Orthostatic Hypotension Clinical Trial
Official title:
Suspension Syndrome
Verified date | April 2016 |
Source | Institute of Mountain Emergency Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
Suspension syndrome refers to a potentially life-threatening condition that can occur in unconscious persons after prolonged suspension in a harness. To date, our understanding of the pathophysiology and appropriate treatment is based primarily on case reports and expert opinion. The main pathophysiological hypothesis implicates blood pooling in the lower extremity and lack of return via muscle pumping. However, a recent French study could not support this hypothesis. Other mechanisms, such as a central vagal reflex may play a role in the pathophysiology of suspension syndrome. The aim of this study is to better understand the pathophysiological basis of suspension syndrome and to develop practical recommendations for prevention and treatment.
Status | Completed |
Enrollment | 20 |
Est. completion date | December 2015 |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Healthy volunteers - Age 18-50 years - ASA class 1 - Signed informed consent Exclusion Criteria: - Age <18 or >50 years - ASA class >1 - Informed consent not signed |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Institute of Mountain Emergency Medicine |
Lee C, Porter KM. Suspension trauma. Emerg Med J. 2007 Apr;24(4):237-8. Review. — View Citation
Pasquier M, Yersin B, Vallotton L, Carron PN. Clinical update: suspension trauma. Wilderness Environ Med. 2011 Jun;22(2):167-71. doi: 10.1016/j.wem.2010.12.006. Epub 2010 Dec 23. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Heart rate | Change from baseline (measurement at minute 0) -> suspension phase (minute 10, timepoint immediately before interruption of suspension phase [max 60 minutes]) -> minute 5 and minute 15 after suspension phase | No | |
Primary | Blood pressure | Change from baseline (measurement at minute 0) -> suspension phase (minute 10, timepoint immediately before interruption of suspension phase [max 60 minutes]) -> minute 5 and minute 15 after suspension phase | No | |
Secondary | Change in maximal Diameter of superficial femoral vein | Ultrasound measurement of the Diameter of the superficial femoral vein in millimeters | Change from baseline (measurement at minute 0) -> suspension phase (minute 10, timepoint immediately before interruption of suspension phase [max 60 minutes]) -> minute 5 and minute 15 after suspension phase | No |
Secondary | Change in interbeat-interval | electrocardiographic measurement of interbeat interval in milliseconds (ms) | Change from baseline (measurement at minute 0) -> suspension phase (minute 10, timepoint immediately before interruption of suspension phase [max 60 minutes]) -> minute 5 and minute 15 after suspension phase | No |
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