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| ID | Type | Description | Link |
|---|---|---|---|
| Contract W81XWH-04-C-0022 |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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The purpose of this study is to determine if the impedance threshold device (ITD) attached to a facemask can increase blood pressure in patients who present to the emergency department with hypotension secondary to hypovolemia. The cause of hypovolemia could be blood loss, sepsis, or dehydration.
The study is designed to test the hypothesis that use of the ITD will result in a rapid rise in blood pressure secondary to an increase in cardiac output. Either an active or sham ITD will be applied to hypotensive patients when initially presented to the emergency department with a systolic blood pressure of <95mmHg. The main endpoint of this study will be the rise in blood pressure over the first 10 minutes of use. Based upon pre-clinical studies as well as clinical studies performed to date, we hypothesize that use of the active ITD will result in a more rapid and higher blood pressure than the sham ITD. Multiple additional clinical parameters will also be compared between the two groups of patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham ITD | Sham Comparator | sham Impedance Threshold Device |
|
| active ITD | Active Comparator | active impedance threshold device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Impedance Threshold Device | Device | Active impedance threshold device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rise in Systolic Blood Pressure Over the First 10 Minutes of Use Compared to Baseline | every 2 minutes during 10 minutes of device use |
| Measure | Description | Time Frame |
|---|---|---|
| Quantity of Fluid Administration | during 10 minutes of device use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keith Lurie, MD | Advanced Circulatory Systems | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hennepin County Medical Center | Minneapolis | Minnesota | 55404 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15828629 | Background | Convertino VA, Cooke WH, Lurie KG. Inspiratory resistance as a potential treatment for orthostatic intolerance and hemorrhagic shock. Aviat Space Environ Med. 2005 Apr;76(4):319-25. | |
| 15864634 | Background | Convertino VA, Ratliff DA, Crissey J, Doerr DF, Idris AH, Lurie KG. Effects of inspiratory impedance on hemodynamic responses to a squat-stand test in human volunteers: implications for treatment of orthostatic hypotension. Eur J Appl Physiol. 2005 Jul;94(4):392-9. doi: 10.1007/s00421-005-1344-1. Epub 2005 Apr 28. |
| Label | URL |
|---|---|
| Advanced Circulatory Systems, Inc. home page | View source |
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Patients were recruited from the emergency department based on age (18-85)and systolic blood pressure ≤95mmHg who were conscious and presumed to have hypotension due to hypoivolemia or relative hypovolemia (blood loss, dehydration, or sepsis).
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham ITD | sham Impedance Threshold Device |
| FG001 | Active ITD | active impedance threshold device |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sham ITD | sham Impedance Threshold Device |
| BG001 | Active ITD | active impedance threshold device |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Rise in Systolic Blood Pressure Over the First 10 Minutes of Use Compared to Baseline | Posted | Mean | Standard Deviation | mm Hg | every 2 minutes during 10 minutes of device use |
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|
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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 | Sham ITD | sham Impedance Threshold Device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nathan Burkhart | Advanced Circulatory | 651.403.5600 | nburkhart@advancedcirculatory.com |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| D020896 | Hypovolemia |
| D003681 | Dehydration |
| D018805 | Sepsis |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| sham ITD | Device | sham impedance threshold device |
|
| 15508665 | Background | Convertino VA, Ratliff DA, Ryan KL, Doerr DF, Ludwig DA, Muniz GW, Britton DL, Clah SD, Fernald KB, Ruiz AF, Lurie KG, Idris AH. Hemodynamics associated with breathing through an inspiratory impedance threshold device in human volunteers. Crit Care Med. 2004 Sep;32(9 Suppl):S381-6. doi: 10.1097/01.ccm.0000134348.69165.15. |
| 20634018 | Result | Smith SW, Parquette B, Lindstrom D, Metzger AK, Kopitzke J, Clinton J. An impedance threshold device increases blood pressure in hypotensive patients. J Emerg Med. 2011 Nov;41(5):549-58. doi: 10.1016/j.jemermed.2010.05.013. Epub 2010 Jul 15. |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| Secondary | Quantity of Fluid Administration | Posted | Mean | Standard Deviation | mL | during 10 minutes of device use |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Active ITD | active impedance threshold device | 0 | 24 | 0 | 24 |
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| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |