NCT Number: NCT02726776
Suspension Syndrome
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.
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Notify MeKey information
Conditions
Age range
18 year–50 year
Sex eligibility
Male
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Climbing
OtherPrimary outcomes
-
Heart rate
Time frame: 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
-
Blood pressure
Time frame: 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
Secondary outcomes
-
Change in maximal Diameter of superficial femoral vein
Time frame: 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
Ultrasound measurement of the Diameter of the superficial femoral vein in millimeters
-
Change in interbeat-interval
Time frame: 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
electrocardiographic measurement of interbeat interval in milliseconds (ms)
Sponsors and collaborators
Lead sponsor
Institute of Mountain Emergency Medicine
Other
Registry information
Important dates
- Study start
- 2015
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Apr 4, 2016
- Registry last updated
- Apr 6, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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