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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02726776
Other study ID # A.10
Secondary ID
Status Completed
Phase N/A
First received March 15, 2016
Last updated April 5, 2016
Start date September 2015
Est. completion date December 2015

Study information

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

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science


Intervention

Other:
Suspension in a harness

Climbing


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Institute of Mountain Emergency Medicine

References & Publications (2)

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

Outcome

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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