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No volunteers were enrolled, study was closed
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| Name | Class |
|---|---|
| Vanderbilt University Medical Center | OTHER |
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The investigators will test whether breathing through an inspiratory resistance device will improve the ability to be upright and decrease blood pressure drops on standing in patients with orthostatic hypotension.
Orthostatic hypotension is commonly described, especially in an elderly population. Using data from a national hospital inpatient database, Shibao et al. have reported that the annual hospitalization rate for orthostatic hypotension was 233 per 100000 among patients older than 75 years. Orthostatic hypotension is associated with an increased risk of falls, increased risk of coronary heart disease and mortality.
Orthostatic hypotension is defined as a fall in systolic blood pressure of at least 20 mmHg within 3 minutes upon standing 3. Patients with orthostatic hypotension commonly experience lightheadedness or syncope. In normal individuals, changes in posture do not results in significant changes in blood pressure due to physiological compensation for the gravity-mediated pooling of blood in the lower limbs with upright posture. Unfortunately, in patients with impairments of the autonomic nervous system, one or more of these adaptive mechanisms fail, and an orthostatic fall in blood pressure results.
In this pilot study, we will test the hypothesis that breathing through an inspiratory resistance device will improve orthostatic tolerance and reduce orthostatic hypotension in patients with neurogenic orthostatic hypotension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ITD breathing device | Experimental | Breathing through the Res-Q-Gard ITD device from Advanced Circulatory Systems Inc. |
|
| Sham Device | Sham Comparator | Breathing device similar to active Res-Q-Gard device but with one-way resistance valve removed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inspiratory Threshold Device (Res-Q-Gard ITD) | Device | Patient will breathe through this device attached to a mouthpiece during assessment of orthostatic tolerance. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Magnitude of drop in Systolic Blood Pressure during head-up tilt | 1 min |
| Measure | Description | Time Frame |
|---|---|---|
| "Standing Time" tolerated with systolic blood pressure above 70 mmHg | 10 min (max) | |
| Symptom rating | 10 min (max) | |
| Hemodynamics (non-invasive) |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Satish R Raj, MD MSCI | Vanderbilt University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232-2195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17334239 | Background | Convertino VA, Ryan KL, Rickards CA, Cooke WH, Idris AH, Metzger A, Holcomb JB, Adams BD, Lurie KG. Inspiratory resistance maintains arterial pressure during central hypovolemia: implications for treatment of patients with severe hemorrhage. Crit Care Med. 2007 Apr;35(4):1145-52. doi: 10.1097/01.CCM.0000259464.83188.2C. | |
| 15864634 |
| Label | URL |
|---|---|
| Vanderbilt Autonomic Dysfunction Center Website | View source |
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| ID | Term |
|---|---|
| D007024 | Hypotension, Orthostatic |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Sham Inspiratory Threshold Device | Device | Breathing through device similar to active device but with the one-way threshold valve removed. |
|
|
| 10 min |
| 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. |
| 17976425 | Background | Shibao C, Grijalva CG, Raj SR, Biaggioni I, Griffin MR. Orthostatic hypotension-related hospitalizations in the United States. Am J Med. 2007 Nov;120(11):975-80. doi: 10.1016/j.amjmed.2007.05.009. |
| D007022 | Hypotension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |