Suspension Syndrome

Orthostatic Hypotension Clinical Trial

Official title:

Suspension Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02726776
• Other study ID #: A.10
• 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

Related Conditions & MeSH terms

• Circulatory Collapse
• Circulatory Failure
• Hypotension
• Hypotension, Orthostatic
• Orthostatic Hypotension
• Shock
• Syncope, Vasovagal
• Syncope, Vasovagal, Neurally-Mediated

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