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| ID | Type | Description | Link |
|---|---|---|---|
| 5R44NS054372 | U.S. NIH Grant/Contract | View source |
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Enrollment was slower than anticipated.
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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The purpose of the study is to evaluate the physiological response to application of the Intrathoracic Pressure Regulator (ITPR) in patients with compromised cerebral circulation. The study will evaluate the physiological response to intrathoracic pressure regulation (IPR) therapy in hemodynamically stable patients with compromised cerebral circulation who are on ventilatory support.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ITPR | Experimental | Use of the ITPR for 120 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ITPR | Device | Single use noninvasive device that is connected to a vacuum source and a means to deliver a positive pressure breath. The device generates negative pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure between the periods of positive pressure ventilations. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Cerebral Perfusion Pressure (CPP) | Change from average baseline CPP compared with the average CPP during use of the ITPR. | During 120 minutes of device use |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Systolic Blood Pressure (SBP) | Measure change in systolic blood pressure average during baseline and 15 minutes following removal of the ITPR | baseline to15 minutes following device use |
| Change From Baseline in PaCO2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver | Denver | Colorado | United States | |||
| Baltimore |
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| ID | Title | Description |
|---|---|---|
| FG000 | ITPR | Use of the ITPR for 120 minutes. ITPR: Single use noninvasive device that is connected to a vacuum source and a means to deliver a positive pressure breath. The device generates negative pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure between the periods of positive pressure ventilations. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | ITPR | Use of the ITPR for 120 minutes. ITPR: Single use noninvasive device that is connected to a vacuum source and a means to deliver a positive pressure breath. The device generates negative pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure between the 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, Continuous | Mean |
| 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 | Change From Baseline in Cerebral Perfusion Pressure (CPP) | Change from average baseline CPP compared with the average CPP during use of the ITPR. | Posted | Mean | Standard Deviation | mmHg | During 120 minutes of device use |
|
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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 | ITPR | Use of the ITPR for 120 minutes. ITPR: Single use noninvasive device that is connected to a vacuum source and a means to deliver a positive pressure breath. The device generates negative pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure between the periods of positive pressure ventilations. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Desaturation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Patient had SpO2 desaturation to 89% likely the result of a brief ventilator disconnect |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Clinical Research Associate | Advanced Circulatory | 651.403.5606 | nburkhart@zoll.com |
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| ID | Term |
|---|---|
| D006259 | Craniocerebral Trauma |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
| D001930 | Brain Injuries |
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PaCO2 will be collected during baseline and 15 minutes after device activation and change will be evaluated.
| baseline and 15 minutes after device activation |
| Change From Baseline in Diastolic Blood Pressure (DBP) | Measure change in diastolic blood pressure average during baseline and 15 minutes following removal of the ITPR | baseline to 15 minutes following device use |
| Change From Baseline in Mean Arterial Pressure (MAP) | Measure change in mean arterial pressure average during baseline and 15 minutes following removal of the ITPR | baseline to 15 minutes following device use |
| Change From Baseline in Heart Rate (HR) | Measure change in heart rate average during baseline and 15 minutes following removal of the ITPR | baseline to 15 minutes following device use |
| Change From Baseline in Pulse Pressure (PP) | Measure change in pulse pressure average during baseline and 15 minutes following removal of the ITPR | baseline to 15 minutes following device use |
| Change From Baseline in End-tidal Carbon Dioxide (EtCO2) | Measure change in EtCO2 average during baseline and 15 minutes following removal of the ITPR | baseline to 15 minutes following device use |
| Change From Baseline in Oxygen Saturation (SpO2) | Measure change in SpO2 average during baseline and 15 minutes following removal of the ITPR | basseline to 15 minutes following device use |
| Baltimore |
| Maryland |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) | Measure change in systolic blood pressure average during baseline and 15 minutes following removal of the ITPR | Posted | Mean | Standard Deviation | mmHg | baseline to15 minutes following device use |
|
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|
| Secondary | Change From Baseline in PaCO2 | PaCO2 will be collected during baseline and 15 minutes after device activation and change will be evaluated. | PaCO2 values for comparison were not available for two subjects | Posted | Mean | Standard Deviation | mmHg | baseline and 15 minutes after device activation |
|
|
|
| Secondary | Change From Baseline in Diastolic Blood Pressure (DBP) | Measure change in diastolic blood pressure average during baseline and 15 minutes following removal of the ITPR | Posted | Mean | Standard Deviation | mmHg | baseline to 15 minutes following device use |
|
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| Secondary | Change From Baseline in Mean Arterial Pressure (MAP) | Measure change in mean arterial pressure average during baseline and 15 minutes following removal of the ITPR | Posted | Mean | Standard Deviation | mmHg | baseline to 15 minutes following device use |
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| Secondary | Change From Baseline in Heart Rate (HR) | Measure change in heart rate average during baseline and 15 minutes following removal of the ITPR | Posted | Mean | Standard Deviation | beats/min | baseline to 15 minutes following device use |
|
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| Secondary | Change From Baseline in Pulse Pressure (PP) | Measure change in pulse pressure average during baseline and 15 minutes following removal of the ITPR | Posted | Mean | Standard Deviation | mmHg | baseline to 15 minutes following device use |
|
|
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| Secondary | Change From Baseline in End-tidal Carbon Dioxide (EtCO2) | Measure change in EtCO2 average during baseline and 15 minutes following removal of the ITPR | Posted | Mean | Standard Deviation | mmHg | baseline to 15 minutes following device use |
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| Secondary | Change From Baseline in Oxygen Saturation (SpO2) | Measure change in SpO2 average during baseline and 15 minutes following removal of the ITPR | Posted | Mean | Standard Deviation | percentage of saturation | basseline to 15 minutes following device use |
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| 0 |
| 9 |
| 3 |
| 9 |
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| Device deficiency | Product Issues | Systematic Assessment | device made a strange noise when it was turned on |
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| Increased ICP | Vascular disorders | Systematic Assessment | subject's ICP increased by >10mmHg without a concurrent rise in CerPP at the end of the run-in period before device was placed |
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |