device -7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Clinical Research Associate | Advanced Circulatory | 651.403.5600 | nburkhart@advancedcirculatory.com |
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| ID | Term |
|---|---|
| D006259 | Craniocerebral Trauma |
| D000070642 | Brain Injuries, Traumatic |
| D006501 | Hepatic Encephalopathy |
| D006849 | Hydrocephalus |
| D020300 | Intracranial Hemorrhages |
| ID | Term |
|---|---|
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
| D001930 | Brain Injuries |
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|
|
| -12cm H2O ITPR | Device | Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations. |
|
|
| baseline and immediately after device removal |
| Arterial Blood Gases (PaCO2) | Arterial blood gases will be collected. | 15 minutes after device activation |
| BG001 | Group B | tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device -7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations. |
| BG002 | Group C | tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device -12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations. |
| BG003 | Group D | tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device -12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations. |
| BG004 | Total | Total of all reporting groups |
| participants |
|
| Gender | Number | participants |
|
| OG002 | Group C | tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device -12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations. |
| OG003 | Group D | tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device -12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations. |
|
|
| Secondary | Cerebral Perfusion Pressure (CPP) | Measurement of the difference between baseline CPP and CPP at 15 minutes | Posted | Number | mmHg | 15 minutes after device activation |
|
|
|
| Secondary | Lung Compliance | Change in lung compliance following each ITPR treatment compared to baseline. | Posted | Number | ml/cmH2O | baseline and immediately after device removal |
|
|
|
| Secondary | Arterial Blood Gases (PaCO2) | Arterial blood gases will be collected. | Posted | Number | mmHg | 15 minutes after device activation |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Group B | tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device -7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations. | 0 | 0 | 0 | 0 |
| EG002 | Group C | tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device -12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations. | 0 | 0 | 0 | 0 |
| EG003 | Group D | tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device -12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations. | 0 | 0 | 0 | 0 |
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001928 | Brain Diseases, Metabolic |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| 6ml/kg; -12cmH2O |
|
| Title | Measurements |
|---|---|
|
| 6ml/kg; -12cmH2O |
|
| Title | Measurements |
|---|---|
|
| 6ml/kg; -12cmH2O |
|