CClinicalTrials.gg
CompletedNCT02726776Updated Apr 6, 2016

Suspension Syndrome

An interventional study of Suspension in a harness and Climbing in Circulatory Collapse, Circulatory Failure and Syncope, Vasovagal, Neurally-Mediated, sponsored by Institute of Mountain Emergency Medicine. Completed. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-06.

Sponsored by Institute of Mountain Emergency Medicine · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Circulatory Collapse
  • Circulatory Failure
  • Syncope, Vasovagal, Neurally-Mediated
  • Orthostatic Hypotension
03

In context

Syncope

226 studies on the registry are indexed under Syncope; 45 are open to participants now.

This study's enrollment of 20 is below the median of 79 across 126 interventional studies indexed under Syncope.

Browse Syncope studies →

Lead sponsor

Institute of Mountain Emergency Medicine is the lead sponsor of 20 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy volunteers
  • Age 18-50 years
  • ASA class 1
  • Signed informed consent

Exclusion criteria

Exclusion Criteria:

  • Age \<18 or >50 years
  • ASA class >1
  • Informed consent not signed
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Suspension without prior climbing

    Free Suspension in a harness after baseline measurements and without prior climbing

    Other: Suspension in a harness

  • Experimental
    Suspension with prior climbing

    Free Suspension in a harness after baseline measurements and after climbing in moderate intensity for 10 minutes

    Other: Suspension in a harness · Other: Climbing

Interventions

  • OtherSuspension in a harness
  • OtherClimbing
06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  1. Change in maximal Diameter of superficial femoral vein

    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

  2. Change in interbeat-interval

    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

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 21420883 ↗
  • Lee C, Porter KM. Suspension trauma. Emerg Med J. 2007 Apr;24(4):237-8. doi: 10.1136/emj.2007.046391. PubMed 17384373 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02726776
Lead sponsor
Institute of Mountain Emergency Medicine
Responsible party
Sponsor
First posted
Apr 4, 2016
Start date
Sep 2015
Primary completion
Nov 2015
Completion
Dec 2015
Last update
Apr 6, 2016

Study contacts

Peter Paal, MD, MBA
study director · Barts Heart Centre, London
Hermann Brugger, MD
study director · Eurac, Institute of mountain emergency medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion