Suspension Syndrome
Primary Purpose
Circulatory Collapse, Circulatory Failure, Syncope, Vasovagal, Neurally-Mediated
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Suspension in a harness
Climbing
Sponsored by
About this trial
This is an interventional basic science trial for Circulatory Collapse
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Suspension without prior climbing
Suspension with prior climbing
Arm Description
Free Suspension in a harness after baseline measurements and without prior climbing
Free Suspension in a harness after baseline measurements and after climbing in moderate intensity for 10 minutes
Outcomes
Primary Outcome Measures
Heart rate
Blood pressure
Secondary Outcome Measures
Change in maximal Diameter of superficial femoral vein
Ultrasound measurement of the Diameter of the superficial femoral vein in millimeters
Change in interbeat-interval
electrocardiographic measurement of interbeat interval in milliseconds (ms)
Full Information
NCT ID
NCT02726776
First Posted
March 15, 2016
Last Updated
April 5, 2016
Sponsor
Institute of Mountain Emergency Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02726776
Brief Title
Suspension Syndrome
Official Title
Suspension Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Mountain Emergency Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Circulatory Collapse, Circulatory Failure, Syncope, Vasovagal, Neurally-Mediated, Orthostatic Hypotension
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Suspension without prior climbing
Arm Type
Experimental
Arm Description
Free Suspension in a harness after baseline measurements and without prior climbing
Arm Title
Suspension with prior climbing
Arm Type
Experimental
Arm Description
Free Suspension in a harness after baseline measurements and after climbing in moderate intensity for 10 minutes
Intervention Type
Other
Intervention Name(s)
Suspension in a harness
Intervention Type
Other
Intervention Name(s)
Climbing
Primary Outcome Measure Information:
Title
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
Title
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 Outcome Measure Information:
Title
Change in maximal Diameter of superficial femoral vein
Description
Ultrasound measurement of the Diameter of the superficial femoral vein in millimeters
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
Title
Change in interbeat-interval
Description
electrocardiographic measurement of interbeat interval in milliseconds (ms)
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Paal, MD, MBA
Organizational Affiliation
Barts Heart Centre, London
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hermann Brugger, MD
Organizational Affiliation
Eurac, Institute of mountain emergency medicine
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21420883
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.
Results Reference
result
PubMed Identifier
17384373
Citation
Lee C, Porter KM. Suspension trauma. Emerg Med J. 2007 Apr;24(4):237-8. doi: 10.1136/emj.2007.046391.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://cloud.scientificnet.org/index.php/s/7vKbCJ1vs0UOYNN
Available IPD/Information Comments
Unfortunately available only in German
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://cloud.scientificnet.org/index.php/s/9RXyWhRxEgUgbTd
Available IPD/Information Comments
Unfortunately available only in German or Italian
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Suspension Syndrome
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