Abdominal and Lower Extremity Compression During Tilt Table Testing in Adolescent POTS Patients
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Purpose
Postural orthostatic tachycardia syndrome (POTS) is a common cause of orthostatic intolerance in adolescents and adults. Compression stockings are commonly recommended as a treatment modality for POTS, but the effects of abdominal and lower extremity compression during tilt table testing have not been measured in adolescent patients. The aims of our study are to compare heart-rate changes and symptom onset during tilt table testing (a) with and without abdomen/lower extremity compression and (b) with abdominal compression only versus lower extremity compression only. During phase 1, 20 adolescents with POTS will undergo up to 10 minutes of tilt without compression (trial #1), a repeat study of up to 10 minutes with full compression (trial #2), and a third study without compression up to 10 minutes (trial #3). Compression will be performed using the non-inflatable Zoex anti-shock garment. During study phase 2, an additional 20 adolescent POTS patients will undergo up to 10 minutes of tilt without compression (trial #1), a repeat study of up to 10 minutes with abdominal compression only [n=10] or lower extremity compression only [n=10] (trial #2), and a third study repeated without compression up to 10 minutes (trial #3). To limit compression to the abdomen only, we will use the Zoex garment strap numbers 4 and 5 (thigh and abdomen) without straps 1-3 (lower extremities). For lower extremity-only compression, we will use Zoex garment straps 1-4 (lower extremity and thigh) without strap 5. Data collected will include mean and peak heart rates and timing of symptoms with each trial. A paired-samples t-test will be used to compare mean heart rates between trials for each study phase. Hazard analyses will be used to assess time-based endpoints.
| Condition | Intervention |
|---|---|
|
Postural Orthostatic Tachycardia Syndrome (POTS) Syncope |
Device: Zoex compression garment |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
- Heart-rate elevation [ Time Frame: Comparison between tilt table trials of up to 10 minutes duration without and with abdominal and/or lower extremity compression ] [ Designated as safety issue: No ]
- Symptom onset [ Time Frame: Comparison between tilt table trials of up to 10 minutes duration witout and with abdominal and/or lower extremity compression ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | February 2013 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Abdominal and lower extremity compression
Zoex compression garment during tilt testing (all straps)
|
Device: Zoex compression garment
5-strap compression of abdomen, thighs and legs
|
|
Experimental: abdominal compression only
Zoex compression garment use during tilt table testing (straps 4 and 5 fastened around thighs and abdomen)
|
Device: Zoex compression garment
5-strap compression of abdomen, thighs and legs
|
|
Experimental: Lower extremity compression only
Zoex compression garment use during tilt table testing (straps 1-4, lower extremity and thighs, fastened)
|
Device: Zoex compression garment
5-strap compression of abdomen, thighs and legs
|
Eligibility| Ages Eligible for Study: | 12 Years to 19 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 12-19 years
- POTS diagnosis
- English speaking -
Exclusion Criteria:
- Somatic, cognitive, or psychiatric disorder that could prevent safe tilt table testing
- Medications that cannot be stopped/held safely for the procedure, but can cause or exacerbate orthostatic intolerance -
Contacts and Locations| United States, Ohio | |
| Nationwide Children's Hospital, neurology outpatient clinic | Recruiting |
| Columbus, Ohio, United States, 43205 | |
| Contact: Geoffrey L Heyer, MD 614-722-4625 geoffrey.heyer@nationwidechildrens.org | |
| Principal Investigator: Geoffrey L Heyer, MD | |
More Information
No publications provided
| Responsible Party: | Geoffrey Heyer, Assistant Professor, Nationwide Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT01795469 History of Changes |
| Other Study ID Numbers: | IRB13-00033 (NCH IRB number) |
| Study First Received: | February 18, 2013 |
| Last Updated: | February 18, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Nationwide Children's Hospital:
|
POTS Orthostatic Adolescent |
Additional relevant MeSH terms:
|
Syncope Tachycardia Postural Orthostatic Tachycardia Syndrome Unconsciousness Consciousness Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases |
Signs and Symptoms Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Orthostatic Intolerance Primary Dysautonomias Autonomic Nervous System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013